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

Contraception Clinical Trial

Official title:

Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in the Sylhet, Chittagong and Dhaka Regions of Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02579785
• Other study ID #: MSI-007-14
• Status: Completed
• Phase: N/A
• Start date: December 19, 2015
• Est. completion date: July 15, 2016

Study information

• Verified date: February 2021
• Source: Marie Stopes International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 972
• Est. completion date: July 15, 2016
• Est. primary completion date: July 15, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion
• Contraception
• Post-abortion

Intervention

Behavioral:
• Mhealth intervention
A series of ten automated interactive voice messages will be delivered to the participant's mobile phone over a period of 4 months. Messages will be targeted to the method of contraception the participant is using (no-method, condoms, pills, injectable, implant, copper coil). Messages will support uptake of contraception among no-method users. Messages will support existing users to continue their method and to use it correctly and will also encourage participants who are not happy with their method to switch to a different method. All messages will end with five options: Press 1 to repeat the message, press 2 to listen to recorded information about methods of contraception, press 3 to speak to a counsellor, press 4 to tell me you're fine, press 5 to stop receiving these messages.

Locations

Country	Name	City	State
Bangladesh	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	RHSTEP Clinic Khagrachhari	Chittagong
Bangladesh	RHSTEP Cox's Bazar Sadar Hospital	Chittagong
Bangladesh	RHSTEP Rangamati Sadar Hospital	Chittagong
Bangladesh	Faridpur Maternal and Child Welfare Centre	Dhaka
Bangladesh	Kishoreganj Maternal and Child Welfare Centre	Dhaka
Bangladesh	Manikganj Maternal and Child Welfare Centre	Dhaka
Bangladesh	Mari Stopes Clinic Manikgonj	Dhaka
Bangladesh	Marie Stopes Bashail Maternity Clinic	Dhaka
Bangladesh	Marie Stopes Clinic Balurmath	Dhaka
Bangladesh	Marie Stopes Clinic Gazipur	Dhaka
Bangladesh	Marie Stopes Clinic Kallyanpur	Dhaka
Bangladesh	Marie Stopes Clinic Kamrangirchar	Dhaka
Bangladesh	Marie Stopes Clinic Madaripur	Dhaka
Bangladesh	Marie Stopes Clinic Mymensingh	Dhaka
Bangladesh	Marie Stopes Clinic Sherpur	Dhaka
Bangladesh	Marie Stopes Clinic Tongi	Dhaka
Bangladesh	Marie Stopes Kadamtali Maternity Clinic	Dhaka
Bangladesh	Marie Stopes Premium 1 Clinic	Dhaka
Bangladesh	Marie Stopes Premium 2 Clinic	Dhaka
Bangladesh	Marie Stopes Referal Clinic, Tangail	Dhaka
Bangladesh	Mohammapur Fertility Services and Training Centre	Dhaka
Bangladesh	RHSTEP Dhaka Medical College Hospital	Dhaka
Bangladesh	RHSTEP Faridpur Medical College Hospital	Dhaka
Bangladesh	RHSTEP Mymensingh Medical College Hospital	Dhaka
Bangladesh	RHSTEP Sir Salaimullh Medical College Hospital	Dhaka
Bangladesh	Rupganj UHC Health Unit	Dhaka
Bangladesh	Marie Stopes Clinic Chatak	Sylhet
Bangladesh	Marie Stopes Clinic Moulvi Bazar	Sylhet
Bangladesh	Marie Stopes Sylhet Maternity Clinic	Sylhet
Bangladesh	RHSTEP Sylhet OAG Osmani Medical College Hospital	Sylhet
Bangladesh	Shreemongol UHC Health Unit	Sylhet

Sponsors (3)

Lead Sponsor	Collaborator
Marie Stopes International	Ipas, London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of long acting and reversible contraceptive at 4 months	Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant)	4 months
Secondary	Use of long acting and reversible contraceptive at 2 weeks and 12 months	Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant)	2 weeks and 12 months
Secondary	Use of any modern method at 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)	2 weeks, 4 months and 12 months
Secondary	Pregnancy	Proportion of subjects pregnant that self-report pregnancy at the time of follow-up	4 months and 12 months
Secondary	Menstrual Regulation	Proportion of subjects that self report having had an MR procedure since baseline	4 months and 12 months