Emergency Obstetric and Neonatal Care: The EmONC Trial

NCT ID: NCT01073488

Last Updated: 2013-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 267181 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-10-31

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.

Conditions

Maternal Morbidity and Mortality; Stillbirth and Neonatal Mortality

Keywords

Pregnancy; Maternal child health; Developing countries; Stillbirth; Neonatal mortality; Maternal mortality; Community intervention; Community mobilization; Home-based Life Saving Skills

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Community Mobilization, HBLSS and facility improvement

Intervention Type: 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.

Control

The control group did not receive an intervention, but collected outcome data through a baseline maternal/newborn birth registry.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

CM

Eligibility Criteria

Inclusion Criteria

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

2. Consent provided

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

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

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Goldenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Drexel University College of Medicine

Locations

University of Buenos Aires

Buenos Aires, , Argentina

IMSALUD / San Carlos University

Guatemala City, , Guatemala

Jawaharlal Nehru Medical College

Belagavi, , India

Indira Gandhi Government Medical College

Nagpur, , India

Moi University School of Medicine

Eldoret, , Kenya

The Aga Khan University

Karachi, , Pakistan

University Teaching Hospital

Lusaka, , Zambia

Countries

Argentina; Guatemala; India; Kenya; Pakistan; Zambia

References

Pasha O, McClure EM, Wright LL, Saleem S, Goudar SS, Chomba E, Patel A, Esamai F, Garces A, Althabe F, Kodkany B, Mabeya H, Manasyan A, Carlo WA, Derman RJ, Hibberd PL, Liechty EK, Krebs N, Hambidge KM, Buekens P, Moore J, Jobe AH, Koso-Thomas M, Wallace DD, Stalls S, Goldenberg RL; EMONC Trial Investigators. A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial. BMC Med. 2013 Oct 3;11:215. doi: 10.1186/1741-7015-11-215.

Reference Type: DERIVED

PMID: 24090370 (View on PubMed)

Pasha O, Goldenberg RL, McClure EM, Saleem S, Goudar SS, Althabe F, Patel A, Esamai F, Garces A, Chomba E, Mazariegos M, Kodkany B, Belizan JM, Derman RJ, Hibberd PL, Carlo WA, Liechty EA, Hambidge KM, Buekens P, Wallace D, Howard-Grabman L, Stalls S, Koso-Thomas M, Jobe AH, Wright LL. Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the Global Network's EmONC trial). BMC Pregnancy Childbirth. 2010 Dec 14;10:82. doi: 10.1186/1471-2393-10-82.

Reference Type: DERIVED

PMID: 21156060 (View on PubMed)

Related Links

http://gn.rti.org/

The Global Network for Women's and Children's Health Research website contains information regarding the EmONC Trial, as well as other Global Network studies.

Other Identifiers

GN EmONC

Identifier Type: -

Identifier Source: org_study_id