Perinatal Problems Clinical Trial
Official title:
Community-based Perinatal and Newborn Care in Gilgit District, Northern Areas, Pakistan: an AKU-AKHSP Collaboration
Verified date | April 2015 |
Source | Aga Khan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Pakistan: Research Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3200 |
Est. completion date | September 2007 |
Est. primary completion date | February 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
Inclusion Criteria: - Pregnant women & participants who agree to participate in the study Exclusion Criteria: - Pregnant women & participants who disagree to participate in the study |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan University | Karachi | Sindh |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University | Aga Khan Health Services |
Pakistan,
Bhutta ZA. Perinatal care in Pakistan. Proceedings of the Symposium on Priorities in Perinatal Care in South Asia. September 1998, Karachi, Pakistan.
Costello AM. Perinatal health in developing countries. Trans R Soc Trop Med Hyg. 1993 Jan-Feb;87(1):1-2. — View Citation
De Muylder X. Perinatal mortality audit in a Zimbabwean district. Paediatr Perinat Epidemiol. 1989 Jul;3(3):284-93. — View Citation
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. — View Citation
Raghuveer G. Perinatal deaths: relevance of Wigglesworth's classification. Paediatr Perinat Epidemiol. 1992 Jan;6(1):45-50. — View Citation
Reducing Perinatal and Neonatal Mortality. Child Health Research Project Special Report. 1999;3:1-48.
Wigglesworth JS. Monitoring perinatal mortality. A pathophysiological approach. Lancet. 1980 Sep 27;2(8196):684-6. — View Citation
World Health Organization. Child health and development: health of the newborn. Geneva: World health Organization 1991.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in perinatal and neonatal mortality | Baseline & Endline Surveys | 3 years | No |
Secondary | Improvements in antenatal care practices | Baseline & Endline Surveys | 3 Years | No |
Secondary | Improvements in cord application practices | Baseline & Endline Surveys | 3 Years | No |
Secondary | Improvements in delaying first bath after birth | Baseline & Endline Surveys | 3 Years | No |
Secondary | Improvements in colostrum administration | Baseline & Endline Surveys | 3 Years | No |
Secondary | Improvements in initiation of breastfeeding practices within 1 hour after birth | Baseline & Endline Surveys | 3 Years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01851187 -
Effect of Perinatal Emotional Management on Maternal Emotion and Delivery Outcomes
|
N/A | |
Completed |
NCT04685252 -
Investigating a Probiotic on Mothers' Mood and Stress
|
N/A | |
Not yet recruiting |
NCT06129461 -
A Single Session Self-guided Acceptance-based Digital Intervention Targeting Food Cravings in Pregnancy
|
N/A | |
Active, not recruiting |
NCT05343403 -
Parental Participation on the Neonatal Ward - the neoPARTNER Study
|
||
Active, not recruiting |
NCT04184544 -
Scaling up Evidence Based MNCH Interventions : A Quasi Experimental Study Umeed e Nau (UeN) Project
|
N/A | |
Terminated |
NCT04264520 -
Initial Intervention Efficacy for an Online PTSD Intervention for Pregnant Women
|
N/A | |
Completed |
NCT05429242 -
The Relation Between Placental Volume at the 1st Trimester and Perinatal Prognosis
|
||
Completed |
NCT06164080 -
The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes
|
N/A | |
Recruiting |
NCT04876144 -
Kogito: App to Reduce Perinatal Psychosocial Stress
|
N/A | |
Completed |
NCT04279899 -
The Investigation of the Neonates With or With Risk of COVID-19
|
||
Completed |
NCT05225376 -
Physical Activity and Sedentary Lifestyle During Pregnancy: Feasibility and Impact Study on Sedentary Behavior
|
N/A | |
Completed |
NCT03232294 -
Fetal Front-abdominal Wall Thickness and Perinatal Outcome
|
N/A |