Emergency Obstetric and Neonatal Care: The EmONC Trial

Maternal Morbidity and Mortality Clinical Trial

— EmONC  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073488
• Other study ID #: GN EmONC
• Status: Completed
• Phase: N/A
• First received: February 21, 2010
• Last updated: November 15, 2013
• Start date: December 2008
• Est. completion date: October 2011

Study information

• Verified date: November 2013
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267181
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Maternal Morbidity and Mortality
• Stillbirth and Neonatal Mortality

Intervention

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.

Locations

Country	Name	City	State
Argentina	University of Buenos Aires	Buenos Aires
Guatemala	IMSALUD / San Carlos University	Guatemala City
India	Jawaharlal Nehru Medical College	Belgaum
India	Indira Gandhi Government Medical College	Nagpur
Kenya	Moi University School of Medicine	Eldoret
Pakistan	The Aga Khan University	Karachi
Zambia	University Teaching Hospital	Lusaka

Sponsors (1)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health

Countries where clinical trial is conducted

Argentina,  Guatemala,  India,  Kenya,  Pakistan,  Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate		7 days post delivery	No
Secondary	Maternal mortality rate		42 days post delivery	No
Secondary	Maternal morbidity rates		42 days post delivery	No
Secondary	Stillbirth rate		Delivery	No
Secondary	7-day neonatal mortality rate		7 days post delivery	No
Secondary	28-day neonatal mortality rate		28 days post delivery	No
Secondary	Rates of mothers transported to a referral hospital.		42 days post delivery	No
Secondary	Rates of neonates/infants transported to a referral hospital		42 days post delivery	No

External Links

•   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.