Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration

NCT02412293 | Completed

• 1 other identifier: AKU-AKHSP
• Study Type: interventional
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief Summary

There is limited evidence from community-based interventions to guide the development of effective maternal, perinatal and newborn care practices and services in developing countries. Investigators planned to evaluate the impact of a low-cost package of community-based interventions implemented through government sector lady health workers (LHWs) and community health workers (CHWs) of a NGO namely Aga Khan Health Services on perinatal and neonatal outcomes in a sub-population of the remote mountainous district of Gilgit, Northern Pakistan. A community-based package for use by LHWs and CHWs geared towards prevention and promotion of maternal and newborn health practices and services will be developed based on formative research in the study district. The package will include promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level. The health workers will be trained in recognition of danger sign that warrant referral to health care service. LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period. In addition to this, community mobilization activities included formation of CHCs and creation of support for the uptake of the interventions. Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area. The intervention areas will receive the intervention package in addition to the routine standard health services. Outcome measures will include changes in maternal and newborn-care practices and perinatal and neonatal mortality rates between the intervention and control areas.

Conditions

Perinatal Problems; Still Births; Neonatal Deaths

Keywords

Perinatal; neonatal; newborn; mortality

Outcome Measures

Primary Outcomes (1)

• Reduction in perinatal and neonatal mortality

  Baseline \& Endline Surveys

  3 years

Secondary Outcomes (5)

• Improvements in antenatal care practices

  3 Years

• Improvements in cord application practices

  3 Years

• Improvements in delaying first bath after birth

  3 Years

• Improvements in colostrum administration

  3 Years

• Improvements in initiation of breastfeeding practices within 1 hour after birth

  3 Years

Study Arms (2)

Intervention

EXPERIMENTAL

Health Education \& Promotion: LHWs and CHWs will delivered the package via community awareness sessions and two one-to-one counselling sessions to pregnant women during third trimester and five newborn assessment visits in the neonatal period in intervention areas. Training of Health Workers: The LHWs and CHWs will receive trainings on IMNCI-based training package. Community Mobilization: For community mobilization and education, two types of tools will be used one group session by use of flip charts and group session by use of video.

Behavioral: Health Education & Promotion; Other: Training of Health Workers; Behavioral: Community Mobilization

Control

NO INTERVENTION

Control areas will continue to receive the routine standard health services of governmental and non-governmental organizations in the area.

Interventions

Health Education & Promotion BEHAVIORAL

Promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level.

Intervention

Training of Health Workers OTHER

Training of health workers on recognition of danger sign that warrant referral to health care service.

Intervention

Community Mobilization BEHAVIORAL

Community mobilization activities included formation of community health committees and creation of support for the uptake of the interventions.

Intervention

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women \& participants who agree to participate in the study

You may not qualify if:

• Pregnant women \& participants who disagree to participate in the study

Sponsors & Collaborators

• Aga Khan University: lead
• Aga Khan Health Services: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (9)

• Reducing Perinatal and Neonatal Mortality. Child Health Research Project Special Report. 1999;3:1-48.

  RESULT

• Costello AM. Perinatal health in developing countries. Trans R Soc Trop Med Hyg. 1993 Jan-Feb;87(1):1-2. doi: 10.1016/0035-9203(93)90395-7.

  PMID: 8465375 RESULT

• World Health Organization. Child health and development: health of the newborn. Geneva: World health Organization 1991.

  RESULT

• De Muylder X. Perinatal mortality audit in a Zimbabwean district. Paediatr Perinat Epidemiol. 1989 Jul;3(3):284-93. doi: 10.1111/j.1365-3016.1989.tb00380.x.

  PMID: 2788880 RESULT

• Fauveau V, Wojtyniak B, Mostafa G, Sarder AM, Chakraborty J. Perinatal mortality in Matlab, Bangladesh: a community-based study. Int J Epidemiol. 1990 Sep;19(3):606-12. doi: 10.1093/ije/19.3.606.

  PMID: 2262255 RESULT

• Wigglesworth JS. Monitoring perinatal mortality. A pathophysiological approach. Lancet. 1980 Sep 27;2(8196):684-6. doi: 10.1016/s0140-6736(80)92717-8. No abstract available.

  PMID: 6106794 RESULT

• Raghuveer G. Perinatal deaths: relevance of Wigglesworth's classification. Paediatr Perinat Epidemiol. 1992 Jan;6(1):45-50. doi: 10.1111/j.1365-3016.1992.tb00743.x.

  PMID: 1553317 RESULT

• Bhutta ZA. Perinatal care in Pakistan. Proceedings of the Symposium on Priorities in Perinatal Care in South Asia. September 1998, Karachi, Pakistan.

  RESULT

• Memon ZA, Khan GN, Soofi SB, Baig IY, Bhutta ZA. Impact of a community-based perinatal and newborn preventive care package on perinatal and neonatal mortality in a remote mountainous district in Northern Pakistan. BMC Pregnancy Childbirth. 2015 Apr 30;15:106. doi: 10.1186/s12884-015-0538-8.

  PMID: 25925407 DERIVED

MeSH Terms

Conditions

Perinatal Death

Condition Hierarchy (Ancestors)

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

Study Officials

• Zulfiqar A Bhutta, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 9, 2015
• Study Start: July 1, 2001
• Primary Completion: February 1, 2006
• Study Completion: September 1, 2007
• Last Updated: April 9, 2015

Record last verified: 2015-04

Locations

PA (1)