Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02579785
Recruitment Status : Completed
First Posted : October 20, 2015
Last Update Posted : February 25, 2021
Sponsor:
Collaborators:
Ipas
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Marie Stopes International

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Contraception Post-abortion Abortion Behavioral: Mhealth intervention Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 972 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in the Sylhet, Chittagong and Dhaka Regions of Bangladesh
Actual Study Start Date : December 19, 2015
Actual Primary Completion Date : July 15, 2016
Actual Study Completion Date : July 15, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: mhealth intervention
Receives standard care which includes face to face post-MR family counselling and provision of existing hotline phone number. Also receives Mobile phone based intervention for post-abortion contraceptive uptake.
 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.
No Intervention: Standard Care
Receives standard care which includes face to face post-MR family counselling and provision of existing hotline phone number.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579785


Locations
Show Show 41 study locations
Sponsors and Collaborators
Marie Stopes International
Ipas
London School of Hygiene and Tropical Medicine
Investigators
Layout table for investigator information
Principal Investigator: Kathryn Anderson, PhD Ipas
Principal Investigator: Sadid Nuremowla, PhD Marie Stopes International
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Marie Stopes International
ClinicalTrials.gov Identifier: NCT02579785    
Other Study ID Numbers: MSI-007-14
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Keywords provided by Marie Stopes International:
Family Planning
Abortion
mHealth
Behaviour Change Communication
 Menstrual Regulation
Postabortion
Bangladesh