An mHealth Trial to Promote the Use of Postpartum Contraception

Contraception Behavior Clinical Trial

— PPFP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03612518
• Other study ID #: 009-17
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: August 2018
• Source: Marie Stopes Society
• Contact: Ishaque Sheikh, MSc
• Phone: +92-111-538-538
• Email: ishaque.sheikh[@]mariestopes.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 970
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Suraj Social Franchise	Hafizabad	Punjab
Pakistan	Suraj Social Franchise	Jhang	Punjab
Pakistan	Suraj Social Franchise	Kasur	Punjab
Pakistan	Suraj Social Franchise	Toba Tek Singh	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Junaid-ur-Rehman Siddiqui

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

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. Review. — View Citation

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;(6):CD011159. doi: 10.1002/14651858.CD011159.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Immunisation	Proportion of women reported to immunise the newborn at birth	Through study completion, an average of six months
Secondary	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