An mHealth Trial to Promote the Use of Postpartum Contraception

NCT ID: NCT03612518

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 970 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2019-08-01

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.

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.

Conditions

Contraception Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Text and Voice Messages

Participants will receive text messages and voice messages

Group Type: EXPERIMENTAL

Text and Voice Messages

Intervention Type: BEHAVIORAL

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.

Interactive Phone Call

Participants will receive interactive phone calls

Group Type: EXPERIMENTAL

Interactive Phone Call

Intervention Type: BEHAVIORAL

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Junaid-ur-Rehman Siddiqui

OTHER

Sponsor Role: lead

Responsible Party

Junaid-ur-Rehman Siddiqui

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xaher Gul, DrPH(c)

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes Society

Waqas Hameed, MSc

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes Society

Junaid-ur-Rehman Siddiqui, BBA

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes Society

Sharmeen Hussain, MPH

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes Society

Ishaque Sheikh, MSc

Role: PRINCIPAL_INVESTIGATOR

Marie Stopes Society

Locations

Suraj Social Franchise

Hafizabad, Punjab Province, Pakistan

Suraj Social Franchise

Jhang, Punjab Province, Pakistan

Suraj Social Franchise

Kasur, Punjab Province, Pakistan

Suraj Social Franchise

Toba Tek Singh, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Ishaque Sheikh, MSc

Role: CONTACT

ishaque.sheikh@mariestopes.org.pk

+92-111-538-538 ext. 229

Junaid-ur-Rehman Siddiqui, BBA

Role: CONTACT

junaidrehman1994@hotmail.com

+92-111-538-538 ext. 232

Facility Contacts

Ishaque Sheikh, MSc

Role: primary

ishaque.sheikh@mariestopes.org.pk

+92-21-111-538-538 ext. 229

Ishaque Sheikh, MSc

Role: primary

ishaque.sheikh@mariestopes.org.pk

+92-21-111-538-538 ext. 229

Ishaque Sheikh, MSc

Role: primary

ishaque.sheikh@mariestopes.org.pk

+92-21-111-538-538 ext. 229

Ishaque Sheikh, MSc

Role: primary

ishaque.sheikh@mariestopes.org.pk

+92-21-111-538-538 ext. 229

References

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.

Reference Type: BACKGROUND

PMID: 26115146 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26643491 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32813276 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31395034 (View on PubMed)

Other Identifiers

009-17

Identifier Type: -

Identifier Source: org_study_id