ClinicalTrials.gg
CompletedNCT07784738Updated Aug 25, 2026

Transtheoretical Model Counseling in Postpartum Contraception

An interventional study of Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive Uptake in Birth Control Behavior and Reproductive Health Attitude, sponsored by Istanbul University - Cerrahpasa. Completed at 2 sites in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Dec 2021, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study summary

The purpose of this study is to evaluate the effect of contraceptive method counseling offered to primiparous women between the ages of 18-45 in the postpartum period by motivational interviewing method based on the Transtheoretic model, on the use of contraceptive methods.

Read the detailed description

Family planning (FP) is a practice that allows individuals to protect themselves from unwanted pregnancies, to regulate the period between pregnancies, to have children whenever and however they want, and to allow individuals who cannot have children to have children. Contraceptive methods make significant contributions to the protection and improvement of women's and children's health, as well as the health of society, by preventing excessive fertility, which negatively affects the health of mothers and babies. Therefore, effective provision of FP services makes significant contributions to the health of both women, children and society.

Unmet FP services can cause unwanted pregnancies, which can be a significant medical, social and sociological problem. According to the World Health Organization, approximately 75 million unintended pregnancies occur annually, and 65% of these pregnant women either do not use any contraceptive method or use a traditional method. An average of 25 million unsafe abortions occur annually and approximately 47,000 women die for this reason.

According to the results of the Turkey Demographic and Health Survey 2018 (TDHS 2018), only 49% of women in Turkey use a modern contraceptive method, while 30% do not.

they do not use any method and 12% of women have unmet need for FP services (TNSA 2018). The use of modern methods in Turkey

The relatively low number of FP services and the high number of unmet FP services still pose a significant problem in terms of women's health. Various complications such as uteroplacental bleeding, rupture, preterm birth, low birth weight, stillbirth and maternal abortion increase in women who become pregnant again less than 12 months after birth. If couples could extend pregnancy intervals beyond 2 years, 30% of maternal deaths and 10% of child deaths would be reduced.

It is stated that it can be prevented.

The unmet need for FP in women in the postpartum period is higher than in all married women. The postpartum period requires women to cope with increased stress, financial hardship, and the challenges of caring for their infants and older children. These difficulties may cause women to neglect their own health care. Although women are willing to use a contraceptive method, they may not be able to choose the appropriate method because they are not conscious of which method to use. For this reason, contraceptive method counseling given to women in the postpartum period is of great importance.

The Transtheoretic Model is a model of intentional change and focuses on the individual's decision-making process. According to the model, in order to direct the desired behavioral change, it is necessary to take initiatives appropriate to the stages of change that the individual is in. In this study, the effect of contraceptive method counseling based on the Transtheoretical model on postpartum women between the ages of 18-45 will be evaluated.

02

Conditions studied

  • Birth Control Behavior
  • Reproductive Health Attitude

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03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's enrollment of 80 is below the median of 120 across 1,197 interventional studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 699 studies on the registry; 213 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primiparous women between the ages of 18-45
  • Women in the pre-discharge period, maximum 72 hours after normal birth or cesarean section

Exclusion criteria

Exclusion Criteria:

  • Women who do not want to use methods
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Experimental Arm Title: TTM-Based Postpartum Contraceptive Counseling

    The study included women aged 18-45 who had given birth for the first time (primiparous), were within 72 hours of delivery and at the stage of discharge, and were considering using a contraceptive method in the future. A total of 80 women meeting the sampling criteria were randomly assigned to either the intervention group (n=30) or the control group (n=50). While the intervention group received contraceptive counseling based on the Transtheoretical Model.

    Behavioral: Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive Uptake

  • No intervention
    Control Arm Title: Standard Postpartum Care

    The control group received routine postpartum care services at the clinic.

Interventions

  • BehavioralEffect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive Uptake

    The study included women aged 18-45 who had given birth for the first time (primiparous), were within 72 hours of delivery and at the stage of discharge, and were considering using a contraceptive method in the future. A total of 80 women meeting the sampling criteria were randomly assigned to either the intervention group (n=30) or the control group (n=50). Data collection forms were completed through face-to-face interviews. While the intervention group received contraceptive counseling based on the Transtheoretical Model, the control group received routine postpartum care services at the clinic. Contraceptive method usage was assessed via telephone at the 6- and 12-month marks for both groups, and at the end of the 12-month period, the "Contraceptive Methods Knowledge Test" (KYIBT) was administered to measure knowledge regarding contraceptive methods.

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What researchers measure

Primary outcomes

  1. 34-Question Family Planning Attitude Scale

    A minimum of 34 points and a maximum of 170 points can be obtained from the scale. A high score from the scale indicates that the individual's attitude towards Family Planning is positive.

    Time frame: Throughout the approximately one-year period during which the study was conducted

  2. Knowledge Test on Contraceptive Methods

    It was prepared by researchers and consists of 10 questions designed to evaluate women's knowledge levels about contraceptive methods, and the maximum score that can be obtained from the test is 10.

    Time frame: Throughout the approximately one-year period during which the study was conducted

07

Study locations

2 sites
  • Üsküdar Üniversitesi Çarşı Yerleşke
    Istanbul, Üsküdar 34660, Turkey (Türkiye)
  • Üsküdar Üniversitesi
    Istanbul, Üsküdar 34660, Turkey (Türkiye)
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References and documents

Publications

  • [1] World Health Organization. Contraception [Internet]. 2022 [cited 2026 Aug 12]. Available from: https://www.who.int/health-topics/contraception#tab=tab_1 [2] Yacobson I, Christopherson K, Michaelides T. Family Planning Methods. In: Finger B, editor. Facts for Family Planning. Washington, DC: USAID; 2013. p.6. ISBN: 978-0-9894734-0-8. Available from: https://fphandbook.org/sites/default/files/fffpchapter7.pdf [3] Hotun Şahin N. Family Planning and Infertility. In: Çoşkun MA, editor. Women's Health and Diseases Nursing Handbook. Istanbul: Koç University Publications; 2016. p.353. [4] World Health Organization. Family planning contraception [Internet]. 2023 [cited 2026 Aug 12]. Available from: https://www.who.int/news-room/fact-sheets/detail/family-planning-contraception [5] World Health Organization. Family planning/contraception methods [Internet]. 2020 [cited 2026 Aug 12]. Available from: https://www.who.int/news-room/factsheets/detail/family-planningcontraception (who.int in Bing) [6] Bellizzi S, Mannava P, Nagai M, Sobel HL. Reasons for discontinuation of contraception among women with a current unintended pregnancy in 36 low and middle-income countries. Contraception. 2020;101:26-33. doi:10.1016/j.contraception.2019.09.006 [7] Türkiye Nüfus ve Sağlık Araştırması (TNSA) 2013 [Internet]. Hacettepe Üniversitesi Nüfus Etütleri Enstitüsü; 2013 [cited 2026 Aug 12]. Available from: http://www.hips.hacettepe.edu.tr/tnsa2013/rapor/TNSA_2013_ana_rapor.pdf [8] Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018;98(3):228-31. [9] Whitaker AK, Chen BA. Society of family planning guidelines: Postplacental insertion of intrauterine devices. Contraception. 2018;97(1):2-13. [10] Danis RB. Contraception for the Postpartum Period. In: Shoupe D, editor. The Handbook of Contraception: Evidence Based Practice Recommendations and Rationales. Cham: Humana Press; 2020. p.337-44.

Individual participant data

Plan to share: Yes — Following the statistical analysis of the study results, they will be presented in the form of a statistical analysis report.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: Information will be shared following the completion of the work.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Jun 2024, 29 months.

Of 741 non-industry interventional studies with no phase under Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's 29 months is above that.

Counting every sponsor, half of 757 studies reached it within 13 months; a quarter within 5 and three quarters within 32.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2024
First posted
Aug 25, 2026
StartActual
Dec 21, 2021
Primary completionActual
Jun 11, 2024
CompletionActual
Jun 11, 2024
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07784738
Responsible party
Esra Tavukçu (Principal investigator, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Aug 25, 2026
Start date
Dec 21, 2021
Primary completion
Jun 11, 2024
Completion
Jun 11, 2024
Last update
Aug 25, 2026

Study contacts

Nevin ŞAHİN
study director · Danışman

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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