Emergency Obstetric and Neonatal Care: The EmONC Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT01073488
First received: February 21, 2010
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Maternal Morbidity and Mortality
Stillbirth and Neonatal Mortality
Behavioral: Community Mobilization, HBLSS and facility improvement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluation of an Emergency Obstetric and Neonatal Care (EmONC) Intervention Package to Reduce Adverse Pregnancy Outcomes in Low Resource Settings (The EmONC Trial)

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate [ Time Frame: 7 days post delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal mortality rate [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]
  • Maternal morbidity rates [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]
  • Stillbirth rate [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • 7-day neonatal mortality rate [ Time Frame: 7 days post delivery ] [ Designated as safety issue: No ]
  • 28-day neonatal mortality rate [ Time Frame: 28 days post delivery ] [ Designated as safety issue: No ]
  • Rates of mothers transported to a referral hospital. [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]
  • Rates of neonates/infants transported to a referral hospital [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]

Enrollment: 267181
Study Start Date: December 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Name: CM
No Intervention: Control
The control group did not receive an intervention, but collected outcome data through a baseline maternal/newborn birth registry.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073488

Locations
Argentina
University of Buenos Aires
Buenos Aires, Argentina
Guatemala
IMSALUD / San Carlos University
Guatemala City, Guatemala
India
Jawaharlal Nehru Medical College
Belgaum, India
Indira Gandhi Government Medical College
Nagpur, India
Kenya
Moi University School of Medicine
Eldoret, Kenya
Pakistan
The Aga Khan University
Karachi, Pakistan
Zambia
University Teaching Hospital
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Investigators
Principal Investigator: Robert Goldenberg, MD Drexel University College of Medicine
  More Information

Additional Information:
No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT01073488     History of Changes
Other Study ID Numbers: GN EmONC
Study First Received: February 21, 2010
Last Updated: November 15, 2013
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Pregnancy
Maternal child health
Developing countries
Stillbirth
Neonatal mortality
Maternal mortality
Community intervention
Community mobilization
Home-based Life Saving Skills

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014