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Completed

NCT Number: NCT01073488

Emergency Obstetric and Neonatal Care: The EmONC Trial

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Buenos Aires, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women living in and/or delivering within the study cluster
  • Consent provided

Exclusion criteria

Eligible pregnant women who do not consent

Treatment and study plan

Community Mobilization, HBLSS and facility improvement

Behavioral

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.

Other names: CM

Primary outcomes

  1. Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate

    Time frame: 7 days post delivery

Secondary outcomes

  1. Maternal mortality rate

    Time frame: 42 days post delivery

  2. Maternal morbidity rates

    Time frame: 42 days post delivery

  3. Stillbirth rate

    Time frame: Delivery

  4. 7-day neonatal mortality rate

    Time frame: 7 days post delivery

  5. 28-day neonatal mortality rate

    Time frame: 28 days post delivery

  6. Rates of mothers transported to a referral hospital.

    Time frame: 42 days post delivery

  7. Rates of neonates/infants transported to a referral hospital

    Time frame: 42 days post delivery

Sponsors and collaborators

Lead sponsor

NICHD Global Network for Women's and Children's Health

Network

Registry information

Official study title

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

Acronym: EmONC

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 23, 2010
Registry last updated
Nov 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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