NCT02579785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
972

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

41 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2016

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

October 16, 2015

Last Update Submit

February 23, 2021

Conditions

Keywords

Family PlanningAbortionmHealthBehaviour Change CommunicationMenstrual RegulationPostabortionBangladesh

Outcome Measures

Primary Outcomes (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)

    4 months

Secondary Outcomes (4)

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

    2 weeks and 12 months

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

    2 weeks, 4 months and 12 months

  • Pregnancy

    4 months and 12 months

  • Menstrual Regulation

    4 months and 12 months

Study Arms (2)

mhealth intervention

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Receives standard care which includes face to face post-MR family counselling and provision of existing hotline phone number.

Interventions

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.

mhealth intervention

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Marie Stopes Bangladesh Maternity Clinic,

Chittagong, Bangladesh

Location

Marie Stopes Clinic Brahman Baria

Chittagong, Bangladesh

Location

Marie Stopes Clinic Chandpur, Comilla

Chittagong, Bangladesh

Location

Marie Stopes Clinic Chittagong 1

Chittagong, Bangladesh

Location

Marie Stopes Clinic Comilla

Chittagong, Bangladesh

Location

Marie Stopes Clinic Cox's Bazar

Chittagong, Bangladesh

Location

Marie Stopes Clinic Shitakunda

Chittagong, Bangladesh

Location

Marie Stopes Femi Maternity Clinic

Chittagong, Bangladesh

Location

RHSTEP Bandarban Clinic

Chittagong, Bangladesh

Location

RHSTEP Chittagong Medical College Hospital

Chittagong, Bangladesh

Location

RHSTEP Clinic Khagrachhari

Chittagong, Bangladesh

Location

RHSTEP Cox's Bazar Sadar Hospital

Chittagong, Bangladesh

Location

RHSTEP Rangamati Sadar Hospital

Chittagong, Bangladesh

Location

Faridpur Maternal and Child Welfare Centre

Dhaka, Bangladesh

Location

Kishoreganj Maternal and Child Welfare Centre

Dhaka, Bangladesh

Location

Manikganj Maternal and Child Welfare Centre

Dhaka, Bangladesh

Location

Mari Stopes Clinic Manikgonj

Dhaka, Bangladesh

Location

Marie Stopes Bashail Maternity Clinic

Dhaka, Bangladesh

Location

Marie Stopes Clinic Balurmath

Dhaka, Bangladesh

Location

Marie Stopes Clinic Gazipur

Dhaka, Bangladesh

Location

Marie Stopes Clinic Kallyanpur

Dhaka, Bangladesh

Location

Marie Stopes Clinic Kamrangirchar

Dhaka, Bangladesh

Location

Marie Stopes Clinic Madaripur

Dhaka, Bangladesh

Location

Marie Stopes Clinic Mymensingh

Dhaka, Bangladesh

Location

Marie Stopes Clinic Sherpur

Dhaka, Bangladesh

Location

Marie Stopes Clinic Tongi

Dhaka, Bangladesh

Location

Marie Stopes Kadamtali Maternity Clinic

Dhaka, Bangladesh

Location

Marie Stopes Premium 1 Clinic

Dhaka, Bangladesh

Location

Marie Stopes Premium 2 Clinic

Dhaka, Bangladesh

Location

Marie Stopes Referal Clinic, Tangail

Dhaka, Bangladesh

Location

Mohammapur Fertility Services and Training Centre

Dhaka, Bangladesh

Location

RHSTEP Dhaka Medical College Hospital

Dhaka, Bangladesh

Location

RHSTEP Faridpur Medical College Hospital

Dhaka, Bangladesh

Location

RHSTEP Mymensingh Medical College Hospital

Dhaka, Bangladesh

Location

RHSTEP Sir Salaimullh Medical College Hospital

Dhaka, Bangladesh

Location

Rupganj UHC Health Unit

Dhaka, Bangladesh

Location

Marie Stopes Clinic Chatak

Sylhet, Bangladesh

Location

Marie Stopes Clinic Moulvi Bazar

Sylhet, Bangladesh

Location

Marie Stopes Sylhet Maternity Clinic

Sylhet, Bangladesh

Location

RHSTEP Sylhet OAG Osmani Medical College Hospital

Sylhet, Bangladesh

Location

Shreemongol UHC Health Unit

Sylhet, Bangladesh

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • Kathryn Anderson, PhD

    Ipas

    PRINCIPAL INVESTIGATOR
  • Sadid Nuremowla, PhD

    Marie Stopes International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 20, 2015

Study Start

December 19, 2015

Primary Completion

July 15, 2016

Study Completion

July 15, 2016

Last Updated

February 25, 2021

Record last verified: 2021-02

Locations