NCT06521138

Brief Summary

The goal of this clinical trial is to evaluate the effect of transtheoretical model-based antenatal and postnatal motivational interviewing on contraceptive self-efficacy, contraceptive attitude, and postpartum contraception use. This study was planned as a single-centre, parallel-group, randomized controlled trial design. The study group consisted of 72 women at 28-32 weeks of gestation (intervention group n=36, control group n=36). Block randomization stratified by parity will be used to assign participants to groups. The intervention group will receive antenatal and postnatal motivational interviewing in addition to routine care, while the control group will receive routine care only. Outcomes will be evaluated at 12 weeks postpartum. Data will be collected using a personal information form, Contraceptive Self-Efficacy Scale, Contraceptive Attitude Questionnaire, Contraceptive Use Form and Stages of Behavior Change Short Form.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 2, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

July 16, 2024

Last Update Submit

February 24, 2026

Conditions

Keywords

contraceptionfamily planningcontraceptive self efficacycontraceptive attitudepostpartum contraception

Outcome Measures

Primary Outcomes (3)

  • Postpartum contraceptive method use questionnaire

    The questionnaire assesses the contraceptive method used by the participants in the postpartum period. It consist of questions assessing the contraceptive method used by the participants and the time of onset. The number of participants using modern contraceptive methods in the postpartum period has been reported.

    12 weeks postpartum

  • Contraceptive Attitude Questionnaire

    It was developed to assess contraceptive attitude. Contraceptive attitude questionnaire consists of three sub-dimensions ; effects on family economy and sexual life, effects on moral values of the society, effects on men and religion. The higher the score, the higher the contraceptive attitude.

    At baseline and 12 weeks postpartum

  • Contraceptive Self Efficacy Scale

    Women's contraceptive self-efficacy will be assessed using the Turkish version of the Contraceptive Self-Efficacy Scale. The scale consists of 11 items and three sub-dimensions; (1) husband/partner communication, (2) provider communication, (3) choosing and managing a method. The total score ranged from 0 to 110. Higher scores indicate higher levels of contraceptive self-efficacy.

    At baseline and 12 weeks postpartum

Secondary Outcomes (3)

  • Stages of Behavior Change

    At baseline and 12 weeks postpartum

  • Consistent use of contraceptive methods

    12 weeks postpartum

  • Contraceptive method satisfaction

    12 weeks postpartum

Study Arms (2)

Motivational interviewing group

EXPERIMENTAL

Antenatal and postnatal motivational interviewing based on the transtheoretical model will be applied.

Behavioral: Motivational interviewing group

Control group

OTHER

The control group receiving routine care.

Other: Control group

Interventions

The intervention group will receive motivational interviewing based on the transtheoretical model in addition to routine care. Motivational interviews are structured in line with the stages of change and behavioral change processes, which are the basic structures of the transtheoretical model. Three sessions of motivational interviewing with a session duration of 30 min will be implemented. Two sessions of motivational interviewing in the prenatal period and one session of motivational interviewing in the postnatal period.

Also known as: Transtheoretical model-based motivational interviewing group
Motivational interviewing group

Participants in the control group will receive routine care at the center.

Control group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe sample of this study consists of pregnant women.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • to 32 weeks of gestation
  • At least literate in Turkish
  • Agree to participate in the study
  • Willing to participate in the postpartum follow-up
  • Having access to a smartphone

You may not qualify if:

  • Women who do not have a sexual partner
  • Women who give consent for female sterilization immediately after delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, 06490, Turkey (Türkiye)

Location

Related Publications (17)

  • Bergo CJ, Handler A, Geller S, Grobman WA, Awadalla S, Rankin K. Interpregnancy Interval and Severe Maternal Morbidity in Iowa, 2009 to 2014. Womens Health Issues. 2021 Sep-Oct;31(5):503-509. doi: 10.1016/j.whi.2021.04.005. Epub 2021 Jun 1.

    PMID: 34088600BACKGROUND
  • Ball SJ, Pereira G, Jacoby P, de Klerk N, Stanley FJ. Re-evaluation of link between interpregnancy interval and adverse birth outcomes: retrospective cohort study matching two intervals per mother. BMJ. 2014 Jul 23;349:g4333. doi: 10.1136/bmj.g4333.

    PMID: 25056260BACKGROUND
  • Hutcheon JA, Nelson HD, Stidd R, Moskosky S, Ahrens KA. Short interpregnancy intervals and adverse maternal outcomes in high-resource settings: An updated systematic review. Paediatr Perinat Epidemiol. 2019 Jan;33(1):O48-O59. doi: 10.1111/ppe.12518. Epub 2018 Oct 12.

    PMID: 30311955BACKGROUND
  • ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.

    PMID: 29683911BACKGROUND
  • American College of Obstetricians and Gynecologists; Society for Maternal-Fetal Medicine. Obstetric Care Consensus No. 8: Interpregnancy Care. Obstet Gynecol. 2019 Jan;133(1):e51-e72. doi: 10.1097/AOG.0000000000003025.

    PMID: 30575677BACKGROUND
  • Dev R, Kohler P, Feder M, Unger JA, Woods NF, Drake AL. A systematic review and meta-analysis of postpartum contraceptive use among women in low- and middle-income countries. Reprod Health. 2019 Oct 29;16(1):154. doi: 10.1186/s12978-019-0824-4.

    PMID: 31665032BACKGROUND
  • Brunson MR, Klein DA, Olsen CH, Weir LF, Roberts TA. Postpartum contraception: initiation and effectiveness in a large universal healthcare system. Am J Obstet Gynecol. 2017 Jul;217(1):55.e1-55.e9. doi: 10.1016/j.ajog.2017.02.036. Epub 2017 Feb 28.

    PMID: 28257962BACKGROUND
  • Wakuma B, Mosisa G, Etafa W, Mulisa D, Tolossa T, Fetensa G, Besho M, Gebre M, Tsegaye R. Postpartum modern contraception utilization and its determinants in Ethiopia: A systematic review and meta-analysis. PLoS One. 2020 Dec 14;15(12):e0243776. doi: 10.1371/journal.pone.0243776. eCollection 2020.

    PMID: 33315904BACKGROUND
  • Lopez LM, Grey TW, Tolley EE, Chen M. Brief educational strategies for improving contraception use in young people. Cochrane Database Syst Rev. 2016 Mar 30;3(3):CD012025. doi: 10.1002/14651858.CD012025.pub2.

    PMID: 27027480BACKGROUND
  • Zapata LB, Murtaza S, Whiteman MK, Jamieson DJ, Robbins CL, Marchbanks PA, D'Angelo DV, Curtis KM. Contraceptive counseling and postpartum contraceptive use. Am J Obstet Gynecol. 2015 Feb;212(2):171.e1-8. doi: 10.1016/j.ajog.2014.07.059. Epub 2014 Aug 2.

    PMID: 25093946BACKGROUND
  • Cavallaro FL, Benova L, Owolabi OO, Ali M. A systematic review of the effectiveness of counselling strategies for modern contraceptive methods: what works and what doesn't? BMJ Sex Reprod Health. 2020 Oct;46(4):254-269. doi: 10.1136/bmjsrh-2019-200377. Epub 2019 Dec 11.

    PMID: 31826883BACKGROUND
  • Engelbert Bain L, Amu H, Enowbeyang Tarkang E. Barriers and motivators of contraceptive use among young people in Sub-Saharan Africa: A systematic review of qualitative studies. PLoS One. 2021 Jun 4;16(6):e0252745. doi: 10.1371/journal.pone.0252745. eCollection 2021.

    PMID: 34086806BACKGROUND
  • Wilson A, Nirantharakumar K, Truchanowicz EG, Surenthirakumaran R, MacArthur C, Coomarasamy A. Motivational interviews to improve contraceptive use in populations at high risk of unintended pregnancy: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2015 Aug;191:72-9. doi: 10.1016/j.ejogrb.2015.05.010. Epub 2015 Jun 11.

    PMID: 26093351BACKGROUND
  • Rodriguez J, Abutouk M, Roque K, Sridhar A. Personalized contraceptive counseling: helping women make the right choice. Open Access J Contracept. 2016 May 11;7:89-96. doi: 10.2147/OAJC.S81546. eCollection 2016.

    PMID: 29386940BACKGROUND
  • Gregory EF, Maddox AI, Levine LD, Fiks AG, Lorch SA, Resnicow K. Motivational interviewing to promote interconception health: A scoping review of evidence from clinical trials. Patient Educ Couns. 2022 Nov;105(11):3204-3212. doi: 10.1016/j.pec.2022.07.009. Epub 2022 Jul 16.

    PMID: 35870992BACKGROUND
  • Frost H, Campbell P, Maxwell M, O'Carroll RE, Dombrowski SU, Williams B, Cheyne H, Coles E, Pollock A. Effectiveness of Motivational Interviewing on adult behaviour change in health and social care settings: A systematic review of reviews. PLoS One. 2018 Oct 18;13(10):e0204890. doi: 10.1371/journal.pone.0204890. eCollection 2018.

    PMID: 30335780BACKGROUND
  • Whiting-Collins L, Grenier L, Winch PJ, Tsui A, Donohue PK. Measuring contraceptive self-efficacy in sub-Saharan Africa: development and validation of the CSESSA scale in Kenya and Nigeria. Contracept X. 2020 Oct 9;2:100041. doi: 10.1016/j.conx.2020.100041. eCollection 2020.

    PMID: 33145490BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Aliye Dogan Gangal

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blinding of the outcome assessors in this study was planned. The data obtained from the research will be coded as A and B by an independent researcher and transferred to the SPSS program. The data will be analyzed by an independent statistical expert.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 25, 2024

Study Start

May 2, 2024

Primary Completion

December 10, 2024

Study Completion

December 10, 2024

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

There are no plans to make individual participant data available to other researchers.

Locations