Emergency Obstetric and Neonatal Care: The EmONC Trial

Not Applicable

Completed

• Conditions: Stillbirth and Neonatal Mortality; Maternal Morbidity and Mortality
• Interventions: Behavioral: Community Mobilization, HBLSS and facility improvement

• Registration Number: NCT01073488
• Lead Sponsor: NICHD Global Network for Women's and Children's Health

Brief Summary

The objective of this cluster randomized controlled trial is to reduce maternal and neonatal mortality by increasing access to and improving the quality of obstetric and neonatal care for pregnant women in study clusters. It is hypothesized that a 25% reduction in \>28 week or \>1000 gram stillbirth and 7-day neonatal mortality will be achieved in the intervention clusters by a multifaceted Emergency Obstetric Neonatal Care (EmONC) package that will be introduced by an EmONC team.

Detailed Description

Maternal death, stillbirth, early neonatal death, and obstetric fistula are among the most devastating adverse outcomes of pregnancy. Existing interventions could avert the majority of maternal and neonatal deaths; however, those women at greatest risk are least likely to have access to interventions delivered through the formal health care system. In many developing countries, most deliveries in rural areas and a significant number in urban areas are conducted at home without skilled attendance, circumstances which pose a high risk for both mothers and their neonates. The EmONC trial is designed to evaluate a comprehensive intervention encompassing community mobilization to establish and sustain mechanisms of transport and payment and to drive client-oriented emergency obstetrical and neonatal care. The intervention includes teaching recognition of prolonged labor, infection, preeclampsia and hemorrhage, and the use of appropriate stabilization methods by all community birth attendants. In addition, poor access to quality emergency obstetric and neonatal care in a sustainable manner will be addressed. To evaluate the effectiveness of this approach, a cluster-randomized trial is required to assess whether Cluster EmONC teams can work with the community and health care system to reduce adverse pregnancy outcomes in diverse settings where the majority of deliveries occur at home or at a health clinic with few or no available EmONC interventions. To accomplish the intervention, a train-the-trainer approach will be used. Master trainers will facilitate central and regional training sessions for Country trainers organized around the areas of community mobilization; birth attendant skills; and EmONC referral facility improvements. The Country trainers will then support training and related activities in the intervention clusters, predominantly focusing on these three areas. The study population includes pregnant women (and their neonates) living and delivering in the 108 study clusters. The study clusters are largely rural, geographically distinct communities, each of which have approximately 300 annual deliveries. The women will be enrolled at or after 20 weeks gestation and followed to 42 days post delivery. The total duration of the trial will be 24 months.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-02-21
• Study First Submitted QC: 2010-02-21
• Study First Posted: 2010-02-23
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-15
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 267181

Inclusion Criteria

1. Pregnant women living in and/or delivering within the study cluster
2. Consent provided

Exclusion Criteria

Eligible pregnant women who do not consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMONC: Community mobilization, HBLSS and Facility Improvement	Community Mobilization, HBLSS and facility improvement	The intervention group received training in community mobilization activities, Home Based Life Saving Skills (HBLSS) and facility improvement.

Primary Outcome Measures

Name	Time	Method
Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate	7 days post delivery

Secondary Outcome Measures

Name	Time	Method
Rates of mothers transported to a referral hospital.	42 days post delivery
Maternal morbidity rates	42 days post delivery
Stillbirth rate	Delivery
7-day neonatal mortality rate	7 days post delivery
Rates of neonates/infants transported to a referral hospital	42 days post delivery
28-day neonatal mortality rate	28 days post delivery
Maternal mortality rate	42 days post delivery

Trial Locations

Locations (7)

Jawaharlal Nehru Medical College; 🇮🇳 Belgaum, India

University of Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Indira Gandhi Government Medical College; 🇮🇳 Nagpur, India

Moi University School of Medicine; 🇰🇪 Eldoret, Kenya

University Teaching Hospital; 🇿🇲 Lusaka, Zambia

IMSALUD / San Carlos University; 🇬🇹 Guatemala City, Guatemala

The Aga Khan University; 🇵🇰 Karachi, Pakistan