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

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ClinicalTrials.gov Identifier: NCT02579785
Recruitment Status : Unknown
Verified May 2016 by Marie Stopes International.
Recruitment status was:  Active, not recruiting
First Posted : October 20, 2015
Last Update Posted : May 11, 2016
Sponsor:
Collaborators:
Ipas
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
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.


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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 969 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
Study Start Date : December 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

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.



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



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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

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
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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, Bangladesh
Sponsors and Collaborators
Marie Stopes International
Ipas
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Kathryn Anderson, PhD Ipas
Principal Investigator: Sadid Nuremowla, PhD Marie Stopes International

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marie Stopes International
ClinicalTrials.gov Identifier: NCT02579785     History of Changes
Other Study ID Numbers: MSI-007-14
First Posted: October 20, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Keywords provided by Marie Stopes International:
Family Planning
Abortion
mHealth
Behaviour Change Communication
Menstrual Regulation
Postabortion
Bangladesh
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs