Birth Control BehaviorNCT07784738
Transtheoretical Model Counseling in Postpartum Contraception
A study testing Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive Uptake in people with Birth Control Behavior and Reproductive Health Attitude, run by Istanbul University - Cerrahpasa at 2 sites in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Control Behavior, Reproductive Health Attitude
- What is being tested?
- Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive Uptake
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 21 Dec 2021to 11 Jun 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous women between the ages of 18-45
- Women in the pre-discharge period, maximum 72 hours after normal birth or cesarean section
Who cannot join
- Women who do not want to use contraceptive methods
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Üsküdar Üniversitesi Çarşı Yerleşke
Istanbul, Üsküdar, 34660
Üsküdar Üniversitesi
Istanbul, Üsküdar, 34660
About this study
Official title: The Effect of Postpartum Contraceptive Method Counseling Based on the Transtheoretical Model on Contraceptive Method Use
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.
- Being tested
- Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive Uptake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive UptakeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm Title: TTM-Based Postpartum Contraceptive Counseling | Experimental | 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. Receives: Behavioral: Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive Uptake |
| Control Arm Title: Standard Postpartum Care | No intervention | The control group received routine postpartum care services at the clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the approximately one-year period during which the study was conducted
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.
Measured: Throughout the approximately one-year period during which the study was conducted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start21 Dec 2021
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth Control BehaviorStudies of the same condition, open and under way.
- 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
- Model description
- This study is an educational intervention study with a pretest-posttest control group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Tavukçu, Istanbul University - Cerrahpasa
- Investigators
- Nevin ŞAHİN, Study director, Danışman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784738
- Sponsor's protocol ID
- 2022-11
- Status last verified
- Aug 2026
- First submitted
- 23 May 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following the statistical analysis of the study results, they will be presented in the form of a statistical analysis report.
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Postpartum Contraceptive Method Counseling Based on the Transtheoretical Model on Contraceptive Method Use
- ClinicalTrials.gov ID
- NCT07784738
- Acronym / sponsor ID
- 2022-11
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 25 Aug 2026 (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 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This study is an educational intervention study with a pretest-posttest control group.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm Title: TTM-Based Postpartum Contraceptive Counseling | Experimental | Behavioral: Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive UptakeThe 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. |
| Control Arm Title: Standard Postpartum Care | No intervention | –The control group received routine postpartum care services at the clinic. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Primiparous women between the ages of 18-45
- Women in the pre-discharge period, maximum 72 hours after normal birth or cesarean section
Key exclusion criteria (1 listed)
- Women who do not want to use contraceptive methods
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 |
|---|---|---|
| Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive UptakeThe 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. | Behavioural | Experimental Arm Title: TTM-Based Postpartum Contraceptive Counseling |
Primary outcome
34-Question Family Planning Attitude Scale
Time frame: Throughout the approximately one-year period during which the study was conducted
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.
Knowledge Test on Contraceptive Methods
Time frame: Throughout the approximately one-year period during which the study was conducted
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.
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 25 Aug 2026.
- Results publication[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 dataSharing planned: Yes. Following the statistical analysis of the study results, they will be presented in the form of a statistical analysis report.
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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.
Nevin ŞAHİN study director
Danışman
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Transtheoretical Model-Based Counseling on Postpartum Contraceptive Uptake in people with Birth Control Behavior and Reproductive Health Attitude, run by Istanbul University - Cerrahpasa at 2 sites 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 2 inclusion and 1 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
34-Question Family Planning Attitude Scale (time frame: Throughout the approximately one-year period during which the study was conducted). The study lists 2 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 NCT07784738, which also lists 1 linked publication.
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 25 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.