The Effect of Transtheoretical Model-Based Motivational Interviewing on Postpartum Contraception

NCT ID: NCT06521138

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Supportive Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Motivational interviewing group

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

Group Type EXPERIMENTAL

Motivational interviewing group

Intervention Type BEHAVIORAL

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.

Control group

The control group receiving routine care.

Group Type OTHER

Control group

Intervention Type OTHER

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

Interventions

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Motivational interviewing group

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.

Intervention Type BEHAVIORAL

Control group

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

Intervention Type OTHER

Other Intervention Names

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Transtheoretical model-based motivational interviewing group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Gazi University

OTHER

Sponsor Role lead

Responsible Party

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Aliye DOĞAN GANGAL

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aliye Dogan Gangal

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

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Gazi University

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Aliye Dogan Gangal, MSc

Role: CONTACT

905389662381

Facility Contacts

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Aliye Dogan Gangal

Role: primary

05389662381

References

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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.

Reference Type BACKGROUND
PMID: 34088600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25056260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30311955 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 29683911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30575677 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31665032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28257962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33315904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27027480 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25093946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31826883 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34086806 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26093351 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29386940 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35870992 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30335780 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33145490 (View on PubMed)

Other Identifiers

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711519

Identifier Type: -

Identifier Source: org_study_id

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