MaMoni Project Brief: Implementing National Guidelines on ...

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1 Project Brief USAID’s MaMoni HSS Project Overview Bangladesh is one of 12 countries that bear the largest global burden of neonatal mortality 1 . The majority of newborn deaths are caused by intrapartum complications, severe infection, and prematurity. Preterm delivery (birth before 37 weeks of pregnancy are completed) occurs in 14 percent of pregnancies in Bangladesh. This equates to more than 400,000 preterm newborns each year 2 . Overall, complications of preterm birth contribute to nearly one-third of newborn mortality in the country 3 . To accelerate the reduction of newborn mortality, the Government of Bangladesh adopted a set of evidence-based newborn interventions that were announced in 2013. The aim was to address the three primary causes of newborn death. The adopted newborn interventions included the use of antenatal corticosteroids (ACS) for preterm delivery. Under the leadership of the Ministry of Health and Family Welfare (MOH&FW), a national-level newborn health community of experts developed ACS guidelines and a package of newborn care tools. The United States Agency for International Development (USAID)-funded MaMoni Health Systems Strengthening (MaMoni HSS) project provided support to the MOH&FW for the early implementation of ACS for improving outcomes of preterm newborns at district-level facilities. Implementing National Guidelines on Use of Antenatal Corticosteroids to Prevent Complications of Prematurity A woman who received antenatal corticosteroid at Habiganj District Hospital with her newborn. Photo by: Syed Ahmed/Save the Children September 2018

Transcript of MaMoni Project Brief: Implementing National Guidelines on ...

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Project Brief USAID’s MaMoni HSS Project

Overview

Bangladesh is one of 12 countries that bear the largest

global burden of neonatal mortality1. The majority of

newborn deaths are caused by intrapartum complications,

severe infection, and prematurity. Preterm delivery (birth

before 37 weeks of pregnancy are completed) occurs in 14

percent of pregnancies in Bangladesh. This equates to

more than 400,000 preterm newborns each year2. Overall,

complications of preterm birth contribute to nearly one-third

of newborn mortality in the country3.

To accelerate the reduction of newborn mortality, the

Government of Bangladesh adopted a set of

evidence-based newborn interventions that were

announced in 2013. The aim was to address the three

primary causes of newborn death. The adopted newborn

interventions included the use of antenatal corticosteroids

(ACS) for preterm delivery.

Under the leadership of the Ministry of Health and Family

Welfare (MOH&FW), a national-level newborn health

community of experts developed ACS guidelines and a

package of newborn care tools. The United States Agency

for International Development (USAID)-funded MaMoni

Health Systems Strengthening (MaMoni HSS) project

provided support to the MOH&FW for the early

implementation of ACS for improving outcomes of preterm

newborns at district-level facilities.

Implementing National Guidelines on Use of Antenatal Corticosteroids

to Prevent Complications of Prematurity

A woman who received antenatal corticosteroid at Habiganj District Hospital with her newborn.

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Evidence

Globally, ACS has been used since the early 1970s to

reduce the incidence of respiratory distress syndrome in

preterm infants. Studies have shown that the use of ACS

when a woman is between 24 and 34 weeks of gestation

and delivers within a week of receiving the drug is

associated with a 31 percent reduction in neonatal

mortality4–7. However, this effect was not observed in a

recent multicountry study in low- and middle-income

countries, possibly due to a lack of high-quality newborn

intensive care8. In 2015, the World Health Organization

(WHO) released recommendations on interventions to

improve preterm birth outcomes inclusive of ACS,

antibiotics for preterm labor, kangaroo mother care,

continuous positive airway pressure, surfactant, and safe

oxygen use9.

National Guidelines and Tools Bangladesh’s national guidelines on use of ACS in

Threatened Preterm Deliveries to Reduce Neonatal

Mortality and Morbidities 10, were also released in 2015.

They follow the WHO recommendations (see box) on the

necessary preconditions for safe and efficacious use of

ACS.

The ACS protocol in the national guidelines is as follows:

“The clinical conditions under which antenatal

corticosteroid administration has been investigated are

those associated with threatened or inevitable preterm

delivery.

These include:

1. Preterm labor

2. Preterm premature rupture of membranes (pPROM)

3. Severe Pre-eclampsia/Eclampsia

4. Antepartum Hemorrhage (APH)

Any of the conditions above observed between 24–34

(34+6) weeks of gestational age should prompt a provider

to initiate administration of ACS.”

Figure 1: Antenatal corticosteroids pictorial algorithm

from the Bangladesh Comprehensive Newborn Care

Package (2015)

Preconditions for Antenatal Corticosteroids

Introduction

Gestational age can be accurately assessed.

Preterm birth is considered imminent.

There is no clinical evidence of maternal infection.

Adequate childbirth care is available.

Preterm newborns can receive adequate care for

complications if needed (including resuscitation,

thermal care, feeding support, infection treatment,

and safe oxygen use).

The What and Why of Antenatal Corticosteroids for Preterm Delivery7,9

Respiratory distress syndrome (RDS) is the most common cause of death among babies born before 34 weeks of

gestation.

Use of ACS for women with threatened preterm delivery reduces the severity of and mortality associated with RDS

among these newborns.

Dexamethasone sodium phosphate and betamethasone acetate + phosphate are the two efficacious and safe

corticosteroids for use for threatened or inevitable preterm delivery.

Dexamethasone, listed in the World Health Organization is (WHO) essential medicines list, is inexpensive and widely

available in Bangladesh.

According to WHO recommendations, ACS should be administered to eligible pregnant women in health facilities

that meet certain preconditions for maternal and newborn care.

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National guidelines exist for the specific management of

each one of the abovementioned clinical conditions. The

recommended ACS dosage as per the national guidelines is

dexamethasone 6 mg every 12 hours (for a maximum of

four doses) or dexamethasone 12 mg every 24 hours (for a

maximum of two doses).

A flowchart for providers is included in the ACS guidelines to

assist them in determining whether a woman is eligible to

receive ACS. In addition, the nationally endorsed

Comprehensive Newborn Care Package (CNCP) was

developed to support implementation of this and the other

priority newborn interventions. A pictorial algorithm (Figure

1) for ACS administration was included in the CNCP.

Support Provided By MaMoni HSS to the

MOH&FW Site Preparation

Three district hospitals were selected for the ACS

intervention. Initially, the intervention was introduced in

Habiganj and Noakhali district hospitals. Later, it was

introduced in Lakshmipur District Hospital. To ensure

newborn care, MaMoni HSS supported the setup of special

care newborn units (SCANUs) and kangaroo mother care

units at each facility. These inputs are described in

separate project briefs. Each hospital had an obstetrician-

gynecologist who provided leadership to ensure the

preconditions for ACS were met.

Provider Capacity-Building

The project mobilized technical experts from the Obstetrical

and Gynaecological Society of Bangladesh and

Bangabandhu Sheikh Mujib Medical University (BSMMU) to

train providers. Thirty-three doctors and 11 nurses from the

initial two hospitals were trained in accordance with the

national ACS guidelines and the CNCP. The training focused

on appropriate screening of cases and use of a decision

algorithm to accurately determine gestational age and

assess the signs of imminent birth. It employed hands-on

demonstration of the necessary technical competencies.

After the training participants received key job aids to assist

them in their practice. The trainers visited each hospital

following the training to provide on-the-job coaching and

supervision. Follow-up visits included brief refresher

trainings.

Documentation and Reporting

For recordkeeping of services, efforts were made to utilize

existing emergency obstetric care registers. Providers

documented information on ACS administration in the

“remarks” column. Other relevant information (i.e.,

gestational age, imminent birth sign[s], ACS dose, and

delivery outcomes) was systematically collected in a

supplementary form and summarized monthly for MaMoni

HSS.

The emergency obstetric care register was later updated at

the national level to capture gestational age. MaMoni HSS

provided support to ensure its availability, and providers

were trained on its use.

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Results from Initial Implementation In mid-2017 and early 2018, MaMoni HSS conducted a

review of the ACS intervention to reflect upon its

implementation experience in Habiganj and Noakhali

district hospitals. In selecting these two hospitals as the

focus of this analysis, consideration was given to the

relative maturity of the project’s intervention across the

three ACS sites. Data collection consisted of a rapid facility

readiness assessment, review of data of pregnant women

who received ACS, and interviews with providers.

Facility Readiness

The facility readiness assessment revealed that both

hospitals had functional SCANUs and dedicated spaces for

kangaroo mother care. The available SCANU equipment

included radiant warmers to provide thermal care for

unstable, low-birthweight babies, a phototherapy machine,

and essentials (such as a bag and mask) for newborn

resuscitation and safe oxygen use. They also had safe

resting places for mothers with babies admitted to the

SCANU.

The majority of the job aids provided by the project were

available on site during the assessment. These included the

national ACS guidelines, a gestational age calendar,

protocols for the management of pregnancy complications

(eclampsia, APH, and pPROM), a supplementary data

collection form, and the action plan for ACS administration

(Figure 1).

Case Review of Pregnant Women Who Received ACS From January 2016–December 2017, 633 pregnant

women received ACS at Habiganj and Noakhali district

hospitals. Among them, 315 were seen in 2016 and 318 in

2017. About two-thirds were between 20 and 29 years old,

and over 90 percent had at least one antenatal care

consultation during pregnancy.

Figure 2. Antenatal corticosteroid recipients by gestational age (n=623)

Among the women who received ACS, 73 percent were

between 24 and 34 weeks of gestation (Figure 2). The

largest grouping of ACS recipients who fell outside this

window were between 35 and 37 weeks of gestation.

Overall, 425 (67%) were between 24 and 34 weeks of

gestation and presented with a sign of imminent birth.

The segregation of pregnant women who received ACS by

eligibility criteria is demonstrated in Figure 3.

Completeness of data was a significant challenge.

Complete data on methods used for gestational age

assessment was only available in 2017. Among the 318

pregnant women who received ACS that year, gestational

age was determined by last menstrual period (LMP) and

uterine height measurement for all cases. In addition, an

ultrasound was done for 312 cases (98% of ACS

recipients).

Among the 633 ACS recipients, 70 (11%) did not have a

record of a clinical condition indicative of imminent birth.

The most common condition recorded was preterm

prelabor rupture of membranes (69%). This was followed

by cervical effacement and dilation (19%). Severe pre-

eclampsia/eclampsia and antenatal hemorrhage affected

7 percent of women each (Table 1).

Providers’ Perspectives

Five providers (three doctors and two nurses) were

interviewed about their practices in determining eligibility

for and administering ACS. In interviews, providers

described primarily basing their determination of

gestational age on the date of women’s LMP, though they

also use the other two methods (uterine height

measurement and ultrasound). If a woman has trouble

recollecting the date of her LMP, she is asked to

associate it with a festival or harvest period. It is more

common for women with fewer antenatal visits to struggle

with recollecting their LMP, as demonstrated by the

following quotation:

“Most of the women do not take the complete ANC

(minimum four visits). Very few of them take only 1 or 2

ANC and can recall LMP.”

-Nurse, Noakhali District Hospital

Most providers reported that all eligible patients receive

an ACS course. However, some eligible women with

advanced labor do not receive ACS due to lack of time.

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73

24

2

<24 weeks (01%) 24—34 weeks (73%) 35—37 weeks (24%) >37 weeks (02%)

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Figure 3. Flowchart of pregnant women who received antenatal corticosteroids by eligibility criteria (Habiganj

and Noakhali, 2016 and 2017)

Across interviews, providers described staffing shortages

as a challenge. They explained that more nurses and

doctors are needed to provide better quality of care for

preterm babies.

Limitations of This Analysis

There were some limitations to this analysis. One of these

was incomplete documentation of services in the

emergency obstetric care registers. Samples of 2 months

of register data revealed that gestational age was only

captured for 38 percent of all pregnant women seen. This

made it impossible to assess how many eligible women

did not receive ACS. Further, information about birth

outcomes and management of sick newborns was only

available for a small proportion of cases. The project is

working to improve this.

Key Lessons This brief is intended to provide public health

professionals with a descriptive snapshot of the early ACS

implementation experience in a secondary-level care

setting in Bangladesh. Some key lessons learned are as

follows:

Adherence to National ACS Guidelines

While two-thirds of ACS recipients met the eligibility

criteria as per national guidelines, prescribing ACS

to ineligible pregnant women was also observed. Thus,

the ACS eligibility criteria described in the national ACS

guidelines are not being adhered to with regularity.

Completeness of Service Records

There were also gaps in the availability of relevant data.

Completeness and accuracy of service documentation, as

well as actionable use of data, were not in practice during

the period selected for review. This prevented

assessment of whether eligible patients were missed,

how maternal infection was monitored and treated, care

provided to preterm newborns, and newborn outcomes.

ACS Dose Packaging Injectable dexamethasone is only available locally in 5

mg/1 mL ampules, while the national guidelines specify

dose sizes of either 6 mg or 12 mg. This makes the

calculation of accurate dosage challenging and raises

questions about injection safety and product waste. This

could be addressed by the Directorate General of Drug

Administration, ensuring that pharmaceutical companies

produce dose convenient packages.

Received

antenatal

corticosteroids:

633

Gestational age

Recorded: 622 Within 24–34

weeks: 456

Signs of

imminent birth

recorded: 425

Beyond the

gestational age

range: 166 Not recorded: 10

Signs of

imminent birth

not recorded: 31

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SIGNS OF IMMINENT PRETERM BIRTH NUMBER AND PERCENTAGE OF ANTENATAL

CORTICOSTEROID RECIPENTS

Preterm prelabor rupture of membranes 439 69%

Cervical effacement and dilation 118 19%

Severe pre-eclampsia/eclampsia 46 7%

Antenatal hemorrhage 42 7%

None 70 11%

Table 1. Distribution of signs of imminent preterm birth (n=633; all antenatal corticosteroid patients

2016 and 2017)

Conclusion Overall, the key readiness elements and experience for scaling up ACS use in district (secondary)-level facilities are in

place. ACS guidelines and implementation tools, affordability and availability of dexamethasone, and protocols for the

management of pregnancy and delivery complications are already part of the Bangladesh health system. Methods for

reporting gestational age, pregnancy complication, and ACS administration are integrated into the health management

information system. However, there is a need for stronger documentation of services, use of data for program monitoring,

and the provision of regular feedback. With higher-quality data, more comprehensive analysis of ACS use could be done,

which could assist in strengthening both service quality and the evidence base around ACS use in low-resource settings.

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The MaMoni HSS is a 5-year project of United States Agency for

International Development under the global Maternal and Child

Health Integrated Program. The focus of this project is strengthening

the systems and standards for maternal, newborn, and child health,

family planning, and nutrition to contribute to declines in maternal,

newborn, and child mortality in Bangladesh. The project supports the

Ministry of Health and Family Welfare to introduce and leverage

support for scale-up of evidence-based practices already

acknowledged in Bangladesh.

MaMoni HSS is primed by Jhpiego in partnership with Save the

Children, John Snow Inc., and Johns Hopkins University/Institute for

International Programs, with national partners icddr,b; Dnet; and

Bangabandhu Sheikh Mujib Medical University; and six local

nongovernmental organizations.

The project covers 40 upazilas in six districts and serves around 12.2 million people. The six focus districts are

Habiganj, Lakshmipur, Jhalokati, Noakhali, Pirojpur, and Bhola.

Anna Williams, Sabbir Ahmed, Marufa Khan, Sanjida Alam, Munia Islam, Joseph Johnson, Imteaz Mannan, Uzma Syed, Joby

George, Iftekher Rashid

This work would not have been possible without the technical leadership of members of the MOH&FW, the National

Technical Working Committee for Newborn Health under the National Core Committee – Neonatal Health, USAID, the

Obstetric and Gynaecological Society of Bangladesh, BSMMU, the Saving Newborn Lives program, the dedicated staff of

Lakshmipur and Noakhali district hospitals, and the MaMoni HSS district teams.

About MaMoni Health Systems Strengthening (MaMoni HSS) Project

Contact Us

______________________________

MaMoni Health Systems Strengthening

(MaMoni HSS) Project

Save the Children

Save the Children Hs No CWN (A)

35, Road 43, Gulshan 2, Dhaka

1212, Bangladesh

Email:

[email protected]

Web: http://www.mamoni.info

Authors

Acknowledgments

Disclaimer: This brief is made possible by the support of the American people through the United States Agency for International Development (USAID).

The contents are the sole responsibility of USAID’s MaMoni HSS Project and do not necessarily reflect the views of USAID or the United States

Government.

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6736(14)61698-6.

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knowledge of the impact of antenatal corticosteroids on preterm birth outcomes in low-middle income countries.

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Morbidity and Mortality. London: RCOG.

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8. Althabe F, Belizan JM, McClure EM, et al. 2015. A population-based, multifaceted strategy to implement antenatal

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