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ContraceptionNCT02579785

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

A study testing Mhealth intervention in people with Contraception and Post-abortion, run by Marie Stopes International at 41 sites in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Contraception, Post-abortion, Abortion
What is being tested?
Mhealth intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
972 participants
Where
41 sitesBangladesh
Study dates
19 Dec 2015to 15 Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

Bangladesh41 sites

  • Marie Stopes Bangladesh Maternity Clinic,

    Chittagong

  • Marie Stopes Clinic Brahman Baria

    Chittagong

  • Marie Stopes Clinic Chandpur, Comilla

    Chittagong

  • Marie Stopes Clinic Chittagong 1

    Chittagong

  • Marie Stopes Clinic Comilla

    Chittagong

  • Marie Stopes Clinic Cox's Bazar

    Chittagong

  • Marie Stopes Clinic Shitakunda

    Chittagong

  • Marie Stopes Femi Maternity Clinic

    Chittagong

  • RHSTEP Bandarban Clinic

    Chittagong

  • RHSTEP Chittagong Medical College Hospital

    Chittagong

  • RHSTEP Clinic Khagrachhari

    Chittagong

  • RHSTEP Cox's Bazar Sadar Hospital

    Chittagong

  • RHSTEP Rangamati Sadar Hospital

    Chittagong

  • Faridpur Maternal and Child Welfare Centre

    Dhaka

  • Kishoreganj Maternal and Child Welfare Centre

    Dhaka

  • Manikganj Maternal and Child Welfare Centre

    Dhaka

  • Mari Stopes Clinic Manikgonj

    Dhaka

  • Marie Stopes Bashail Maternity Clinic

    Dhaka

  • Marie Stopes Clinic Balurmath

    Dhaka

  • Marie Stopes Clinic Gazipur

    Dhaka

  • Marie Stopes Clinic Kallyanpur

    Dhaka

  • Marie Stopes Clinic Kamrangirchar

    Dhaka

  • Marie Stopes Clinic Madaripur

    Dhaka

  • Marie Stopes Clinic Mymensingh

    Dhaka

  • Marie Stopes Clinic Sherpur

    Dhaka

  • Marie Stopes Clinic Tongi

    Dhaka

  • Marie Stopes Kadamtali Maternity Clinic

    Dhaka

  • Marie Stopes Premium 1 Clinic

    Dhaka

  • Marie Stopes Premium 2 Clinic

    Dhaka

  • Marie Stopes Referal Clinic, Tangail

    Dhaka

  • Mohammapur Fertility Services and Training Centre

    Dhaka

  • RHSTEP Dhaka Medical College Hospital

    Dhaka

  • RHSTEP Faridpur Medical College Hospital

    Dhaka

  • RHSTEP Mymensingh Medical College Hospital

    Dhaka

  • RHSTEP Sir Salaimullh Medical College Hospital

    Dhaka

  • Rupganj UHC Health Unit

    Dhaka

  • Marie Stopes Clinic Chatak

    Sylhet

  • Marie Stopes Clinic Moulvi Bazar

    Sylhet

  • Marie Stopes Sylhet Maternity Clinic

    Sylhet

  • RHSTEP Sylhet OAG Osmani Medical College Hospital

    Sylhet

  • Shreemongol UHC Health Unit

    Sylhet

Other trials in Bangladesh

About this study

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

Read the 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.

Being tested
Mhealth intervention
Keywords
Family Planning, Abortion, mHealth, Behaviour Change Communication, Menstrual Regulation, Postabortion, Bangladesh

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mhealth interventionBehavioural

    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.

Study groups in NCT02579785
Study groupRoleWhat they receive
mhealth interventionExperimentalReceives 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.
Receives: Behavioral: Mhealth intervention
Standard CareNo interventionReceives standard care which includes face to face post-MR family counselling and provision of existing hotline phone number.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 4 months

Secondary outcomes (4)

  1. 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)

    Measured: 2 weeks and 12 months

  2. 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)

    Measured: 2 weeks, 4 months and 12 months

  3. Pregnancy

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

    Measured: 4 months and 12 months

  4. Menstrual Regulation

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

    Measured: 4 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2015 (estimated)
  2. Study start19 Dec 2015
  3. Primary completion15 Jul 2016
  4. Study completion15 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
972 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02579785
Sponsor's protocol ID
MSI-007-14
Status last verified
Feb 2021
First submitted
16 Oct 2015
Last updated
25 Feb 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32779730

  • 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.

    PubMed 31558596

  • 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.

    PubMed 28974209

Questions about this trial

What is this clinical trial studying?

A study testing Mhealth intervention in people with Contraception and Post-abortion, run by Marie Stopes International at 41 sites in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Use of long acting and reversible contraceptive at 4 months (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02579785, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.

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