An mHealth Trial to Promote the Use of Postpartum Contraception

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception Behavior

Intervention / Treatment
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* Behavioral: Text and Voice Messages
* Behavioral: Interactive Phone Call


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum family planning, RCT, mhealth