Clinical trial NCT03612518: An mHealth Trial to Promote the Use of Postpartum Contraception
Official title: An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contraception Behavior
Keywords: postpartum family planning
RCT
mhealth
Lead sponsor: Marie Stopes Society
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 970
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Postpartum Contraceptive Uptake
timeFrame: Through study completion, an average of six months
measure: Skilled Birth
timeFrame: Through study completion, an average of six months
measure: Immunisation
timeFrame: Through study completion, an average of six months
Secondary outcomes:
measure: Intention to Adopt Modern Contraception
timeFrame: Through study completion, an average of six months
Other outcomes:
Locations:
city: Hafizabad
country: Pakistan
facility: Suraj Social Franchise
state: Punjab
city: Jhang
country: Pakistan
facility: Suraj Social Franchise
state: Punjab
city: Kasur
country: Pakistan
facility: Suraj Social Franchise
state: Punjab
city: Toba Tek Singh
country: Pakistan
facility: Suraj Social Franchise
state: Punjab
Study officials:
affiliation: Marie Stopes Society
name: Xaher Gul, DrPH(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes Society
name: Waqas Hameed, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes Society
name: Junaid-ur-Rehman Siddiqui, BBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes Society
name: Sharmeen Hussain, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes Society
name: Ishaque Sheikh, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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;2015(6):CD011159. doi: 10.1002/14651858.CD011159.pub2.
citation: 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.
citation: 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.
citation: 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.