Effectiveness of Integrating Family Planning - Maternal, Newborn and Child Health (MNCH) Services on Uptake of Voluntary Modern Contraceptive Methods (RMNCH FP)

September 7, 2021 updated by: Dr Zulfiqar Ahmed Bhutta, Aga Khan University

Effectiveness of Integrating Family Planning - Maternal, Newborn and Child Health (MNCH) Services on Uptake of Voluntary Modern Contraceptive Methods in Rural District of Sindh Province: A Quasi-experimental Study

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

Study Overview

Detailed Description

Interventions focusing on community outreach programs and interpersonal communications increase social acceptance of FP methods. However, home based counseling alone is not sufficient for the uptake and continuation of FP methods and developing linkages with health facilities and maintaining privacy at a health facility and being more culturally and religiously acceptable is also important. With this in mind, efforts have been made involving facility and community level health care providers for provision of MNCH services as the primary mandate of National Maternal Newborn and Child Health program. However, there are still deficiencies at inter and intra facility level, for example; a lack of coordination among departments such as Paediatrics and Gynecology & Obstetrics, lack of management level coordination with front line providers, lack of equipment and logistics management manifested as imbalance demand and supply and lack of overall governing bodies . Thus, overarching interventions covering service delivery platforms at facility and community levels necessitates the integration and scaling up of FP and MNCH services.

The theoretical underpinning of behavior change will be based on the Theoretical Domain Framework (TDF) v2.0. The TDF will be applied to provide an in-depth exploration and understanding of factors on the demand and supply side and their interaction with and influences on FP uptake. This project aims to implement a complex intervention (see figure 2) within health facilities and their catchment communities. This complex intervention includes a series of strategies involving community engagement by extensive community mobilization, availability of trained staff and sustainable supply of commodities with the required recording and reporting system. Continuous process monitoring and quality assurance will help to replicate the success and address possible barriers during implementation of the intervention. The mechanism of action built on the TDF adopts domains and constructs including, knowledge, skills, beliefs and intentions. Furthermore, the TDF provides a detailed understanding of complex behaviour thus will be used to evaluate the impact of complex interventions/ strategies.

Research Question What is the impact of integrating FP- MNCH services on uptake of voluntary modern contraceptive methods in a rural district of Sindh province, Pakistan?

Study Type

Interventional

Enrollment (Anticipated)

125000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Recruiting
        • Aga Khan University
        • Contact:
        • Principal Investigator:
          • Zahid Memon, MPH
        • Principal Investigator:
          • Hora Soltani, PhD
        • Sub-Investigator:
          • Rachel Spencer, PhD
        • Sub-Investigator:
          • Sophie Reale, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women of reproductive age living in the study areas

Exclusion Criteria:

  • non resident living foe short term less than three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care
Community engagement to improve awareness, and use of family planning products and services
Other Names:
  • Community Mobilization
Experimental: Integration of Family planning in Maternal, Newborn and Child Health
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
Community engagement to improve awareness, and use of family planning products and services
Other Names:
  • Community Mobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mCPR
Time Frame: 18 -24 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unmet need
Time Frame: 18- 24 months

Proportion of women who

  1. are not pregnant and not postpartum amenorrhea and are considered fecund and want to postpone their next birth for 2 or more years or stop childbearing altogether but are not using a contraceptive method, or
  2. have a mistimed or unwanted current pregnancy, or
  3. are postpartum amenorrhea and their last birth in the last 2 years was mistimed or unwanted.
18- 24 months
Demand satisfied
Time Frame: 18- 24 months

Proportion of demand satisfied by modern methods:

Current contraceptive use (any modern method) divided by Unmet need + current contraceptive use (any method)

18- 24 months
Women attitude towards family planning
Time Frame: 18- 24 months
Proportion of women showing positive attitude towards FP
18- 24 months
Unwanted pregnancy/births
Time Frame: 18- 24 months

Planning status of births/pregnancies Women reported whether their births/pregnancies were wanted at the time (planned birth), at a later time (mistimed birth), or not at all (unwanted birth).

Sample: Current pregnancies and births in the 5 years before the survey to women age 15-49

18- 24 months
Inter-pregnancy Interval
Time Frame: 18- 24 months
The number of months between a live birth and the conception of the next live birth. This was calculated by subtracting the "Date of last live birth" item from the date of birth to obtain a live-birth interval, then subtracting gestational age (months) of the birth from the live-birth interval.
18- 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 7, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021-3606-18261-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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