Clinical trial NCT01073488: Emergency Obstetric and Neonatal Care: The EmONC Trial
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
First posted: 2010-02-23
Enrollment: 267181
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Composite of either >28 week / >1000 gram stillbirth or 7 day neonatal mortality rate
timeFrame: 7 days post delivery
Secondary outcomes:
measure: Maternal mortality rate
timeFrame: 42 days post delivery
measure: Maternal morbidity rates
timeFrame: 42 days post delivery
measure: Stillbirth rate
timeFrame: Delivery
measure: 7-day neonatal mortality rate
timeFrame: 7 days post delivery
measure: 28-day neonatal mortality rate
timeFrame: 28 days post delivery
measure: Rates of mothers transported to a referral hospital.
timeFrame: 42 days post delivery
measure: Rates of neonates/infants transported to a referral hospital
timeFrame: 42 days post delivery
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: University of Buenos Aires
city: Guatemala City
country: Guatemala
facility: IMSALUD / San Carlos University
city: Belgaum
country: India
facility: Jawaharlal Nehru Medical College
city: Nagpur
country: India
facility: Indira Gandhi Government Medical College
city: Eldoret
country: Kenya
facility: Moi University School of Medicine
city: Karachi
country: Pakistan
facility: The Aga Khan University
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: Drexel University College of Medicine
name: Robert Goldenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.