Clinical trial NCT02579785: Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in Bangladesh
Official title: Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in the Sylhet, Chittagong and Dhaka Regions of Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Post-abortion
Abortion
Keywords: Family Planning
Abortion
mHealth
Behaviour Change Communication
Menstrual Regulation
Postabortion
Bangladesh
Lead sponsor: Marie Stopes International
Sponsor class: OTHER
Collaborators: name: Ipas
name: London School of Hygiene and Tropical Medicine
First posted: 2015-10-20
Enrollment: 972
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of long acting and reversible contraceptive at 4 months
timeFrame: 4 months
Secondary outcomes:
measure: Use of long acting and reversible contraceptive at 2 weeks and 12 months
timeFrame: 2 weeks and 12 months
measure: Use of any modern method at 2 weeks, 4 months and 12 months
timeFrame: 2 weeks, 4 months and 12 months
measure: Pregnancy
timeFrame: 4 months and 12 months
measure: Menstrual Regulation
timeFrame: 4 months and 12 months
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Marie Stopes Bangladesh Maternity Clinic,
city: Chittagong
country: Bangladesh
facility: Marie Stopes Clinic Brahman Baria
city: Chittagong
country: Bangladesh
facility: Marie Stopes Clinic Chandpur, Comilla
city: Chittagong
country: Bangladesh
facility: Marie Stopes Clinic Chittagong 1
city: Chittagong
country: Bangladesh
facility: Marie Stopes Clinic Comilla
city: Chittagong
country: Bangladesh
facility: Marie Stopes Clinic Cox's Bazar
city: Chittagong
country: Bangladesh
facility: Marie Stopes Clinic Shitakunda
city: Chittagong
country: Bangladesh
facility: Marie Stopes Femi Maternity Clinic
city: Chittagong
country: Bangladesh
facility: RHSTEP Bandarban Clinic
city: Chittagong
country: Bangladesh
facility: RHSTEP Chittagong Medical College Hospital
city: Chittagong
country: Bangladesh
facility: RHSTEP Clinic Khagrachhari
city: Chittagong
country: Bangladesh
facility: RHSTEP Cox's Bazar Sadar Hospital
city: Chittagong
country: Bangladesh
facility: RHSTEP Rangamati Sadar Hospital
city: Dhaka
country: Bangladesh
facility: Faridpur Maternal and Child Welfare Centre
city: Dhaka
country: Bangladesh
facility: Kishoreganj Maternal and Child Welfare Centre
city: Dhaka
country: Bangladesh
facility: Manikganj Maternal and Child Welfare Centre
city: Dhaka
country: Bangladesh
facility: Mari Stopes Clinic Manikgonj
city: Dhaka
country: Bangladesh
facility: Marie Stopes Bashail Maternity Clinic
city: Dhaka
country: Bangladesh
facility: Marie Stopes Clinic Balurmath
city: Dhaka
country: Bangladesh
facility: Marie Stopes Clinic Gazipur
city: Dhaka
country: Bangladesh
facility: Marie Stopes Clinic Kallyanpur
city: Dhaka
country: Bangladesh
facility: Marie Stopes Clinic Kamrangirchar
city: Dhaka
country: Bangladesh
facility: Marie Stopes Clinic Madaripur
city: Dhaka
country: Bangladesh
facility: Marie Stopes Clinic Mymensingh
city: Dhaka
country: Bangladesh
facility: Marie Stopes Clinic Sherpur
city: Dhaka
country: Bangladesh
facility: Marie Stopes Clinic Tongi
city: Dhaka
country: Bangladesh
facility: Marie Stopes Kadamtali Maternity Clinic
city: Dhaka
country: Bangladesh
facility: Marie Stopes Premium 1 Clinic
city: Dhaka
country: Bangladesh
facility: Marie Stopes Premium 2 Clinic
city: Dhaka
country: Bangladesh
facility: Marie Stopes Referal Clinic, Tangail
city: Dhaka
country: Bangladesh
facility: Mohammapur Fertility Services and Training Centre
city: Dhaka
country: Bangladesh
facility: RHSTEP Dhaka Medical College Hospital
city: Dhaka
country: Bangladesh
facility: RHSTEP Faridpur Medical College Hospital
city: Dhaka
country: Bangladesh
facility: RHSTEP Mymensingh Medical College Hospital
city: Dhaka
country: Bangladesh
facility: RHSTEP Sir Salaimullh Medical College Hospital
city: Dhaka
country: Bangladesh
facility: Rupganj UHC Health Unit
city: Sylhet
country: Bangladesh
facility: Marie Stopes Clinic Chatak
city: Sylhet
country: Bangladesh
facility: Marie Stopes Clinic Moulvi Bazar
city: Sylhet
country: Bangladesh
facility: Marie Stopes Sylhet Maternity Clinic
city: Sylhet
country: Bangladesh
facility: RHSTEP Sylhet OAG Osmani Medical College Hospital
city: Sylhet
country: Bangladesh
facility: Shreemongol UHC Health Unit
Study officials:
affiliation: Ipas
name: Kathryn Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marie Stopes International
name: Sadid Nuremowla, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
citation: Reiss K, Andersen K, Pearson E, Biswas K, Taleb F, Ngo TD, Hossain A, Barnard S, Smith C, Carpenter J, Menzel J, Footman K, Keenan K, Douthwaite M, Reena Y, Mahmood HR, Tabbassum T, Colombini M, Bacchus L, Church K. Unintended Consequences of mHealth Interactive Voice Messages Promoting Contraceptive Use After Menstrual Regulation in Bangladesh: Intimate Partner Violence Results From a Randomized Controlled Trial. Glob Health Sci Pract. 2019 Sep 26;7(3):386-403. doi: 10.9745/GHSP-D-19-00015. Print 2019 Sep.
citation: Reiss K, Andersen K, Barnard S, Ngo TD, Biswas K, Smith C, Carpenter J, Church K, Nuremowla S, Pearson E. Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial. BMC Public Health. 2017 Oct 3;17(1):769. doi: 10.1186/s12889-017-4703-z.