NCT01389219

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
Last Updated

July 8, 2011

Status Verified

October 1, 2007

Enrollment Period

2.9 years

First QC Date

July 6, 2011

Last Update Submit

July 7, 2011

Conditions

Keywords

Post partumNeonatecommunity health care workers

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control

NO INTERVENTION

Control arm

Intervention clusters

OTHER

Focus is to increase the number of visits by LHWs to the newborn baby and to ensure that this visit occurs within 48-72 hours of birth. The purpose of this visit was the provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation, cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases.

Other: Intervention

Interventions

A comprehensive package of intervention will be developed for the mothers and newborn infants which will be comprised of; 1. 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. 2. Provision of Information on family planning, birth spacing, LAM counseling, hygiene, danger signs recognition and complications readiness. 3. 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.

Intervention clusters

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Neonates delivered within the study area

You may not qualify if:

  • Neonates delivered outside the study area

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Sukkur, Sindh, Pakistan

Location

MeSH Terms

Conditions

Maternal Death

Interventions

Methods

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Zulfiqar A Bhutta, MBBS, PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 8, 2011

Study Start

October 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

July 8, 2011

Record last verified: 2007-10

Locations