NCT03612518

Brief Summary

Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.

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
970

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

July 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

July 27, 2018

Last Update Submit

August 1, 2018

Conditions

Keywords

postpartum family planningRCTmhealth

Outcome Measures

Primary Outcomes (3)

  • Postpartum Contraceptive Uptake

    Proportion of subjects enrolled in each of the three groups who adopt any modern family planning method to delay next pregnancy

    Through study completion, an average of six months

  • Skilled Birth

    Proportion of women who gave birth in a health facility or through a skilled birth professional

    Through study completion, an average of six months

  • Immunisation

    Proportion of women reported to immunise the newborn at birth

    Through study completion, an average of six months

Secondary Outcomes (1)

  • Intention to Adopt Modern Contraception

    Through study completion, an average of six months

Study Arms (3)

Text and Voice Messages

EXPERIMENTAL

Participants will receive text messages and voice messages

Behavioral: Text and Voice Messages

Interactive Phone Call

EXPERIMENTAL

Participants will receive interactive phone calls

Behavioral: Interactive Phone Call

Control

NO INTERVENTION

Participants in this arm will not be exposed to any intervention.

Interventions

Participants in this study arm will periodically receive information regarding antenatal- and postnatal care and family planning services through text and voice messages from the fifth gestational month until the post-partum period of 42 days.

Text and Voice Messages

Participants in this study arm will receive information regarding antenatal- and postnatal care and family planning services through periodic interactive phone calls from the fifth gestational month until the post-partum period.

Interactive Phone Call

Eligibility Criteria

Age15 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Married
  • Pregnant women with gestational age up to 20 weeks
  • years old throughout duration of study
  • Literate
  • Access to a cellphone
  • Living in the study's catchment area

You may not qualify if:

  • Not up to 20 weeks pregnant
  • Not between 15-44 years old for the study duration
  • Illiterate
  • Does not have regular access to a cellphone
  • Not residing within the catchment area
  • Does not provide consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Suraj Social Franchise

Hafizabad, Punjab Province, Pakistan

Location

Suraj Social Franchise

Jhang, Punjab Province, Pakistan

Location

Suraj Social Franchise

Kasur, Punjab Province, Pakistan

Location

Suraj Social Franchise

Toba Tek Singh, Punjab Province, Pakistan

Location

Related Publications (4)

  • Smith C, Gold J, Ngo TD, Sumpter C, Free C. Mobile phone-based interventions for improving contraception use. Cochrane Database Syst Rev. 2015 Jun 26;2015(6):CD011159. doi: 10.1002/14651858.CD011159.pub2.

    PMID: 26115146BACKGROUND
  • Cleland J, Shah IH, Daniele M. Interventions to Improve Postpartum Family Planning in Low- and Middle-Income Countries: Program Implications and Research Priorities. Stud Fam Plann. 2015 Dec;46(4):423-41. doi: 10.1111/j.1728-4465.2015.00041.x.

    PMID: 26643491BACKGROUND
  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

  • Gul X, Hameed W, Hussain S, Sheikh I, Siddiqui JU. A study protocol for an mHealth, multi-centre randomized control trial to promote use of postpartum contraception amongst rural women in Punjab, Pakistan. BMC Pregnancy Childbirth. 2019 Aug 8;19(1):283. doi: 10.1186/s12884-019-2427-z.

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Xaher Gul, DrPH(c)

    Marie Stopes Society

    PRINCIPAL INVESTIGATOR
  • Waqas Hameed, MSc

    Marie Stopes Society

    PRINCIPAL INVESTIGATOR
  • Junaid-ur-Rehman Siddiqui, BBA

    Marie Stopes Society

    PRINCIPAL INVESTIGATOR
  • Sharmeen Hussain, MPH

    Marie Stopes Society

    PRINCIPAL INVESTIGATOR
  • Ishaque Sheikh, MSc

    Marie Stopes Society

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junaid-ur-Rehman Siddiqui, BBA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 27, 2018

First Posted

August 2, 2018

Study Start

September 15, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 2, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

IPD will only be shared for underlying results in a publication. Furthermore, de-identified participant data pertinent only to the research paper will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Publication
Access Criteria
At the time of publication, data will be submitted to a data repository and the URL will be shared with the journal, and the journal will make the information public. Requests to access data will be individually reviewed by the research team.

Locations