NCT05045599

Brief Summary

Aim To evaluate the impact of an integrated Family Planning-Maternal,Newborn and Child Health service delivery model to increase coverage of MCM in a rural Pakistan. Objectives

  • To gain an understanding of the cultural and health service delivery contexts to inform a socio-culturally appropriate and acceptable intervention package scalable in rural Pakistan.
  • To implement the intervention package at health facilities and outreach communities through existing public and private sector resources
  • To measure the impact and level of effectiveness of interventions on the uptake MCM
  • To identify and quantify the drivers of improved uptake of voluntary methods of FP especially MCM

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
125,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

September 7, 2021

Last Update Submit

September 7, 2021

Conditions

Reproductive Behavior, Family Planning Services

Keywords

RMNCH, FP

Outcome Measures

Primary Outcomes (1)

  • mCPR

    Number of women age 15-49 years currently married who are using (or whose partner is using) a modern contraceptive method. (Modern methods include: male and female sterilization, injectable, intrauterine devices (IUDs), contraceptive pills, implants, male condoms, the standard days method, locational amenorrhea method, and emergency contraception)

    18 -24 Months

Secondary Outcomes (5)

  • Unmet need

    18- 24 months

  • Demand satisfied

    18- 24 months

  • Women attitude towards family planning

    18- 24 months

  • Unwanted pregnancy/births

    18- 24 months

  • Inter-pregnancy Interval

    18- 24 months

Study Arms (2)

Integration of Family planning in Maternal, Newborn and Child Health

EXPERIMENTAL

Strengthening of capacity of LHWs and Health care provider in providing integrated services Ensure Sustained supplies are available Community Mobilization Infrastructure support to ensure privacy and confidentiality Improvement of data recording, reporting and use

Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health

Standard of care

ACTIVE COMPARATOR
Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health

Interventions

Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child HealthBEHAVIORAL

Community engagement to improve awareness, and use of family planning products and services

Also known as: Community Mobilization
Integration of Family planning in Maternal, Newborn and Child HealthStandard of care

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy women of reproductive age living in the study areas

You may not qualify if:

  • non resident living foe short term less than three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (1)

  • Memon ZA, Reale S, Ahmed W, Spencer R, Lashari TH, Bhutta Z, Soltani H. Effects of Integrating Family Planning With Maternal, Newborn, and Child Health Services on Uptake of Voluntary Modern Contraceptive Methods in Rural Pakistan: Protocol for a Quasi-experimental Study. JMIR Res Protoc. 2022 Mar 8;11(3):e35291. doi: 10.2196/35291.

    PMID: 35258461DERIVED

MeSH Terms

Conditions

Reproductive Behavior

Interventions

Child Health

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Central Study Contacts

Zahid A Memon, MPH

CONTACT

+9213085550859zahid.memon@aku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished University Professor

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 16, 2021

Study Start

October 1, 2020

Primary Completion

December 30, 2022

Study Completion

December 31, 2023

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)