Emergency Obstetric and Neonatal Care: The EmONC Trial (EmONC)

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

Study Overview

• Status: Completed
• Conditions: Maternal Morbidity and Mortality; Stillbirth and Neonatal Mortality
• Intervention / Treatment: Behavioral: Community Mobilization, HBLSS and facility improvement

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.

• Study Type: Interventional
• Enrollment (Actual): 267181
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: CM
No Intervention: Control; The control group did not receive an intervention, but collected outcome data through a baseline maternal/newborn birth registry.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NICHD Global Network for Women's and Children's Health
• Investigators: Principal Investigator: Robert Goldenberg, MD, Drexel University College of Medicine

Publications and helpful links

General Publications

• 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.
• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 21, 2010
• First Submitted That Met QC Criteria: February 21, 2010
• First Posted (Estimate): February 23, 2010

Study Record Updates

• Last Update Posted (Estimate): November 18, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Pregnancy; Developing countries; Neonatal mortality; Stillbirth; Maternal mortality; Community mobilization; Community intervention; Maternal child health; Home-based Life Saving Skills
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Death; Fetal Death; Emergencies; Stillbirth
• Other Study ID Numbers: GN EmONC