Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in Bangladesh

Not Applicable

Completed

• Conditions: Abortion; Contraception; Post-abortion

• Registration Number: NCT02579785
• Lead Sponsor: Marie Stopes International

Brief Summary

The purpose of this study is to assess whether a mobile phone intervention can be effectively used to improve post menstrual regulation contraceptive uptake and continuation in Bangladesh.

The study will consist of two phases: Phase I: A formative phase to understand barriers to post-abortion contraceptive uptake and continuation and the content and modality of messages most appropriate for women in the study areas; and Phase II: An RCT will be conducted to test the effectiveness of the mHealth intervention developed during the formative phase on contraceptive use.

Detailed Description

The proposed study aims to develop and evaluate a mHealth intervention to promote post-abortion contraceptive uptake and continuation among menstrual regulation clients in the Sylhet, Chittagong and Dhaka regions of Bangladesh.

The aim of the formative phase of the study is to develop an interactive two-way messaging service for post-MR clients. The messaging service will deliver information relating to the women's contraceptive method of choice as well as information about other modern contraceptive methods. This part of the study will focus on determining the modality, content, timing, language and acceptability of messaging services for post menstrual regulation clients.

The aim of the RCT phase is to measure the effect of mHealth on uptake or switching to long-acting reversible contraceptives at the 4 month and 12 month follow ups. The investigators expect mHealth to have a positive effect on uptake and a negative effect on discontinuation rates of contraceptive users.

Study Timeline

• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2015-10-19
• Study First Posted: 2015-10-20
• Study Start: 2015-12-19
• Primary Completion: 2016-07-15
• Study Completion: 2016-07-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 972

Inclusion Criteria

• Received menstrual regulation services using Manual Vacuum Aspiration (MVA) or Medical Abortion (MA)
• Have a personal mobile telephone
• Agree to receive messages on mobile about family planning
• Provide informed consent for participation

Exclusion Criteria

• Received anaesthesia for their MVA procedure
• Intend to become pregnant within the next six months
• Intend to use, or for partner to use, a permanent method of contraception (i.e. sterilisation) within the next six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Use of long acting and reversible contraceptive at 4 months	4 months	Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant)

Secondary Outcome Measures

Name	Time	Method
Use of long acting and reversible contraceptive at 2 weeks and 12 months	2 weeks and 12 months	Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant)
Use of any modern method at 2 weeks, 4 months and 12 months	2 weeks, 4 months and 12 months	The proportion of subjects that self report using any effective modern contraceptive method: Modern contraceptive methods are defined according to the WHO as those associated with \<10% 12 month pregnancy rates (WHO, 2011)
Pregnancy	4 months and 12 months	Proportion of subjects pregnant that self-report pregnancy at the time of follow-up
Menstrual Regulation	4 months and 12 months	Proportion of subjects that self report having had an MR procedure since baseline

Trial Locations

Locations (41)

Marie Stopes Bangladesh Maternity Clinic,; 🇧🇩 Chittagong, Bangladesh

Marie Stopes Clinic Brahman Baria; 🇧🇩 Chittagong, Bangladesh

Marie Stopes Clinic Chandpur, Comilla; 🇧🇩 Chittagong, Bangladesh

Marie Stopes Clinic Chittagong 1; 🇧🇩 Chittagong, Bangladesh

Marie Stopes Clinic Comilla; 🇧🇩 Chittagong, Bangladesh

Marie Stopes Clinic Cox's Bazar; 🇧🇩 Chittagong, Bangladesh

Marie Stopes Clinic Shitakunda; 🇧🇩 Chittagong, Bangladesh

Marie Stopes Femi Maternity Clinic; 🇧🇩 Chittagong, Bangladesh

RHSTEP Bandarban Clinic; 🇧🇩 Chittagong, Bangladesh

RHSTEP Chittagong Medical College Hospital; 🇧🇩 Chittagong, Bangladesh

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