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Contraception BehaviorPPFPNCT03612518

An mHealth Trial to Promote the Use of Postpartum Contraception

A study testing Text and Voice Messages and Interactive Phone Call in people with Contraception Behavior, run by Junaid-ur-Rehman Siddiqui at 4 sites in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Read more about this study

Who is it for?
Ages 15 to 44 years, women only
Conditions the study is for
Contraception Behavior
What is being tested?
Text and Voice Messages and Interactive Phone Call
Could I receive a placebo?
No, everyone receives an active treatment
How many people
970 participants
Where
4 sitesPakistan
Study dates
15 Sep 2018to 1 Aug 2019
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 15 to 44 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Married
  • Pregnant women with gestational age up to 20 weeks
  • 15-44 years old throughout duration of study
  • Literate
  • Access to a cellphone
  • Living in the study's catchment area

Who cannot join

  • Not up to 20 weeks pregnant
  • Not between 15-44 years old for the study duration
  • Illiterate
  • Does not have regular access to a cellphone
  • Not residing within the catchment area
  • Does not provide consent to participate

Trial locations and contacts

4 sites in 1 country.

Ishaque Sheikh, MSc contact

+92-111-538-538 ext. 229

ishaque.sheikh@mariestopes.org.pk

Junaid-ur-Rehman Siddiqui, BBA contact

+92-111-538-538 ext. 232

junaidrehman1994@hotmail.com

Pakistan4 sites

  • Suraj Social Franchise

    Hafizabad, Punjab Province

    Ishaque Sheikh, MSc, +92-21-111-538-538 ext. 229, ishaque.sheikh@mariestopes.org.pk

  • Suraj Social Franchise

    Jhang, Punjab Province

    Ishaque Sheikh, MSc, +92-21-111-538-538 ext. 229, ishaque.sheikh@mariestopes.org.pk

  • Suraj Social Franchise

    Kasur, Punjab Province

    Ishaque Sheikh, MSc, +92-21-111-538-538 ext. 229, ishaque.sheikh@mariestopes.org.pk

  • Suraj Social Franchise

    Toba Tek Singh, Punjab Province

    Ishaque Sheikh, MSc, +92-21-111-538-538 ext. 229, ishaque.sheikh@mariestopes.org.pk

Other trials in Pakistan

About this study

Official title: An mHealth, Multi-Centre Randomized Controlled Trial to Promote Use of Postpartum Contraception Amongst Rural Women in Punjab, Pakistan

Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.

Read the detailed description

The study will be a three-arm, 10-month, multicentre, parallel-group, randomized controlled trial which will be conducted at 15 Suraj social franchise(SF) health facilities in Punjab province of Pakistan. Pregnant women aged 15-44 years who are in their first or second trimester and have a mobile phone for their own use will be eligible to participate in this study. The participants will be randomly allocated to one of three study arms: a) voice and text messages; b) interactive telephone-based counselling; or c) control arm (no additional phone-based support). The intervention counselling module will be developed based on the Integrated Behaviour Model which was recently adapted, and tested for the family planning context in Pakistan. It will broadly cover birth-preparedness, birth spacing and contraception, and postnatal care. The phone-based intervention aims to improve women's ability to use contraception by providing them with information about a range of methods, access to family planning methods through outlets such as Suraj SF providers, connecting them with MSS field health educators to help them reach the centres, motivation by re-enforcing the benefits of contraceptive use on women's quality of life, and dispelling myths and misconceptions about modern contraceptive methods. Risk differences will be used as the measure of effect of the intervention on the outcomes.

Being tested
Text and Voice Messages, Interactive Phone Call
Keywords
postpartum family planning, RCT, mhealth
Medical subject headings
Contraception Behavior

What participants receive

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

  • Text and Voice MessagesBehavioural

    Participants in this study arm will periodically receive information regarding antenatal- and postnatal care and family planning services through text and voice messages from the fifth gestational month until the post-partum period of 42 days.

  • Interactive Phone CallBehavioural

    Participants in this study arm will receive information regarding antenatal- and postnatal care and family planning services through periodic interactive phone calls from the fifth gestational month until the post-partum period.

Study groups in NCT03612518
Study groupRoleWhat they receive
Text and Voice MessagesExperimentalParticipants will receive text messages and voice messages
Receives: Behavioral: Text and Voice Messages
Interactive Phone CallExperimentalParticipants will receive interactive phone calls
Receives: Behavioral: Interactive Phone Call
ControlNo interventionParticipants in this arm will not be exposed to any intervention.

What is being measured

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

  1. Postpartum Contraceptive Uptake

    Proportion of subjects enrolled in each of the three groups who adopt any modern family planning method to delay next pregnancy

    Measured: Through study completion, an average of six months

  2. Skilled Birth

    Proportion of women who gave birth in a health facility or through a skilled birth professional

    Measured: Through study completion, an average of six months

  3. Immunisation

    Proportion of women reported to immunise the newborn at birth

    Measured: Through study completion, an average of six months

Secondary outcomes (1)

  1. Intention to Adopt Modern Contraception

    The proportion of subjects enrolled in the program who state that they intend to adopt any modern family planning method to delay their next birth by 24 months (by type contraceptive method and time within 42 days of postpartum period)

    Measured: Through study completion, an average of six months

Timeline

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

  1. First posted2 Aug 2018
  2. Study start15 Sep 2018 (estimated)
  3. Primary completion1 Aug 2019 (estimated)
  4. Study completion1 Aug 2019 (estimated)

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
None (open label)
Enrolment
970 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03612518
Sponsor's protocol ID
009-17
Acronym
PPFP
Status last verified
Aug 2018
First submitted
27 Jul 2018
Last updated
2 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD will only be shared for underlying results in a publication. Furthermore, de-identified participant data pertinent only to the research paper will be shared.

Publications

  • Smith C, Gold J, Ngo TD, Sumpter C, Free C. Mobile phone-based interventions for improving contraception use. Cochrane Database Syst Rev. 2015 Jun 26;2015(6):CD011159. doi: 10.1002/14651858.CD011159.pub2.

    PubMed 26115146

  • Cleland J, Shah IH, Daniele M. Interventions to Improve Postpartum Family Planning in Low- and Middle-Income Countries: Program Implications and Research Priorities. Stud Fam Plann. 2015 Dec;46(4):423-41. doi: 10.1111/j.1728-4465.2015.00041.x.

    PubMed 26643491

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

    PubMed 32813276

  • Gul X, Hameed W, Hussain S, Sheikh I, Siddiqui JU. A study protocol for an mHealth, multi-centre randomized control trial to promote use of postpartum contraception amongst rural women in Punjab, Pakistan. BMC Pregnancy Childbirth. 2019 Aug 8;19(1):283. doi: 10.1186/s12884-019-2427-z.

    PubMed 31395034

Questions about this trial

What is this clinical trial studying?

A study testing Text and Voice Messages and Interactive Phone Call in people with Contraception Behavior, run by Junaid-ur-Rehman Siddiqui at 4 sites in Pakistan.

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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Pakistan. 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?

Results are not available in the source record.

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

Contact Ishaque Sheikh, MSc (+92-111-538-538 ext. 229, ishaque.sheikh@mariestopes.org.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postpartum Contraceptive Uptake (time frame: Through study completion, an average of six months). The study lists 3 primary outcomes in all. 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 NCT03612518, which also lists 4 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 2 Aug 2018.

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