Emergency Obstetric and Neonatal Care: The EmONC Trial

NCT01073488 | Completed DMC

• 1 other identifier: GN EmONC
• Study Type: interventional
• Target: 267,181
• Locations: 6 countries
• Sites: 7

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.

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

Outcome Measures

Primary Outcomes (1)

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

  7 days post delivery

Secondary Outcomes (7)

• 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

Study Arms (2)

EMONC: Community mobilization, HBLSS and Facility Improvement

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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.

Also known as: CM

EMONC: Community mobilization, HBLSS and Facility Improvement

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead

Study Sites (7)

University of Buenos Aires

Buenos Aires, Argentina

Location

IMSALUD / San Carlos University

Guatemala City, Guatemala

Location

Jawaharlal Nehru Medical College

Belagavi, India

Location

Indira Gandhi Government Medical College

Nagpur, India

Location

Moi University School of Medicine

Eldoret, Kenya

Location

The Aga Khan University

Karachi, Pakistan

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (2)

• 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.

  PMID: 24090370 DERIVED

• 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.

  PMID: 21156060 DERIVED

Related 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.

MeSH Terms

Conditions

Stillbirth; Maternal Death

Condition Hierarchy (Ancestors)

Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parental Death

Study Officials

• Robert Goldenberg, MD

  Drexel University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2010
• First Posted: February 23, 2010
• Study Start: December 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 18, 2013

Record last verified: 2013-11

Locations

ZA (1); PA (1); KE (1); GU (1); AR (1); IN (2)