- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06521138
The Effect of Transtheoretical Model-Based Motivational Interviewing on Postpartum Contraception
February 24, 2026 updated by: Aliye DOĞAN GANGAL, Gazi University
The Effect of Transtheoretical Model-Based Antenatal and Postnatal Motivational Interviewing on Contraceptive Self-Efficacy, Contraceptive Attitude and Contraceptive Use: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Short gestational intervals are known to be directly associated with adverse pregnancy outcomes, such as gestational diabetes, maternal obesity, anemia, maternal mortality, severe maternal morbidity, preterm delivery, low birth weight, and infant mortality.
The most important step in establishing optimum pregnancy intervals can be achieved by meeting the contraceptive needs of postpartum women.
Motivational interviewing incorporates components of contraception counseling best practices, such as building trust, optimizing the decision-making process, improving self-efficacy, and protecting the autonomy of the individual, which allows it to be actively used in the counseling process.
Therefore, this study aimed to investigate the effects of transtheoretical model-based motivational interviewing on postpartum contraception.
In this study, the intervention group will receive two motivational counseling sessions in the antenatal period and one motivational interviewing session in the postnatal period in addition to routine care, while the control group will receive only routine care.
The data will be coded as A and B in SPSS (Statistical Package for the Social Sciences) and analyzed by an independent statistical expert.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey (Türkiye), 06490
- Gazi University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 28 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
Exclusion Criteria:
- Women who do not have a sexual partner
- Women who give consent for female sterilization immediately after delivery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Motivational interviewing group
Antenatal and postnatal motivational interviewing based on the transtheoretical model will be applied.
|
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.
Other Names:
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Other: Control group
The control group receiving routine care.
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Participants in the control group will receive routine care at the center.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum contraceptive method use questionnaire
Time Frame: 12 weeks postpartum
|
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.
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12 weeks postpartum
|
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Contraceptive Attitude Questionnaire
Time Frame: At baseline and 12 weeks postpartum
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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.
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At baseline and 12 weeks postpartum
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Contraceptive Self Efficacy Scale
Time Frame: At baseline and 12 weeks postpartum
|
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.
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At baseline and 12 weeks postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stages of Behavior Change
Time Frame: At baseline and 12 weeks postpartum
|
The transtheoretical model (stages of change model), which is widely used to determine the process of behavior change, was adapted to postpartum contraception behavior.
This form will be used to assess participants' stages of behavior change (precontemplation, contemplation, preparation, action, maintenance) regarding contraceptive use.
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At baseline and 12 weeks postpartum
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Consistent use of contraceptive methods
Time Frame: 12 weeks postpartum
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The questionnaire evaluates the consistent use of contraceptive methods by participants in the postpartum period.
It consists of questions evaluating consistent use according to the type of contraceptive method.
|
12 weeks postpartum
|
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Contraceptive method satisfaction
Time Frame: 12 weeks postpartum
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The satisfaction level of participants using modern contraceptive methods is evaluated.
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12 weeks postpartum
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aliye Dogan Gangal, Gazi University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2024
Primary Completion (Actual)
December 10, 2024
Study Completion (Actual)
December 10, 2024
Study Registration Dates
First Submitted
July 16, 2024
First Submitted That Met QC Criteria
July 22, 2024
First Posted (Actual)
July 25, 2024
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 24, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 711519
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
There are no plans to make individual participant data available to other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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