Improved Accessibility of EmONC Services for Maternal and Newborn Health: a Community Based Project

NCT01751945 | Completed DMC

• 1 other identifier: RAF/FIN/AKU-2/2012/00030
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether an integrated EmONC package (community mobilization, training of community-based health care providers and a maternal and neonatal health pack) reduce perinatal and neonatal mortality.

Conditions

Sepsis; Pneumonia; Omphalitis; Birth Asphyxia; Respiratory Distress Syndrome; Eclampsia; Postpartum Hemorrhage; Puerperal Sepsis

Keywords

EmONC; Neonatal mortality; Perinatal mortality

Outcome Measures

Primary Outcomes (1)

• Perinatal mortality

  12 months

Study Arms (2)

EmONC package

EXPERIMENTAL

The EmONC package consists of: 1. Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing. 2. Enhanced trainings of community-level health care providers to provide effective maternal and neonatal health services and referral of complicated cases to health facilities and creation of linkages amongst health care providers. 3. Community mobilisation

Behavioral: EmONC package

Standard of care

NO INTERVENTION

Standard care as per national policy

Interventions

EmONC package BEHAVIORAL

The EmONC package consists of: 1. Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing. 2. Enhanced trainings of community-level health care providers to provide effective maternal and neonatal health services and referral of complicated cases to health facilities and creation of linkages amongst health care providers. 3. Community mobilisation

EmONC package

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Expectant women and their newborns in the study area

You may not qualify if:

• Pregnant women not belonging to the study area

Sponsors & Collaborators

• Aga Khan University: lead
• Department for International Development, United Kingdom: collaborator

Study Sites (1)

Field Site

Rahim Yar Khan, Punjab Province, Pakistan

Location

Related Publications (2)

• Ariff S, Jiwani U, Rizvi A, Muhammad S, Hussain A, Ahmed I, Hussain M, Usman M, Iqbal J, Memon Z, Soofi SB, Bhutta ZA. Effect of Maternal and Newborn Care Service Package on Perinatal and Newborn Mortality: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2356609. doi: 10.1001/jamanetworkopen.2023.56609.

  PMID: 38372998 DERIVED

• Turab A, Ariff S, Habib MA, Ahmed I, Hussain M, Rashid A, Memon Z, Khan MI, Soofi S, Bhutta ZA. Improved accessibility of emergency obstetrics and newborn care (EmONC) services for maternal and newborn health: a community based project. BMC Pregnancy Childbirth. 2013 Jun 24;13:136. doi: 10.1186/1471-2393-13-136.

  PMID: 23800194 DERIVED

MeSH Terms

Conditions

Sepsis; Pneumonia; Asphyxia Neonatorum; Respiratory Distress Syndrome; Eclampsia; Postpartum Hemorrhage; Puerperal Infection; Perinatal Death

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiration Disorders; Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pregnancy Complications, Infectious; Death

Study Officials

• Dr. Sajid Soofi, MBBS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: December 18, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 9, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)