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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01389219
Other study ID # 770-Ped/ERC-06
Secondary ID
Status Completed
Phase N/A
First received July 6, 2011
Last updated July 7, 2011
Start date October 2007
Est. completion date September 2010

Study information

Verified date October 2007
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority Ethical Review Committee: Aga Khan University
Study type Interventional

Clinical Trial Summary

Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum & neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan


Description:

Introduction of a community-based intervention package including prevention strategies, early recognition and management of common postpartum & neonatal problems, as well as prompt referral of high risk/complicated cases through trained first level primary health care workers, will result in a significant reduction in Postpartum maternal and neonatal mortality in Pakistan.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

- Neonates delivered within the study area

Exclusion Criteria:

- Neonates delivered outside the study area

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Intervention
A comprehensive package of intervention will be developed for the mothers and newborn infants which will be comprised of; Provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation (iron & vitamin A), cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases. Provision of Information on family planning, birth spacing, LAM counseling, hygiene, danger signs recognition and complications readiness. Nutrition counseling regarding immediate and exclusive breastfeeding and optimum postpartum diets. 5. Danger signs of newborn illnesses and maternal complications associated with labor and the postpartum period, care seeking. Early referral for subsequent maternal and newborn morbidities, such as anemia, postpartum depression, fistulas, prolapsed uterus and infections.

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Aga Khan University John Snow, Inc., Pakistan Ministry of Health, Population Council, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visit by LHWs The aim is to increase the visits of LHWs and examine the newborn within 48- 72 hours of birth Within 48 - 72 hours of birth No
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