Clinical trial NCT06521138: The Effect of Transtheoretical Model-Based Motivational Interviewing on Postpartum Contraception
Official title: The Effect of Transtheoretical Model-Based Antenatal and Postnatal Motivational Interviewing on Contraceptive Self-Efficacy, Contraceptive Attitude and Contraceptive Use: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Supportive Care
Keywords: contraception
family planning
contraceptive self efficacy
contraceptive attitude
postpartum contraception
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-07-25
Enrollment: 72
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum contraceptive method use questionnaire
timeFrame: 12 weeks postpartum
measure: Contraceptive Attitude Questionnaire
timeFrame: At baseline and 12 weeks postpartum
measure: Contraceptive Self Efficacy Scale
timeFrame: At baseline and 12 weeks postpartum
Secondary outcomes:
measure: Stages of Behavior Change
timeFrame: At baseline and 12 weeks postpartum
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
affiliation: Gazi University
name: Aliye Dogan Gangal
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.