comparative study of extra amniotic saline

“COMPARATIVE STUDY OF EXTRA AMNIOTIC SALINE

INFUSION THROUGH INTRACERVICAL BALLOON

CATHETER AND FOLEYS BULB INDUCTION FOR

INDUCTION OF LABOUR”

Dissertation submitted to

THE TAMILNADU Dr. M.G.R MEDICAL UNIVERSITY

CHENNAI – 600032

with partial fulfillment of the regulations for the award of the degree of

M.S OBSTETRICS AND GYNAECOLOGY (BRANCH – II )

UNIVERSITY REGISTRATION NO. 221816302

COIMBATORE MEDICAL COLLEGE,

COIMBATORE

MAY 2020

CERTIFICATE

This is to certify that this dissertation on “COMPARATIVE

STUDY OF EXTRA AMNIOTIC SALINE INFUSION THROUGH

INTRACERVICAL BALLOON CATHETER AND FOLEYS BULB

INDUCTION FOR INDUCTION OF LABOUR” is a bonafide

research work done by Dr.GEETHA RAJAGOPALAN , under my

guidance and supervision during the academic year 2018-19. This has

been submitted in partial fulfillment for the award of M.S Degree in

OBSTETRICS AND GYNAECOLOGY (Branch II) by THE

TAMILNADU DR. M.G.R MEDICAL UNIVERSITY, CHENNAI –

600032.

Date: Guide

Prof. Dr.K. Murugalakshmi, M.D., D.G.O.,

Department of Obstetrics & Gynaecology

Coimbatore Medical College Hospital.

Date: Prof. Dr. R.Manonmani M.D., D.G.O.,

HOD,

Department of Obstetrics & Gynaecology


Date: Prof. Dr. B. Asokan M.S., M.ch.,

The Dean,


CERTIFICATE

This is to certify that this dissertation work titled




INDUCTION OF LABOUR” of the candidate Dr. GEETHA

RAJAGOPALAN with registration number 221816302 for the award of

M.S Degree in OBSTETRICS AND GYNAECOLOGY (Branch II) . I

personally verified the urkund.com website for the purpose of plagiarism

check I found that the uploaded thesis file contains from introduction to

conclusion pages and result shows Nine percentage (9%) of plagiarism in

the dissertation.

Guide and Supervisor sign with seal

DECLARATION

I solemnly declare that this dissertation entitled




INDUCTION OF LABOUR” was done by me at Coimbatore Medical

College Hospital, Coimbatore during the period of September 2018

to September 2019 under the guidance and supervision of

Prof.Dr.K.MURUGALAKSHMI MD DGO., This dissertation is

submitted to THE TAMILNADU DR. M.G.R MEDICAL

UNIVERSITY , towards partial fulfillment of the regulation for the

award of M.S DEGREE IN OBSTETRICS AND GYNAECOLOGY

(BRANCH II) .

PLACE :

DATE :

DR.GEETHA RAJAGOPALAN

ACKNOWLEDGEMENT

It gives me great pleasure in preparing this dissertation and I take

this opportunity to thank everyone who has made this possible.

It is most appropriate that I begin by expressing my gratitude to my

parents for their blessings.

My profound thanks to the Dean. Prof. Dr. B. ASOKAN M.S.,

M.ch., Coimbatore Medical College Hospital for permitting me to make

use of the clinical materials of our hospital.

My sincere thanks to Prof. Dr. R. MANONMANI M.D., D.G.O.,

Professor and Head of the Department, Department of Obstetrics &

Gynaecology, Coimbatore Medical College Hospital, Coimbatore, for her

profound enthusiasm and keen supervision of this work.

It gives me immense pleasure to express my deep sense of

gratitude and heartfelt thanks to Prof. Dr. K. MURUGALAKSHMI,

M.D., D.G.O., Professor, Department of Obstetrics & Gynaecology,

Coimbatore Medical College Hospital, Coimbatore, for her invaluable

guidance, constant encouragement, immense patience and great care

towards this dissertation.

I wish to express my heartfelt gratitude to Prof.Dr.N. GEETHA,

M.D., Professor, Department of Obstetrics & Gynaecology, Coimbatore

Medical College Hospital, Coimbatore, whose knowledge and experience

have guided and inculcated in me a sense of confidence.

My heartfelt thanks to Associate Professors Dr.Thilagavathy,

M.D(O.G)., Dr.Mohanasundari,M.D(O.G).,D.Ch., for their support

and encouragement in this study.

I am extremely thankful to all our Assistant Professors of

Department of Obstetrics and Gynaecology for their guidance and help

during this study.

I am ever grateful to my husband and family for being a constant

source of support and encouragement.

I extend my thanks to my entire Postgraduate colleagues for their

help and support.

I wish to thank, Statistician, for his suggestions and for providing a

scientific meaning to this study.

I would like to thank all my patients without whose cooperation,

this dissertation would never have seen the light of the day.

Dr. GEETHA RAJAGOPALAN

CONTENTS

S.NO CONTENTS PAGE NO

1. INTRODUCTION 1

2. AIMS AND OBJECTIVES 5

3. REVIEW OF LITERATURE 8

4. MATERIALS AND METHODS 31

5. STATISTICAL ANALYSIS AND RESULTS 38

6. DISCUSSION 71

7. SUMMARY 76

8. CONCLUSION 77

9. BIBLIOGRAPHY

10. ANNEXURES

PROFORMA

CONSENT FORM

MASTER CHART

1

INTRODUCTION

Labour starts spontaneously at term or near term in majority of

women. Induction of labour has become mandatory in modern day

obstetrics, because of medical or obstetric complications of pregnancy.

Definition of induction of labour

Stimulation of regular uterine contractions in a viable pregnancy

before the spontaneous onset of labour with or without rupture of

membranes after 28 wkw of gestation using mechanical or pharmacological

methods in order to generate progressive cervical dilatation and subsequent

delivery after fetus has attained maturity.

History of labour induction deals back to Hippocrates original

description of mammary stimulating and mechanical dilatation of cervical

canal.

Induction of labour is as old as Soraners of Greece, who was the first

person to induce labour in 100 A.D. Starting from the olden days of Soraners

to the modern days of obstetrics, induction of labour has gone through

different methods and modifications over the period of time by different

people.

2

Steamens started inducing labour electively for the convenience of

obstetricians or the expectant mother. Moshion was the first to describe

manual dilatation of cervix for induction of labour.

Induction of labour is accepted as an option in the management of

high risk pregnancies in which the continuation of pregnancy is likely to

adversely affect the maternal condition or the perinatal outcome.

Success of labour induction depends on the patient selection. Patient

to be induced must be term or nearing term with adequatepelvis, favorable

cervix & with a viable fetus.

“Mechanical induction of labour is defined as “Stimulation of

uterine contractions by means of non-pharmacological agents administered

intracervically to the patients with the aim of starting labour”

Mechanical methods for induction promote cervical ripening and

promote onset of labour by stretching of cervix.They are amongst the oldest

methods used to initiate labour.

Safety aspect of induction methods becomes most important, although

this could be at the expenses of effectiveness. Mechanical methods have

advantages over pharmacological methods as they are widely available, low

in cost with fewer side effects such as less uterine hyperstimulation.

3

Failed induction is termed when the uterus to fail to contract after

recommended attempts of stimulation, or the uterus contracts abnormally, or

cervix does not dilate, or the fetus is in jeopardy.

Although induction of labour is aimed at achieving vaginal delivery,

there is always an increased risk of caesarean section. Hence individual

variation is more important each patient needs to be viewed in the context of

her past obstetrical history and complications in the present pregnancy

cervical status before deciding on the mode of induction.

4

Risks of induction of labour

1. OPERATIVE DELIVERY: In both primi and muti IOL increases risk of

caesarean section. About 3 fold increase in primi compared to those

labouring spontaneously.

In muti it is doubled from 3.4% to 8.5%

2. UTERINE HYPERCONTRACTILITY: any agent used in IOL can

over stimulate the uterus which leads to prolonged or tonic uterine

contractions, fetal compromise and abnormal FHR patterns

3. UTERINE RUPTURE: rare but occurs in patients with uterine scar like

caesarean section or uterine perforation

4. FAILED INDUCTION: rates of failed induction is about 3%

5. IATROGENIC PREMATURITY

6. PAIN

No method of induction is free from complications, aim of this study

is to find the effective method with least complications. The study was

undertaken with the objective of observing difference in the responses of two

different mechanical methods of induction of labour. The Study was

conducted in Coimbatore Medical College, Coimbatore.

5

AIM AND OBJECTIVES

AIM :

The study is carried out to assess the effectiveness of Extra amniotic

saline infusion through intracervical balloon catheter and Foleys bulb

induction for induction of labour.

OBJECTIVES OF THE STUDY

• To study the effect of cervical ripening

• To study the oxytocin augmentation need

• To see the effect on the labour outcome

• To study the response difference in primi and multi

• To assess the maternal and fetal outcome

Study Centre

The study was undertaken in the Department of Obstetrics and

Gynaecology, Coimbatore Medical College, Coimbatore.

Study design

Prospective randomized control study conducted between September

2018-2019.

6

Sample size

100 antenatal mothers admitted in the hospital were included in this

study.

Inclusion criteria

1. Singleton pregnancy

2. Cephalic presentation

3. Absence of infection

4. Bishop score <5

5. Intact fetal membrane

Exclusion criteria

1. Low lying placenta

2. Malpresentation

3. Maternal infection

4. Rupture of membranes

5. Maternal comorbid illnesses like Gestational diabetes, Heart disease,

Chronic kidney disease

7

Induction indications

1. Post EDD pregnancies

2. oligohydroamnios

3. Intra uterine growth restriction

4. Gestational hypertension

5. Severe preeclampsia

CONCLUSION

EASI group showed more effective cervical ripening as compared to the

Foleys bulb induction group. Mean induction to active labour interval was

shorter in EASI as compared to Foleys bulb. Mean induction to delivery

interval was shorter in EASI group as compared to Foleys bulb induction.

Oxytocin augmentation necessity was more in Foleys bulb group. In both the

groups fetal outcome and maternal outcome were similar. EASI was found to

be more effective than Foleys bulb for cervical ripening and induction of

labour.

8

REVIEW OF LITERATURE

• Induction of labour is unavoidable in modern obstetrics because of the

maternal obstetrical and medical complications.

• The outcome of successful induction depends on the perfect balance

between the hazards of meddling and risks of avoidable complications

by non – intervention.

• Methods of induction of labour are listed here, some of which are

sexual intercourse, breaststimulation, purgatives, enemas,

acupuncture, stripping of membranes, amniotomy etc...

• Stripping of membrane was tried in 1810 by HAMILTON in England.

This was used mainly for cervical ripening and labour induction.

Risks include infection, premature rupture of membranes and bleeding from

placental contact.

• THOMAS DENMON first reported AMNIOTOMY –artificial rupture

of membranes in 1956 in London. It was effective only when the

cervix is favourable

9

• In 1820- BRUNNING HAUSEN introduced spongy tests to dilate the

cervix and thereby induce labour.

• In 1843 SCHREIBER stimulated labour electrically. In 1846

KIWISCH used hot vaginal douche. In the same year COHEN used

the extraamniotic fluid administration for labour induction.

• In 1865 WILSON used laminaria tents. Assumed probably function

through the disturbance of chorio amniotic decidual interphase and

thereby bringing lysosomal destruction and prostaglandin synthesis.

• In 1935 VANEULER, introduced the term prostaglandins. In

1971KARIM & SHARMA first induced labour with use of oral PGE2.

Since then a large number of reports have appeared in literature,

evaluating the efficacy of oral PGE2 for induction of labour.

• Oral PGE2 induces normal uterine contraction and soften the cervix

,and hence decreasing the resistance of the cervix to dilation.

• Cervical dilatation with a balloon catheter was introduced to BARNES

by WOODMAN in 1863. Since then several modifications of this

method are reported. One method is the infusion of extra amniotic

normal saline and is referred as EASI.

10

• In 1989 SCHREYER etal., found that extra amniotic saline infusion

resulted in greater increase in cervical dilatation

• SHERMAN in 1996 summarized the results of 13 trials with balloon

catheters and concluded that with or without saline infusion the

method cause rapid improvement in Bishop score and shortened

labours.

• VENGALIL and colleagues in 1998 proved that extra amniotic saline

infusion resulted in greater increase in Bishop score compared.

• HELMIN & MOLLER In 1998 reported catheter infusion to be

efficacious for cervical ripening than prostaglandin E2 gel.

• GOLDMAN & WIGTON in 1999 demonstrated a significantly higher

Bishop score with extra amniotic catheter infusion compared with

intracervical dinoprostone.

• GUINN & colleagues in 2000 compared induction of labour with

intracervical dinoprostone, laminaria plus intravenous oxytocin and

extraamniotic saline infusion. It was proved that induction to delivery

interval was less with extra amniotic saline infusion than laminaria or

dinoprostone gel.

11

• BUCCELLATO and associates in 2000 proved that there was greater

increase in Bishop score with extra amniotic saline infusion when

compared with 50ug of misoprostol.

• GUINN DAVIES , JK JONES, SULLIVAN L, WOLF D in 2004

conducted randomized control study for labour induction and

compared foley catheter with concurrent oxytocin and foley catheter

with extraamniotic saline infusion and proved that saline infusion was

effective.

• SHARAMI, MILANI in 2005 conducted randomized control trial

compared cervical ripening with PGE2 gel & extra amniotic

salineinfusion and demonstrated that extra amniotic saline infusion

was effective.

• KARJANE NW, BROCK EC in 2006 done a prospective study for

induction of labour using foley balloon with and without amniotic

saline infusion and showed with saline infusion induction is more

effective.

• SAIMA QAMAR, ADELLAR in 2012 conducted a comparative study

of PGE2 gel, PGE2 pessary and extra amniotic saline infusion with

12

oxytocin for induction of labour and found saline infusion have greater

increase in Bishop score compared to PGE2 gel and pessary.

Induction of labour

Induction implies stimulation of contractions before the spontaneous

onset of labour ,with or without ruptured membranes.

Indications include membrane rupture without labour, gestational

hypertension, nonreassuring fetal status, post term pregnancy, diabetes.

Contraindications include macrosomia, multifetal gestation, severe

hydrocephalus, malpresentation, uterine incision type, contracted or distorted

pelvic anatomy, abnormal placentation, active genital herpes etc.

Risks –Maternal complication rates that are increased in association with

labour induction ---caesarean delivery, chorioamnionitis and uterine atony.

Caesarean delivery: This is especially increased in nulliparous

undergoing induction.

Rate of caesarean delivery following elective induction was increased in

women without antepartum complications and with a Bishops score of 7 or

greater when compared with spontaneous labour.

13

Chorioamnionitis: Women whose labour is induced have an increased

incidence of chorioamnionitis compared with spontaneous labour.

Uterine atony: Postpartum atony and hemorrhage are more common in

women undergoing induction.

Regimens for labour induction

Pharmacological techniques:

Prostaglandin E2

Prostaglandin E1

Mechanical techniques:

• Foleys catheter

• Extra amniotic saline infusion (EASI)

• Hygroscopic cervical dilators

• Membrane stripping

APPLIED PHYSIOLOGY

• Uterine cervix contain extra cellular material proteins, Collagen (type

I &III), elastin, glycosaminoglycan, especially dermatin sulfate,

14

hyaluronic acid, heparin sulphate, water. Only 10- 15% cervical tissue

is composed of smooth muscle.

• It is well recognized that the cervix loses its firmness in late pregnancy

and becomes soft and compliant. During labour it further loses its

elasticity , viscosity and plasticity.

• Hyaluronic acid contributes to accumulation of water within the

substance of cervix, which destabilizes the collagen fibrils,

contributing to cervical ripening.

• Glycosaminoglycans increase and dermatin sulphate decrease at

labour. Proteolytic enzymes in cervix degrade cross linked collagen.

• Collagenase is an enzyme that breaks down collagen. Leucocyte

elastase is another enzyme that breaks elastin, proteoglycans.

• Apart from enzymatic change, cervical remodeling takes place with

advancing gestation. Abnormal remodeling of collagen may contribute

to dysfunctional labour.

• Based on current evidence, both prostaglandins and relaxin hormones

playa key role in process of cervical ripening. Cervical ripening occur

with increase in formation of gap junctions and increase in myometrial

contractility.

15

PHYSIOLOGY OF CERVICAL RIPENING

16

CERVICAL RIPENING

18

Human uterine cervix is a complex heterogeneous organ that

undergoes intensive changes throughout gestation and parturition.

The external os is connected to the internal os by a slender passage

called endocervical canal.

Cervical mucosa is lined with tall columnar epithelium and contains

many large glands which are lined by columnar epithelium which ends

19

abruptly at the level of external os, giving way to stratified squamous

epithelium that covers the portiovaginalis and extends to the vagina proper.

Cervix is composed of an extra cellular matrix consisting

predominantly of collagen with elastin and proteoglycans and celluar

portion consisting of smooth muscle and fibroblasts, epithelium and blood

vessels. Abnormal remodeling of collagen contribute to dysfunctional

labour.

Extensive remodeling of cervix occurs from early gestation to

postpartum period. Water content of cervix increases from 80% in non-

active state to 86% in late pregnancy, the remodeling process involves

properly timed biochemical cascades, interaction between the cellular

matrix and cervical stromal inflammatory cells such as neutrophils and

macrophages.

Cervical undergoes destructive procedure process through which the

cervix dilates to facilitate delivery.

Extracellular matrix (ECM)

Collagen is the predominant content of the ECM. Cervical collagen

consists of type II (70%) and type III (30%).

20

These proteins are rigid and arranged as a triple helix, the collagen can

be crossed-lined into fibrils, fibers and bundles. Elastin is another important

component of Extra Cellular Matrix (E.C.M) of cervix. Elastin fibers are

organized in parallel to and between collagen fibers.

Cellular component

Smooth muscle cells (20%) and fibroblasts (60%) make up the cellular

component of uterine cervix. Smooth muscle cells are embedded in an ECM

composed mainly of collagen fibers.

21

Role of hormones in cervical ripening

Hormonal manipulation may also have a role in cervical ripening.

Human cervical connective tissue contains both estrogen and progesterone

receptors.

As term approaches, there is a down regulation of both estrogen and

progesterone receptor, which may be caused by increased turnover of the

receptor proteins.

Estrogen and its precursors stimulate collagenase production in the

pregnant human cervix and progesterone maintain high level of enzyme that

degrade hyaluronic acid, thereby keeping its level in the cervix low until

term when progesterone and progesterone receptor level decrease.

Relaxin, an ovarian hormone released during gestation (H 1 is

expressed by ovary and H2 by both deciduas and trophoblast), it softens the

cervix.

The IL’s (interleukins) have also been suggested to play an important

role in the process because they are chemotactic for neutrophils. IL-8

involved in neutrophils mediated cervical ripening. IL-6 is known to

stimulate the production of PGE2 by amnion and deciduas.Recent studies

22

have indicated that IL-6 and TNF levels in amniotic fluid are elevated in the

active phase of both preterm and term labour.

Onset of labour

Uterine stretch and parturition

Fetal growth significantly increases in myometrial tensile stress and

amniotic fluid pressure.

With uterine activation, stretch is required for inductionspecific

contraction-associated proteins (CAPs).

Stretch increases expression of the gap junction protein-connexin 43,

as well as oxytocin receptors.

Clinical report for a role of stretch comes from the observation that

multifetal pregnancies and hydramnios are at a much greater risk for preterm

labour than singletons.

23

CERVICAL RIPENING

Methods of cervical ripening

1. NON MEDICAL:

• Sexual intercourse

• Herbal remedies

• Castor oil

• Hot baths

• Breast stimulation

• Acupuncture

• Sweeping of membranes

2. MECHANICAL:

• Foleys catheter

• Extraamniotic saline infusion

• Laminaria tent

24

3. PHARMACOLOGICAL:

• Oxytocin

• PGS

• Relaxin ,

• Estrogen

4. SURGICAL

ARM

Non- medical methods

• Sexual intercourse was said to induce labor as the human semen is a

source of natural PGS

• Nipple stimulation does not have any effect in IOL

• Herbal remedies, castor oil, enema, accupuncture had notbeen

adequately proved.

• Sweeping of membranes or stripping is an age old method of IOL .

25

• Simple technique were a finger is inserted through the cervix and

swept around the lower uterine segment above the internal os in a

circular motion.

• It works by the release of PGS .

• It often stimulates uterine contractions and ripens the cevix.

Mechanism of action of EXTRA AMNIOTIC SALINE INFUSION

• Mechanical action of Foley’s catheter is similar to stripping and

causes the release of prostaglandins, cytokines in the decidual cells.

• The lytic enzymes like Phospholipase A, which acts on phospholipids

to form Arachidonic acid, which in turn converted to Prostoglandins.

• Saline infusion cause mechanical stretching of isthmial region thereby

production of PGE & F

Success of induction depends on

• Period of gestation – uterus is more sensitive near term or post term.

• Gravida – induction is more successful in parous women.

• Sensitivity of uterus

26

• Pre induction scoring – patients with Bishop score >6 respond well to

induction than those with unfavorable Bishop score <5

Pre induction scoring

In this study, Bishop scoring system and partogram is used. It is a

time– honored fact that Bishop score is a sensitive indicator that predicts

successful induction of labour.

Bishop Score 0 1 2 3

Dilatation 0 1-2 3-4 5-6

Effacement 0-30 4-60 60-70 80+

Station -3 -2 -1/0 +1/+2

Consistency Firm Medium Soft

Os Position Posterior Mid Position Anterior

27

MODIFIED BISHOPS SCORE

Factor / Score 0 1 2 3

Dilatation (cm) <1 1-2 2-4 >4

Cervical length (cm) >4 2-4 1-2 <1

Station (cm) -3 -2 -1/0 +1/+2

Consistency Firm Moderate Soft -

Position Posterior Mid; Anterior - -

29

Partogram

It is graphic representation of progress of labour together with information

about fetal and maternal condition against time.

The components of partogram are

1. Cervical dilatation in cm

2. Descent of the presenting part

3. Frequency & duration of uterine contractions

4. Fetal heart rate

5. Rupture of membranes and color of amniotic fluid

6. Maternal pulse rate

7. Blood pressure

8. Urine output

9. Drugs used

30

• An alert line is drawn at the rate of expected progress that is

1cm/hr. An action line is drawn parallel to alert line but 4 hours

apart. If labour is abnormal , then cervicograph deviates towards

rjght or crosses the action line when definite action is required.

• Partogram is universally accepted method to assess the progress of

labour.

31

METHODOLOGY

The subjects of the study were selected from the patients who came to

the labour ward in Coimbatore medical college & Hospital from September

2018-september 2019 as a time bound study.

The study was done in 100 women after counselling about the

methods of induction.50 women were assigned to induction by extra

amniotic saline infusion and 50 assigned to Foleys bulb induction.

Both the groups were randomly selected and reactivated.

A prospective study of all cases of pregnant women who got admitted

to labour ward requiring induction of labour were randomly assigned to

EASI/Foleys bulb induction between September 2018-September 2019.

Patients were selected as per the inclusion criteria and the exclusion

criteria.

After obtaining informed consent from the patients, a detailed history,

complete physical examination, Bishops score assessment, routine

investigations were done for all the patients .

Group A—Extra amniotic saline infusion with Foleys catheter

(20-22).

32

Group B---Foleys bulb induction with Foleys catheter .

Patients with Bishop score 0-5 and meeting inclusion and exclusion

criteria were included .50 patients in each group were studied. The groups

were compared with respect to maternal age, parity, gestational age, reason

for induction, initial Bishops scores, side effects, intrapartum complications,

delivery mode ,induction delivery interval, apgar scores.

The statistical methods used were students t-test, chi square test.

33

PROCEDURE

After informed consent was obtained, women were assigned to receive

EASI or Foleys bulb induction.

Group A—Extra amniotic saline infusion group

• All women were done a speculum examination in lithotomy position

.Vulva, vagina and cervix cleaned with betadine solution.

• Prophylactic antibiotics given.20-22F Foleys was inserted into the

cervical canal beyond the internal os under strict aseptic precautions

and under direct visualisation and the balloons were inflated with 30

ml normal saline water.

• Outlet of Foleys catheter was connected to a normal saline bottle

through a drip set and 150 ml of normal saline was injected into the

extra amniotic space and catheter was blocked and taped to the medial

aspect of thigh.

• By monitoring pulse rate, uterine contractions and fetal heart rate

every 1/2hourly and BP 4th hourly and was watched for bleeding

PV/draining PV.

34

• Cervix was assessed for Bishop score after 6hrs, 12hrs,18 hrs or when

the catheter was expelled whichever occurred first.

• Oxytocin induction/augmentation was done as per the labour induction

protocol.

Group B—Foleys bulb induction

• All women were done a speculum examination lithotomy position.

Vulva, vagina and cervix cleaned with betadine solution.

• Prophylactic antibiotics given.20-22F Foleys was inserted into the

cervical canal beyond the internal os under strict aseptic precautions

and under direct visualisation and the balloons were inflated with 80

ml normal saline water and the catheter was placed in traction by

taping it to the medial aspect of thigh.

• Maternal pulse rate, uterine contractions, fetal heart rate was

monitered every 1/2hourly and BP 4th hourly and was watched for

bleeding PV.

35

• Cervix was assessed for Bishop score after 6hrs, 12hrs ,18 hrs or when

the catheter was expelled whichever occurred first.

• Further oxytocin induction/augmentation was done as per the labour

induction protocol by syntocin infusion of 5U in 500 ml normal saline

starting with 30 minutes interval.

36

Extra Amniotic Saline Induction

37

Foley Bulb Induction

38

STATISTICAL ANALYSIS

In both the groups, the patients selected belonged to similar age group,

parity and weeks of gestation and Bishops score. The mean Bishops score

was significantly increased in 6,12 hours in primi gravid as compared to

Foleys bulb induction.

In patients with extra amniotic saline infusion, majority went in for

active labour 6-12 hours, whereas in Foleys bulb induction ,majority went in

for active labour in 2-24 hours. Induction delivery interval was significantly

reduced in primigravida in cases of EASI as compared to Foleys bulb

induction.

Usage of oxytocin augmentation was increased in Foleys group of

patients with Foleys bulb induction.

Vaginal delivery was found to be more in EASI group 53.1% as

compared to 46.9% in Foleys bulb group.

There was no significant difference in the neonatal outcome in both

the groups.

39

RESULTS

Table 1: Distribution of study participants

Groups Frequency Percent (%)

EXTRA AMNIOTIC

SALINE INFUSION

50 50.0

FOLEYS BULB

INDUCTION

50 50.0

Total 100 100.0

50%50%

Distribution of study participants

EXTRA AMNIOTIC SALINE

INFUSION

FOLEYS BULB INDUCTION

40

Table 2: Mean age of the study group

Groups N Mean SD

EXTRA AMNIOTIC

SALINE INFUSION

50 25.06 3.930

FOLEYS BULB

INDUCTION

50 25.98 5.220

24.6

24.8

25

25.2

25.4

25.6

25.8

26


INFUSION


25.06

25.98

Mean age

41

Table 3: Age distribution among study groups

Age in groups

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

<20 years 6 46.2% 7 53.8%

.627

21-25 years 23 53.5% 20 46.5%

26-30 years 17 53.1% 15 46.9%

>31 years 4 33.3% 8 66.7%

0

5

10

15

20

25

<20 21-25 26-30 >31

6

23

17

4

7

20

15

8

Age distribution


INFUSION


42

Table 4: Gravida distribution among study groups

Gravida

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

G1 22 56.4% 17 43.6%

.458

G2 18 52.9% 16 47.1%

G3 8 36.4% 14 63.6%

G4 2 40.0% 3 60.0%

0

5

10

15

20

25

G1 G2 G3 G4

22

18

8

2

1716

14

3

Gravida distribution


INFUSION


43

Table 5: Gestational age distribution among study groups

Gestational age

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

<36 weeks 50 50% 50 50%

.889 37-40 weeks 38 51.4% 36 48.6%

>41 weeks 9 45.9% 11 55.0%

0

5

10

15

20

25

30

35

40

45

50

<36 37-40 41

50

38

9

50

36

11

Gestational age


INFUSION


44

Table 6: Indication for induction distribution among study groups

Indication for

induction

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

Prolonged EDD 19 47.5% 21 52.5%

.733

PIH 9 40.9% 13 59.1%

Oligohydramnios 12 57.1% 9 42.9%

Gestational diabetes

mellitus

6 54.5% 5 45.5%

IUD 4 66.7% 2 33.3%

0

5

10

15

20

2519

9

12

64

21

13

9

5

2

Indication for induction


INFUSION


45

Table 7: Bishop score at 0 hour among study groups

0 hour

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

1 1 50.0% 1 50.0%

.979 2 29 49.2% 30 50.8%

3 20 51.3% 19 48.7%

0

5

10

15

20

25

30

0 1 2

1

29

20

1

30

19

Bishop score at 0 hour


INFUSION


46

Table 8: Bishop score at 6 hours among study groups

6 hours

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

<5 16 61.5% 10 38.5%

.161 6-10 34 45.9% 40 54.1%

0

5

10

15

20

25

30

35

40

<5 6-10

16

34

10

40

Bishop score at 6 hours


INFUSION


47


12 hours

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

<5 6 100.0% 0 0.0%

.001* 6-10 36 42.4% 49 57.6%

>11 8 88.9% 1 11.1%

0

5

10

15

20

25

30

35

40

45

50

<5 6-10 >11

6

36

8

0

49

1



INFUSION


48


18 hours

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

<5 0 0.0% 1 100.0%

.043* 6-10 5 83.3% 1 16.7%

>11 1 16.7% 5 83.3%

0

0.5

1

1.5

2

2.5

3

3.5

4

4.5

5

<5 6-10 >11

0

5

11 1

5



INFUSION


49

Table 11 : Mean Bishop score at 0of parity among the study group


INFUSION FOLEYS BULB INDUCTION

P

value

Mean Bishop

score at 0

PRIMI

N=22

MULTI

N=28

PRIMI

N=17

MULTI

N=33

Mean SD Mean SD Mean SD Mean SD

2.09 .426 2.61 .497 1.94 .243 2.58 .502 .000*

EXTRA AMNIOTICFOLEYS BULB

SALINE INFUSIONINDUCTION

0

0.5

1

1.5

2

2.5

3

Primi Multi Primi Multi

2.09

2.61

1.94

2.58

Mean Bishop score at 0

50

Table12 : Mean Bishop score at 6of parity among the study group



P

value

Mean Bishop

score at 6

PRIMI

N=22

MULTI

N=28

PRIMI

N=17

MULTI

N=33


7.05 1.21 5.46 .793 5.82 1.01 6.36 .653 .000*



0

1

2

3

4

5

6

7

8


7.05

5.465.82

6.36


51

Table 13 : Mean Bishop score at 12of parity among the study group



P

value

Mean Bishop

score at 12

PRIMI

N=22

MULTI

N=28

PRIMI

N=17

MULTI

N=33


9.64 1.52 6.43 1.47 8.47 .624 9.15 .795 .000*



0

1

2

3

4

5

6

7

8

9

10


9.64

6.43

8.479.15


52

Table 14 : Incidence of LSCS

Mode of

delivery

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

No % No %

LSCS 13 46.4% 15 53.6%

12

12.5

13

13.5

14

14.5

15


INFUSION


13

15

LSCS

53

Table 15 : Incidence of LSCS

LSCS


INFUSION

N=13

FOLEYS BULB

INDUCTION

P

value PRIMI MULTI PRIMI MULTI

No % No % No % No %

LSCS 7 53.8% 6 46.2% 6 40.0% 9 60.0% .837



0

1

2

3

4

5

6

7

8

9


7

6 6

9

LSCS

54

Table 16: Mode of induction among study groups

Mode of

induction

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

0 50 100.0% 0 0.0%

.000* 1 0 0.0% 5 100.0%

0

5

10

15

20

25

30

35

40

45

50

1 2

50

00

5

Mode of induction


INFUSION


55

Table 17: Oxytocin infusion among study groups

Oxytocin

Infusion

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION P value

No % No %

0 24 54.5% 20 45.5%

0.420

1 26 46.4% 30 53.6%

0

5

10

15

20

25

30

0 1

24

20

26

30

Oxytocin infusion


INFUSION


56

Table 18: Oxytocin infusion among parity in study groups

Oxytocin

infusion


INFUSION

FOLEYS BULB

INDUCTION

P


No % No % No % No %

0 19 79.2% 5 20.8% 5 75.0% 15 75.0%

.000* 1 3 11.5% 23 88.5% 12 40.0% 18 60.0%

0

5

10

15

20

25


19

5 5

15

3

23

12

18

Oxytocin infusion among parity

57

Table19: Mean Induction labour intervalof the study group

Groups N Mean SD P VALUE

EXTRA AMNIOTIC

SALINE INFUSION

50 9.80 2.753

.949

FOLEYS BULB

INDUCTION

50 9.83 1.834

9.785

9.79

9.795

9.8

9.805

9.81

9.815

9.82

9.825

9.83


INFUSION


9.8

9.83

Mean Induction labour interval

58

Table 20: Induction Labour Interval among study groups

Induction

Labour Interval

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

<6 5 83.3% 1 16.7%

.007* 7-12 32 41.6% 45 58.4%

>13 10 66.7% 5 33.3%

0

5

10

15

20

25

30

35

40

45

<6 7-12 >13

5

32

10

1

45

5

Induction Labour Interval


INFUSION


59

Table 21: Induction Labour Interval among parity in study groups

Induction

Labour

Interval


INFUSION

FOLEYS BULB

INDUCTION

P


No % No % No % No %

<6 6 100.0% 0 0.0% 0 0.0% 0 0.0%

.000* 7-12 16 47.1% 18 52.9% 12 26.7% 33 73.3%

>13 0 0.07% 10 100.0% 5 100.0% 0 66.0%

EXTRA AMNIOTIC FOLEYS BULB

SALINE INFUSION INDUCTION

- < 6 - 7-12 - >13

0

5

10

15

20

25

30

35


6

0 0 0

1618

12

33

0

10

5

0

Induction Labour Interval among

parity

60

Table 22: Mean Induction labour intervalof parity among the study group



P

value

Induction

labour

interval

PRIMI

N=22

MULTI

N=28

PRIMI

N=17

MULTI

N=33


7.68 1.60 28 11.4 11.94 1.24 8.74 .885 .000*

0

5

10

15

20

25

30


7.68

28

11.94

8.74

Mean Induction labour interval

61

Table 23: Mean Induction delivery intervalof the study group

Groups N Mean SD P VALUE

EXTRA AMNIOTIC

SALINE INFUSION

50 15.96 2.962

.000*

FOLEYS BULB

INDUCTION

50 17.86 2.138

15

15.5

16

16.5

17

17.5

18


INFUSION


15.96

17.86

Mean Induction delivery interval

62

Table 24: Mean Induction delivery intervalof parity among the study group



P

value

Induction

delivery

interval

PRIMI

N=22

MULTI

N=28

PRIMI

N=17

MULTI

N=33


14.00 2.30 17.50 2.48 20.24 1.25 16.64 1.29 .000*



0

5

10

15

20

25


14

17.5

20.24

16.64

Mean Induction delivery interval of

parity

63

Table 25: Mean Induction delivery intervalof gravida among study groups

Induction

delivery

interval



PRIMI MULTI PRIMI MULTI

No % No % No % No %

6-12 6 85.7% 1 14.3% 1 50.0% 1 50.0%

13-24 16 37.2% 27 62.8% 17 34.0% 33 66.0%



- < 6-12 - 13-24

0

5

10

15

20

25

30

35

Primi Multi Primi Mult

6

1 1 1

16

27

17

33

Mean Induction delivery interval of

gravida

64

Table 26: Mode of delivery among study groups

Mode of delivery

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

Labour natural 26 53.1% 23 46.9%

.940 LSCS 13 46.4% 15 53.6%

Forceps 5 50.0% 5 50.0%

Vacuum 6 46.2% 7 53.8%

0

5

10

15

20

25

30

Labour

natural

LSCS Forceps Vacuum

26

13

56

23

15

57

Mode of delivery


INFUSION


65

Table 27: Indication for LSCS among study groups

Indication for

LSCS

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

Fetal distress 7 46.7% 8 53.3%

.360 Failed induction 6 54.5% 5 45.5%

Severe PIH 0 0 2 100%

0

5

10

15

20

25

30

35

40

45

Fetal distress Failed

induction

Severe PIH

26

45

5

23

43

5

Indication for LSCS


INFUSION


66

Table 28:Neonatal outcome among study groups

Neonatal outcome

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

NICU admission 6 50.0% 6 50.0%

1.000 Good outcome 44 50.0% 44 50.0%

0

5

10

15

20

25

30

35

40

45

NICU admission Good outcome

6

44

6

44

Neonatal outcome


INFUSION


67

Table 29: Intrapartum maternal distress among study groups

Intrapartum

maternal distress

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

No 46 50.0% 46 50.0%

1.000 Yes 4 50.0% 4 50.0%

0

5

10

15

20

25

30

35

40

45

50

NO YES

46

4

46

4

Intrapartum maternal distress


INFUSION


68

Table 30: PPH among study groups

PPH

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

No 46 50.0% 46 50.0%

1.000 Yes 4 50.0% 4 50.0%

0

5

10

15

20

25

30

35

40

45

50

NO YES

46

4

46

4

PPH


INFUSION


69

Table 31:Intrapartum Pyrexia among study groups

Intrapartum

Pyrexia

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

No 48 51.1% 46 48.9%

.400 Yes 2 33.3% 4 66.7%

0

5

10

15

20

25

30

35

40

45

50

NO YES

48

2

46

4

Intrapartum Pyrexia


INFUSION


70

Table 32: Postpartum sepsis among study groups

Postpartum

sepsis

EXTRA AMNIOTIC

SALINE INFUSION

FOLEYS BULB

INDUCTION

P value

No % No %

No 48 50.0% 48 50.0%

1.000 Yes 2 50.0% 2 50.0%

0

5

10

15

20

25

30

35

40

45

50

NO YES

48

2

48

2

Postpartum sepsis


INFUSION


71

DISCUSSION

The study was conducted in Institute of Obstetrics and Gynaecology,

Coimbatore to compare the efficacy of Extra amniotic saline infusion and

Foleys bulb for induction of labour. The study was done in 100 patients.50

patients were induced with extra amniotic saline and 50 patients were

induced with Foleys bulb induction. Both the groups has patients of similar

age, parity and gestational age.

Change in Bishops score

In my study, both the groups had patient who were induced with

almost similar Bishops score initially.

Mean Bishops score at 0 hours was 2.09 in primi with EASI and 1.94

with Foleys bulb induction. Mean Bishops score at 6 hours was 7.05 in primi

with EASI and 5.82 with Foleys bulb induction. Mean Bishops score at 12

hours was 9.64 in primi with EASI and 8.47 with Foleys bulb induction.

Mean Bishops score at 0 hours was 2.61 in multigravida with EASI

and 2.58 with Foleys bulb induction. Mean Bishops score at 6 hours was

5.46 in multigravida with EASI and 6.36 with Foleys bulb induction. Mean

Bishops score at 12 hours was 6.43 in multigravida with EASI and 9.15 with


72

Mean Bishops score improved in higher rate in EASI in primi as

compared to Foleys bulb induction. The difference is statistically significant

(P<0.01)

Induction to Active labour interval

In my study, majority of patients induced with EASI established

active labour within 9.8 hours ,whereas in Foleys bulb induction ,active

labour was established in 9.83 hours. Mean induction active labour interval

in primi with EASI was 7.68 hours and in Foleys bulb induction was 11.94

hours . Mean induction active labour interval in multi with EASI was 28 and

in Foleys bulb induction was 8.74 hours . The difference between the two

groups is statistically significant(P<0.01).EASI was found to be more

effective in causing cervical ripening than Foleys bulb induction in primi.

OXYTOCIN AUGMENTATION

In my study ,oxytocin usage in EASI was 46.4% and Oxytocin usage

in Foleys induction group was about 53.6% for augmentation of labour. The

difference is statistically significant(P<0.01).

73

Induction to Delivery interval

In my study, majority of patients induced with EASI delivered within

14 hours in primi and 17.5 hours in multi where as in Foleys bulb induction

,delivered within 20.24 hours in primi and 16.64 in Multigravida .Mean

induction delivery interval in induced with EASI was 15.96 hours and with

Foleys bulb induction was 17.86 hours .The difference between the two

groups is ststistically significant(P<0.01)

Mode of delivery

In my patients induced with EASI 53.1% of patients delivered

vaginally, whereas in patients with Foleys bulb induction 46.9% had vaginal

delivery. LSCS rate was only 46.4%in EASI as compared to about 53.6% in


Indication of caesarean delivery

In my study, incidence of caesarean delivery was significantly lower

in 46.4% in EASI as compared to 53.6% Foleys bulb induction . Incidence of

failed induction in EASI 54.5% and Foleys bulb induction is 45.5%.

Incidence of fetal distress was 46.7 % in EASI whereas it was 56.3% in


74

Bucecellate et al (2000)also reported that failure to progress and non

reassuring fetal heart rate were the common cause for caesarean delivery.

GUNN et al (2004) reported that fetal distress was the most common cause

for LSCS. Sharami et al (2005)reported that cervical dystonia was the most

common cause for LSCS.

Fetal Outcome

In my study fetal outcome and admission in NICU was similar in both

the groups. The most common cause for NICU admission was birth asphyxia

and meconium aspiration. GUNN et al reported no significant maternal and

neonatal morbidities.

Maternal outcome

In my study puerperal pyrexia was comparable in both the groups.

There was no difficulty in intra cervical Foleys catheter insertion.

JANET et al reported technical difficulty in one patient due to cervix

partition. SCREYER et al reported mild bleeding after Foleys bulb insertion.

SHERMAN et al reported rupture of membranes at the time of

insertion. Majority of the patients who were induced belonged to the age

group 20-25 years. Study conducted by JANEI et al (1999),

75

SHARAMI(2005)showed that the majority of patients belonged to 20-30

years of age.

Majority of patients were Primigravida –56.4%.The study conducted

by JANEI et al (1999)and GUNN et al (2004)also had maximum number of

primigravidas.

Majority of the patients were induced between 40=41 weeks of

gestation. EASI—19,Foleys --- 21.The study of KARJANE et al

(2006)showed that post delivery was the most common cause for induction.

76

SUMMARY

Improvement in Bishops score was more in EASI than the Foleys bulu

induction. Mean induction to active labour interval (ILI) was shorter in EASI

than Foleys bulb induction .Mean induction to delivery interval was shorter

in EASI than Foleys bulb induction.

Mean induction to active labour interval and mean induction to

delivery interval were shorter in multi of both the groups as compared to

primi of both the groups . Regarding age parity, gestational age and the

indication for induction there was no significant difference in both the

groups.

53.1% of patients in EASI infusion had labour naturale when

compared to 46.9% Foleys bulb induction. LSCS incidence for failed

induction in EASI was 46.4% as compared to 53.6% in Foleys bulb

induction.

77

CONCLUSION

Cervical ripening was more effective in the EASI group in primi as

compared to Foleys bulb induction. Mean induction to active labour interval

was shorter in the EASI when compared to Foleys bulb induction. Mean

induction to delivery interval was shorter in the EASI when compared to


Oxytocin usage was lower in EASI group than Foleys bulb induction.

Response to primi are better than multi in both the groups. Fetal and

maternal outcome were similar in both the groups.

EASI was found to be more effective, cheeper and readily available

method for cervical ripening and induction of labour. Incidence of LSCS in

EASI was 46.4% as compared to Foleys induction which was 53.6%.

Neonatal admissions were similar in both the groups.

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Cervical ripening:a randomised comparison between Intravaginal

misoprostol and anIntracervical balloon catheter combined with

IntravaginalDinoprostone. Am JObstetGynecol 1998; 178:1333-

40

37. Rouben D, Arias F, A randomised trial of Extra amniotic saline

infusion plusintracervical Foley catheter balloon versus

Prostaglandin E2 vaginal gel forripening the cervix and inducing

labor in patients with unfavourable cervicesObstetGynecol 1993

Aug; 82(2): 290-4

38. Sanchez Ramos L, Kaunitz AM, Del valleGO,DeIke I, Schroeder

P, Briones D.

39. Labor induction with the prostaglandin El versus oxytocin; a

randomised trial.ObstetGynecol 1993; 81:332-6

40. Sawai SK, Williams MC, O'Brien W, et al. Sequential outpatient

application of intravaginal PGE2 gel in the management of Post

date pregnancies. ObstetGynecol 1991; 78:19-22

41. Sciscione AC, McCullough H, Manley JS ,Shlossman PA,

Colmorgen GHC:A prospective randomised comparison of Foley

catheter insertion versus intra cervical Prostaglandin E2 gel for

pre induction cervical ripening. Am J ObstetGynecol 180:55,

1999

42. Sherman DJ, Frenkel E, Pansky M, Caspi E, Bukovsky I, Langer

R Balloon cervical ripening with Extra-amniotic Saline infusion

or PGE2: a double -blind, randomised controlled study

ObstetGynecol 2001 Mar; 97(3): 375-80

43. Sherman DJ, FrenkelEJovbin J, Arieli S, Caspi E, Bukovsky I

Ripening of the unfavorable cervix with extraamniotic catheter

balloon: Clinical experienceand review ObstetGynecolSurv 1996;

51:627-7

44. Srisomboon J, Tongsong T, Tosiri V. Preinduction cervical

ripening with intra vaginal Prostaglandin El: a randomised

controlled trial. J obstetGynecol Res1996; 22:119-24

45. Trofatter, Cervical ripening. Clin. Obstet Gynecoll992: 35:476-86

46. Trootwijk AL, Vanveen JBC, Doesburg WH. Pre-induction intra-

cervicalapplication of a highly viscous Prostaglandin E2 gel in

pregnant women withan unripe cervix. Eur J

obstetGynecolReprodbiol 1992; 43:105-11

47. Vengalil SR, Guinn DA, Olabi NF, Burd LI, Owen. A

randomised trial of misoprostol and Extra amniotic saline

infusion for Cervical ripening and laborinduction J

ObstetGynecol 1998 May; 91(5 Pt 1): 774-9

48. Wing D, Jones M, Rahall A, Goodwin M, Paul R. A comparison

of Misoprostol and Prostaglandin E2 gel for Pre induction

Cervical ripening andLabour induction. Am J ObstetGynecol

1995; 173:1137-42

49. Wing DA, Ortiz -Omphroy G, and Paul RH. A comparison of

intermittent vaginal administration of misoprostol with

continuous dinoprostone forcervical ripening and labor induction.

Am J ObstetGynecol 1995; 172:1811-6

50. Woodman WB. Induction of labor at the eight month, and

delivery of a living child i n less than four hours by Dr.Barne's

method Lancet 1863; 1:10-11

51. Zanini A, Guidini A, Norchi S, Beretta E, Cortinovis I, Bottino S,

Preinductioncervical ripening with PGE2 gel: Intracervical versus

intravaginalroute. ObstetGynecol 1990; 76: 681-3

PROFORMA

NAME:

AGE:

IP NO:

ADDRESS:

DATE OF EXAMINATION:

OBSTERTIC SCORE:

HISTORY OF PRESENTING ILLNESS:

MENSTRUAL HISTORY:

MARITAL HISTORY:

OBSTETRICS HISTORY:

PAST HISTORY:

FAMILY HISTORY:

GENERAL EXAMINATION:

HEIGHT: WEIGHT:

RESPIRATORY RATE:

PULSE RATE: BLOOD PRESSURE:

TEMPERATURE:

PALLOR: PEDAL EDEMA:

ICTERUS:

BREAST: THYROID:

SYSTEMIC EXAMINATION

CVS: RESPIRATORY SYSTEM:

PER ABDOMEN:

PER VAGINAL EXAMINATION:

PROVISIONAL DIAGNOSIS:

USG FINDINGS

CONSENT FORM

I Mr/Mrs hereby volunteer to participate in the study

"“COMPARATIVE STUDY OF EXTRA AMNIOTIC SALINE



INDUCTION OF LABOUR”. I was explained about the nature of the

study by the doctor, knowing which I fully give my consent to participate

in this study. I also give consent to take clinical photographs for the

purpose of the study.

Date :

Place :

Signature of the Patient

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KEY TO MASTER CHART

S.N

o

Nam

e

IP.N

o

Age

Gra

vida

US

IFI

BS

0

BS

6

BS

12

BS

18

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Oxy ILI

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NO

Int.

MD

Int.

PPH

Int.

Pyr

Post

Sep

1 Chitra 67582 21 1 38 2 2 6 10 - 0 0 9 12 0 - Good 0 0 0 02 Menaka 89765 19 1 41 1 3 5 11 - 0 0 8 11 1 0 Good 0 0 0 03 Anushya 85623 24 2 41 1 2 6 6 8 0 1 7 13 1 1 Adm 0 0 0 04 Sathya 86237 22 1 39 2 3 7 11 - 0 0 6 10 0 0 Good 0 0 0 05 Priya 89385 26 2 37 3 2 7 7 - 0 1 9 15 1 0 Good 0 1 0 06 Krithiga 68251 22 1 38 5 2 8 10 - 0 1 8 13 0 0 Adm 0 0 0 07 Geetha 73279 20 1 39 2 3 9 8 - 0 0 9 14 0 0 Good 0 0 0 08 Meena 56821 23 2 37 3 2 6 6 - 0 1 9 18 1 1 Good 0 0 0 09 Anjali 61521 27 3 38 2 3 5 5 - 0 1 13 20 0 0 Good 0 0 1 0

10 Madhu 63991 25 3 38 3 3 6 6 - 0 1 11 20 2 0 Good 0 0 0 011 Keerthana 57892 30 1 40 1 2 8 8 - 0 0 8 15 0 0 Adm 0 0 0 012 Mylathal 63589 33 4 36 5 3 5 5 - 0 1 13 18 0 0 Good 0 0 0 013 Rammayi 58960 37 2 41 1 2 6 6 - 0 1 14 16 3 0 Good 0 0 0 014 Devi 67432 20 1 38 4 2 5 8 - 0 0 9 13 1 0 Good 1 0 0 015 Fathima 63740 24 3 37 2 3 6 6 - 0 1 12 18 0 0 Good 0 0 0 016 Jaya 70452 26 2 38 3 2 5 5 - 0 1 14 20 3 0 Good 0 0 0 017 Gowri 68466 28 1 41 1 2 8 10 - 0 0 7 10 0 0 Good 0 0 0 018 Bhagyalakshmi 62538 21 1 39 3 2 9 9 - 0 0 8 14 0 0 Good 1 0 0 019 Chandrakala 67753 23 1 36 5 2 8 8 - 0 1 6.5 16 1 0 Adm 0 0 0 020 Dhanalakshmi 63997 26 2 40 1 3 6 7 - 0 1 10 14 2 0 Good 0 0 0 121 Seetha 64308 25 2 38 4 2 6 7 - 0 1 9 18 0 0 Good 0 0 0 022 Kavitha 64270 21 3 41 1 3 7 7 - 0 1 11 16 0 0 Good 0 0 0 023 Poornima 56848 28 1 38 2 2 8 10 - 0 0 6 12 0 0 Good 0 0 0 024 Divya 62960 22 4 38 3 3 6 6 - 0 1 12 18 2 0 Good 0 0 0 025 Lakshmi 57265 26 2 37 3 2 6 6 - 0 1 13 18 0 0 Good 0 0 1 0

MASTER CHART

26 Preethi 43226 23 1 41 1 1 7 11 - 0 0 6 14 1 0 Adm 0 0 0 027 Shanthi 41063 20 3 38 4 3 5 6 - 0 1 12 20 3 0 Good 0 0 0 028 Jeeva 32475 32 2 37 3 3 5 6 - 0 1 10 19 0 0 Good 0 0 0 029 Gomathi 35162 23 1 40 1 2 7 10 - 0 0 6.5 15 2 0 Good 1 0 0 030 Saranaya 62831 29 3 38 4 3 4 5 - 0 1 15 20 0 0 Good 0 0 0 031 Muniyammal 64522 25 2 37 2 2 5 6 - 0 1 11 18 1 1 Good 0 0 0 032 Kaleeshwari 93286 29 1 41 1 2 8 10 - 0 0 6 15 0 0 Good 0 0 0 033 Sowmya 94360 21 2 36 3 3 6 7 - 0 1 14 14 0 0 Good 0 0 0 034 Sivashakthi 86253 30 2 40 1 2 6 8 - 0 0 9 16 1 1 Good 0 0 0 035 Nandhini 32351 19 1 40 1 2 6 9 - 0 0 10 16 0 0 Good 0 1 0 036 Radha 45298 27 2 38 3 3 5 5 - 0 1 14 18 0 0 Good 0 0 0 037 Sunitha 42063 24 1 39 2 2 6 8 - 0 0 8 15 0 0 Good 0 0 0 038 Ameena 57061 28 3 41 1 3 5 5 - 0 1 15 20 1 0 Good 0 0 0 039 Sandhiya 95896 23 2 38 4 2 6 8 - 0 0 10 19 0 0 Good 0 0 0 040 Thavamani 90157 25 1 40 1 2 8 11 - 0 0 7 14 3 0 Good 0 0 0 041 Sudha 89753 31 2 38 2 3 5 12 - 0 0 8 10 0 0 Good 0 1 0 042 Nilofer 75625 20 1 37 3 2 6 6 - 0 1 11 16 3 0 Good 0 0 0 043 Anitha 73204 22 1 40 1 2 8 11 - 0 0 7 19 1 1 Good 0 0 0 044 Jasmine 87529 24 3 38 5 3 5 6 - 0 1 12 18 0 0 Good 1 0 0 145 Nithya 35941 28 1 39 1 2 6 12 - 0 0 6 14 2 0 Good 0 0 0 046 Sindhu 74250 29 2 41 1 3 5 9 - 0 0 8 19 3 0 Good 0 0 0 047 Punitha 86635 28 2 39 3 2 4 6 - 0 1 12 20 0 0 Good 0 0 0 048 Pavithra 25739 25 1 40 1 2 6 9 - 0 0 11 18 1 0 Adm 0 0 0 049 Bhavya 30263 27 2 38 4 3 4 6 - 0 0 14 17 0 0 Good 0 1 0 050 Elamathy 63257 22 1 40 1 2 6 12 - 0 0 6 12 1 0 Good 0 0 0 0

S.N

o

Nam

e

IP.N

o

Age

Gra

vida

US

IFI

BS 0

BS 6

BS 1

2

BS 1

8

MO

I

Oxy ILI

IDI

MO

D

Ind-

CS

NO

Int.

MD

Int.

PPH

Int.

Pyr

Post

Sep

1 Rani 42561 20 1 40 1 2 5 8 0 1 1 14 18 0 good 0 0 0 0

2 Swetha 32620 26 1 36 2 2 6 9 12 1 0 12 20 0 good 0 0 0 0

3 Saranya 41575 28 2 40 1 2 6 8 1 1 8 15 1 0 good 0 0 0 0

4 Akila 56738 22 3 38 3 2 7 9 1 1 9 16 0 good 0 1 0 0

5 Bhuvana 54022 36 4 38 4 3 6 9 1 1 7 15 0 good 0 0 0 0

6 Thilaka 23842 29 3 41 1 3 6 8 1 0 9 17 1 0 good 0 0 1 0

7 Varalakshmi 38035 32 2 39 2 3 7 10 1 1 9 18 0 1 good 1 0 0 0

8 Yalini 20846 21 1 41 1 2 5 9 1 1 13 22 1 adm 0 0 0 0

9 Bhavana 34283 38 2 39 3 2 7 8 1 0 10 18 0 good 0 0 0 0

10 Seetha 36848 27 3 37 2 3 6 9 1 0 10 15 0 1 good 0 0 0 0

11 Gokila 54627 24 1 40 1 2 5 8 1 1 12 21 1 adm 0 0 0 0

12 Amala 38646 39 4 39 4 3 6 9 1 0 9 16 2 good 0 0 0 0

13 Punitha 49560 23 2 41 1 2 7 8 1 1 8 18 0 0 good 0 0 0 0

14 Ranjitha 49428 30 3 38 2 3 6 9 1 0 9 15 1 adm 0 1 0 0

15 Sathya 58736 34 1 41 1 2 5 8 12 1 1 13 22 0 good 0 0 0 0

16 Preetha 48269 26 2 39 3 3 6 9 1 1 10 18 3 good 0 0 0 1

17 Priya 43097 20 3 40 1 2 6 10 1 0 9 16 0 good 0 0 0 0

18 Aruna 89675 27 2 38 2 2 7 10 1 1 10 18 0 good 0 0 1 0

19 Anitha 86758 22 1 41 1 1 6 9 1 1 12 20 0 1 good 0 0 0 0

20 Priyanka 68344 28 1 39 3 2 5 8 1 1 11 21 1 good 0 0 0 0

21 Chandra 67489 21 2 36 5 3 7 10 1 1 10 18 2 adm 0 0 0 0

22 Kaviya 64038 23 1 40 1 2 6 8 1 0 12 20 3 0 good 1 0 0 0

23 Hema 59879 36 3 38 2 3 6 8 12 1 1 9 15 1 good 0 0 0 0

24 Sheela 56841 19 1 41 1 2 6 8 1 0 10 19 0 good 0 0 0 0

25 Vasantha 39756 24 2 39 4 2 5 9 1 0 9 18 0 good 0 0 0 0

ER CHART MASTER

26 Kavitha 49274 29 2 41 1 3 6 10 1 1 8 16 0 1 adm 0 0 0 0

27 Renuka 37156 22 1 39 3 2 5 8 1 1 12 20 1 good 0 0 0 0

28 Pavithra 59689 25 1 40 1 2 5 9 1 0 13 19 3 good 0 0 0 0

29 Ilakiya 39256 32 3 38 2 2 6 8 1 0 10 18 2 good 0 0 0 0

30 Fathima 78372 34 4 39 3 3 7 9 1 1 9 16 1 2 good 0 0 0 0

31 Anjali 79458 19 1 40 1 2 6 8 1 0 14 20 0 good 1 0 0 0

32 Sangeetha 46582 25 3 39 2 3 7 9 1 1 10 18 0 good 0 1 0 0

33 Sunitha 49283 22 2 41 1 2 6 8 12 1 0 9 19 1 0 good 0 0 0 0

34 Surya 65826 27 3 38 3 2 8 9 1 1 8 16 3 good 0 0 1 0

35 Arpitha 89647 20 2 41 1 2 6 9 1 1 8 18 1 0 good 0 0 0 0

36 Aruna 85731 25 1 39 2 2 8 10 1 1 11 19 2 good 0 0 0 0

37 Jayasudha 96528 28 3 38 4 3 7 10 1 0 7.5 16 0 good 0 0 0 0

38 Ramayee 93842 21 1 40 1 2 6 9 1 1 12 22 1 1 good 0 0 0 0

39 Vanitha 65639 30 2 37 2 2 7 10 1 1 8 16 3 good 1 0 0 1

40 Krithika 53741 24 3 39 3 3 6 11 1 0 9 15 0 good 0 0 0 0

41 Deivasudha 56748 29 1 41 1 2 7 9 1 1 10 19 1 0 adm 0 0 0 0

42 Janani 93743 20 2 38 3 3 7 10 1 1 8 16 0 good 0 0 0 0

43 Padma 82058 23 3 39 4 3 6 9 1 0 8 15 0 good 0 1 0 0

44 Gowri 72583 30 1 36 5 2 8 8 11 1 1 10 20 0 good 0 0 0 0

45 Srilakshmi 82746 23 2 40 1 2 6 9 1 0 9 17 1 2 good 0 0 1 0

46 vidhya 95842 22 3 38 2 3 7 9 1 1 8 15 2 good 0 0 0 0

47 Chitra 97537 29 2 39 2 2 5 10 1 1 7 18 3 good 0 0 0 0

48 Saranya 89359 19 2 41 1 3 6 9 1 0 8 18 1 0 good 0 0 0 0

49 Nithiya 42673 25 3 38 2 3 6 10 1 0 9 16 3 good 0 0 0 0

50 Selvi 84254 21 1 40 1 2 5 8 10 1 1 12 22 0 good 0 0 0 0

comparative study of extra amniotic saline

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