Emergency Obstetric and Neonatal Care: The EmONC Trial

Overview

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.

Full Title of Study: “Evaluation of an Emergency Obstetric and Neonatal Care (EmONC) Intervention Package to Reduce Adverse Pregnancy Outcomes in Low Resource Settings (The EmONC Trial)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

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.

Interventions

  • Behavioral: Community Mobilization, HBLSS and facility improvement
    • Mobilization of the community, with special emphasis on pregnant women and their families, to identify resources and solutions to improve maternal and neonatal mortality, home-based life savings skills (HBLSS) for community birth attendants and facility improvement activities.

Arms, Groups and Cohorts

  • Experimental: EMONC: Community mobilization, HBLSS and Facility Improvement
    • The intervention group received training in community mobilization activities, Home Based Life Saving Skills (HBLSS) and facility improvement.
  • No Intervention: Control
    • The control group did not receive an intervention, but collected outcome data through a baseline maternal/newborn birth registry.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • NICHD Global Network for Women’s and Children’s Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robert Goldenberg, MD, Principal Investigator, Drexel University College of Medicine

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