NCT07784738

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2021

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 23, 2024

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2024

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

August 25, 2026

Completed
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

2.5 years

First QC Date

May 23, 2024

Last Update Submit

August 24, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

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

Study Arms (2)

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.

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.

Interventions

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.

Experimental Arm Title: TTM-Based Postpartum Contraceptive Counseling

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimiparous women in the postpartum period were included
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Women who do not want to use contraceptive methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Üsküdar Üniversitesi Çarşı Yerleşke

Istanbul, Üsküdar, 34660, Turkey (Türkiye)

Location

Üsküdar Üniversitesi

Istanbul, Üsküdar, 34660, Turkey (Türkiye)

Location

Related Publications (1)

  • [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.

    RESULT

Study Officials

  • Nevin ŞAHİN

    Danışman

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is an educational intervention study with a pretest-posttest control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 23, 2024

First Posted

August 25, 2026

Study Start

December 21, 2021

Primary Completion

June 11, 2024

Study Completion

June 11, 2024

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

Following the statistical analysis of the study results, they will be presented in the form of a statistical analysis report.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Information will be shared following the completion of the work.

Locations