Supportive CareNCT06521138
The Effect of Transtheoretical Model-Based Motivational Interviewing on Postpartum Contraception
A study testing Motivational interviewing group in people with Supportive Care, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Supportive Care
- What is being tested?
- Motivational interviewing group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2024to 10 Dec 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who do not have a sexual partner
- Women who give consent for female sterilization immediately after delivery
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Supportive Care
- Being tested
- Motivational interviewing group, Control group
- Keywords
- contraception, family planning, contraceptive self efficacy, contraceptive attitude, postpartum contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewing groupBehavioural
Also called Transtheoretical model-based 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.
Control groupOther
Participants in the control group will receive routine care at the center.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing group | Experimental | Antenatal and postnatal motivational interviewing based on the transtheoretical model will be applied. Receives: Behavioral: Motivational interviewing group |
| Control group | Other | The control group receiving routine care. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At baseline and 12 weeks postpartum
Secondary outcomes (3)
Stages of Behavior Change
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.
Measured: At baseline and 12 weeks postpartum
Consistent use of contraceptive methods
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.
Measured: 12 weeks postpartum
Contraceptive method satisfaction
The satisfaction level of participants using modern contraceptive methods is evaluated.
Measured: 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start2 May 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Supportive CareStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliye DOĞAN GANGAL, Gazi University
- Investigators
- Aliye Dogan Gangal, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521138
- Sponsor's protocol ID
- 711519
- Status last verified
- Feb 2026
- First submitted
- 16 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to make individual participant data available to other researchers.
Publications
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.
PubMed 34088600Ball 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.
PubMed 25056260Hutcheon 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.
PubMed 30311955ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
PubMed 29683911American 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.
PubMed 30575677Dev 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.
PubMed 31665032Brunson 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.
PubMed 28257962Wakuma 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.
PubMed 33315904Lopez 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.
PubMed 27027480Zapata 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.
PubMed 25093946Cavallaro 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.
PubMed 31826883Engelbert 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.
PubMed 34086806Wilson 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.
PubMed 26093351Rodriguez 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.
PubMed 29386940Gregory 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.
PubMed 35870992
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06521138
- Acronym / sponsor ID
- 711519
- Conditions
- Supportive Care
- Keywords
- contraception, family planning, contraceptive self efficacy, contraceptive attitude, postpartum contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing group | Experimental | Behavioral: Motivational interviewing groupAntenatal and postnatal motivational interviewing based on the transtheoretical model will be applied. |
| Control group | Other | Other: Control groupThe control group receiving routine care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Women who do not have a sexual partner
- Women who give consent for female sterilization immediately after delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewing groupAlso: Transtheoretical model-based motivational interviewing groupThe 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. | Behavioural | Motivational interviewing group |
| Control groupParticipants in the control group will receive routine care at the center. | Other | Control group |
Primary outcome
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.
Contraceptive Attitude Questionnaire
Time frame: At baseline and 12 weeks postpartum
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.
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.
3 secondary outcomes
Stages of Behavior Change
Time frame: At baseline and 12 weeks postpartum
Consistent use of contraceptive methods
Time frame: 12 weeks postpartum
Contraceptive method satisfaction
Time frame: 12 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 34088600Bergo 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.
- Background: PubMed 25056260Ball 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.
- Background: PubMed 30311955Hutcheon 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.
- Background: PubMed 29683911ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
- Background: PubMed 30575677American 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.
- Background: PubMed 31665032Dev 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.
- Background: PubMed 28257962Brunson 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.
- Background: PubMed 33315904Wakuma 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.
- Background: PubMed 27027480Lopez 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.
- Background: PubMed 25093946Zapata 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.
- Background: PubMed 31826883Cavallaro 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.
- Background: PubMed 34086806Engelbert 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.
- Individual participant dataSharing planned: No. There are no plans to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliye Dogan Gangal principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing group in people with Supportive Care, run by Gazi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum contraceptive method use questionnaire (time frame: 12 weeks postpartum). 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 NCT06521138, which also lists 17 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 27 Feb 2026.