Evaluation of a cluster-randomized controlled trial of a package of community-based maternal and newborn interventions in Mirzapur, Bangladesh

Gary L Darmstadt, Yoonjoung Choi, Shams E Arifeen, Sanwarul Bari, Syed M Rahman, Ishtiaq Mannan, Habibur Rahman Seraji, Peter J Winch, Samir K Saha, A S M Nawshad Uddin Ahmed, Saifuddin Ahmed, Nazma Begum, Anne C C Lee, Robert E Black, Mathuram Santosham, Derrick Crook, Abdullah H Baqui, Bangladesh Projahnmo-2 Mirzapur Study Group, Gary L Darmstadt, Yoonjoung Choi, Shams E Arifeen, Sanwarul Bari, Syed M Rahman, Ishtiaq Mannan, Habibur Rahman Seraji, Peter J Winch, Samir K Saha, A S M Nawshad Uddin Ahmed, Saifuddin Ahmed, Nazma Begum, Anne C C Lee, Robert E Black, Mathuram Santosham, Derrick Crook, Abdullah H Baqui, Bangladesh Projahnmo-2 Mirzapur Study Group

Abstract

Background: To evaluate a delivery strategy for newborn interventions in rural Bangladesh.

Methods: A cluster-randomized controlled trial was conducted in Mirzapur, Bangladesh. Twelve unions were randomized to intervention or comparison arm. All women of reproductive age were eligible to participate. In the intervention arm, community health workers identified pregnant women; made two antenatal home visits to promote birth and newborn care preparedness; made four postnatal home visits to negotiate preventive care practices and to assess newborns for illness; and referred sick neonates to a hospital and facilitated compliance. Primary outcome measures were antenatal and immediate newborn care behaviours, knowledge of danger signs, care seeking for neonatal complications, and neonatal mortality.

Findings: A total of 4616 and 5241 live births were recorded from 9987 and 11153 participants in the intervention and comparison arm, respectively. High coverage of antenatal (91% visited twice) and postnatal (69% visited on days 0 or 1) home visitations was achieved. Indicators of care practices and knowledge of maternal and neonatal danger signs improved. Adjusted mortality hazard ratio in the intervention arm, compared to the comparison arm, was 1.02 (95% CI: 0.80-1.30) at baseline and 0.87 (95% CI: 0.68-1.12) at endline. Primary causes of death were birth asphyxia (49%) and prematurity (26%). No adverse events associated with interventions were reported.

Conclusion: Lack of evidence for mortality impact despite high program coverage and quality assurance of implementation, and improvements in targeted newborn care practices suggests the intervention did not adequately address risk factors for mortality. The level and cause-structure of neonatal mortality in the local population must be considered in developing interventions. Programs must ensure skilled care during childbirth, including management of birth asphyxia and prematurity, and curative postnatal care during the first two days of life, in addition to essential newborn care and infection prevention and management.

Trial registration: Clinicaltrials.gov NCT00198627.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1. Distribution of study unions (clusters),…
Figure 1. Distribution of study unions (clusters), Mirzapur sub-district, Tangail district, Bangladesh.
Red circle: Union Head Quarter. Star: Kumudini Hospital. Light blue line: River/Beel. Pink shade: Intervention Area, Purple shade: Comparison Area.
Figure 2. Trial profile for measurement of…
Figure 2. Trial profile for measurement of neonatal mortality.
*Participants are women of reproductive age (15–49).

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