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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Standard of care
Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
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
Behavioral: Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aga Khan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United Nations
Global Affairs Canada

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Conditions

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