PPFP: An mHealth Trial to Promote the Use of Postpartum Contraception

Sponsor
Junaid-ur-Rehman Siddiqui (Other)
Overall Status
Unknown status
CT.gov ID
NCT03612518
Collaborator
(none)
970
4
3
10.5
242.5
23.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Text and Voice Messages
  • Behavioral: Interactive Phone Call
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
970 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Anticipated Study Start Date :
Sep 15, 2018
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Aug 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Postpartum Contraceptive Uptake [Through study completion, an average of six months]

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

  2. Skilled Birth [Through study completion, an average of six months]

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

  3. Immunisation [Through study completion, an average of six months]

    Proportion of women reported to immunise the newborn at birth

Secondary Outcome Measures

  1. Intention to Adopt Modern Contraception [Through study completion, an average of six months]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 44 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Suraj Social Franchise Hafizabad Punjab Pakistan
2 Suraj Social Franchise Jhang Punjab Pakistan
3 Suraj Social Franchise Kasur Punjab Pakistan
4 Suraj Social Franchise Toba Tek Singh Punjab Pakistan

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Junaid-ur-Rehman Siddiqui, Principal Investigator, Marie Stopes Society
ClinicalTrials.gov Identifier:
NCT03612518
Other Study ID Numbers:
  • 009-17
First Posted:
Aug 2, 2018
Last Update Posted:
Aug 2, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Junaid-ur-Rehman Siddiqui, Principal Investigator, Marie Stopes Society

Study Results

No Results Posted as of Aug 2, 2018