An mHealth Trial to Promote the Use of Postpartum Contraception (PPFP)

An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan

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.

Study Overview

• Status: Unknown
• Conditions: Contraception Behavior
• Intervention / Treatment: Behavioral: Text and Voice Messages; Behavioral: Interactive Phone Call

Detailed Description

The study will be a three-arm, 10-month, multicentre, parallel-group, randomized controlled trial which will be conducted at 15 Suraj social franchise(SF) health facilities in Punjab province of Pakistan. Pregnant women aged 15-44 years who are in their first or second trimester and have a mobile phone for their own use will be eligible to participate in this study. The participants will be randomly allocated to one of three study arms: a) voice and text messages; b) interactive telephone-based counselling; or c) control arm (no additional phone-based support). The intervention counselling module will be developed based on the Integrated Behaviour Model which was recently adapted, and tested for the family planning context in Pakistan. It will broadly cover birth-preparedness, birth spacing and contraception, and postnatal care. The phone-based intervention aims to improve women's ability to use contraception by providing them with information about a range of methods, access to family planning methods through outlets such as Suraj SF providers, connecting them with MSS field health educators to help them reach the centres, motivation by re-enforcing the benefits of contraceptive use on women's quality of life, and dispelling myths and misconceptions about modern contraceptive methods. Risk differences will be used as the measure of effect of the intervention on the outcomes.

• Study Type: Interventional
• Enrollment (Anticipated): 970
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Hafizabad, Punjab, Pakistan
      • Suraj Social Franchise
    • Jhang, Punjab, Pakistan
      • Suraj Social Franchise
    • Kasur, Punjab, Pakistan
      • Suraj Social Franchise
    • Toba Tek Singh, Punjab, Pakistan
      • Suraj Social Franchise

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Married
• Pregnant women with gestational age up to 20 weeks
• 15-44 years old throughout duration of study
• Literate
• Access to a cellphone
• Living in the study's catchment area

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Text and Voice Messages; Participants will receive text messages and voice messages	Behavioral: Text and Voice Messages; 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.
Experimental: Interactive Phone Call; Participants will receive interactive phone calls	Behavioral: Interactive Phone Call; 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.
No Intervention: Control; Participants in this arm will not be exposed to any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention to Adopt Modern Contraception	The proportion of subjects enrolled in the program who state that they intend to adopt any modern family planning method to delay their next birth by 24 months (by type contraceptive method and time within 42 days of postpartum period)	Through study completion, an average of six months

Collaborators and Investigators

• Sponsor: Junaid-ur-Rehman Siddiqui
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2018
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: RCT; mhealth; postpartum family planning
• Other Study ID Numbers: 009-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Publication
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No