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Completed

NCT Number: NCT02579785

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

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.

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Key information

Conditions

Contraception Abortion Post-abortion

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marie Stopes Bangladesh Maternity Clinic,, Chittagong, Bangladesh

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth Intervention

Behavioral

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.

Primary outcomes

  1. Use of long acting and reversible contraceptive at 4 months

    Time frame: 4 months

    Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant)

Secondary outcomes

  1. Use of long acting and reversible contraceptive at 2 weeks and 12 months

    Time frame: 2 weeks and 12 months

    Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant)

  2. Use of any modern method at 2 weeks, 4 months and 12 months

    Time frame: 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)

  3. Pregnancy

    Time frame: 4 months and 12 months

    Proportion of subjects pregnant that self-report pregnancy at the time of follow-up

  4. Menstrual Regulation

    Time frame: 4 months and 12 months

    Proportion of subjects that self report having had an MR procedure since baseline

Sponsors and collaborators

Lead sponsor

Marie Stopes International

Other

Collaborators

  • Ipas
  • London School of Hygiene and Tropical Medicine

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 20, 2015
Registry last updated
Feb 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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