NCT07799545

Brief Summary

Considering the increasing rates of cesarean delivery in Turkey, we aimed to research the impact of antenatal education on pregnancy, the childbirth process, the cesarean section rate, and the postpartum period through a randomized controlled study. METHOD: A total of 120 pregnant women (40 in the education group and 80 in the control group) with a gestational age of 28 weeks or more were included in the study from the Üsküdar. The education group trained face to face in the Childbirth Preparation Class. Only if, pre- and post-training tests were administered to the education group to evaluate sociodemographic characteristics, educational needs, birth preferences, satisfaction with the training, and the behavioral outcomes gained from the training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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 1, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

4 days

First QC Date

August 23, 2026

Last Update Submit

August 27, 2026

Conditions

Keywords

Antenatal educationCesarean sectionNormal delivery

Outcome Measures

Primary Outcomes (1)

  • Comparison of the mode of delivery and the institution where the birth hospital

    Data Collection: The age, number of telephone consultations/information sessions, preferred hospital type (public/private), and final delivery method (normal/cesarean) of the participants in both groups were recorded. In addition, socio-demographic data (age, education, income, occupation, spouse's age, etc.), birth preferences (normal/vaginal or cesarean), 10 questions (1-5 scale) asking why they preferred normal delivery, 8 questions (1-5 scale) asking why they preferred cesarean delivery, and factors influencing their birth preference were recorded before the training. After the training, qualitative and quantitative data, including open-ended questions on the training needs and satisfaction of the study group, were recorded.

    through study completion, an average of 6 months.

Study Arms (2)

Antenatal education

EXPERIMENTAL

40 pregnant women who were selected according to the inclusion and exclusion criteria and who had completed Childbirth Preparation Class formed the intervention group. Then, the pregnant women who registered in our system have been given numbers. They have been sequentially numbered using a method that employs a central computer mechanism to implement the random assignment sequence. From these numbers, 80 people were selected using a single-blind random sampling method. Records of selected pregnant women were enrolled in the control group, with an allocation ratio of 1:2. In addition, a semi-structured questionnaire was administered to the intervention group before and after the training. The pre- and post-training questionnaire results of the pregnant women in this group were analyzed to investigate the effects of the training on birth preference, fear of childbirth, behavioral sociodemographic data, satisfaction rate with the training, fear of childbirth and breastfeeding-infantcare

Other: Antenatal education

Control group

NO INTERVENTION

The age, number of telephone consultations/information sessions, preferred hospital type (public/private), and final delivery method (normal/cesarean) of the participants in both groups were recorded.

Interventions

Pregnancy Information Class Pregnancy information training is conducted by a family medicine specialist and a midwife using the Ministry of Health's current guidelines and presentations provided as training material, with theoretical instruction and one-on-one question-and-answer sessions. The training lasts a total of 4 hours in two sessions per day.

Antenatal education

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Years over 18.
  • Pregnancy over 28 weeks (primiparous).
  • To live in Üsküdar.
  • No additional diseases that may affect maternal and neonatal outcomes.

You may not qualify if:

  • Patients with high-risk pregnancies.
  • Patients with maternal comorbidities (gestational hypertension, preeclampsia, uncontrolled diabetes or gestational diabetes, malignancy, vascular diseases, degenerative joint and connective tissue diseases, mental illness).
  • Women with known chronic disease.
  • Have a history of cesareans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık bilimleri üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy ComplicationsBreast Feeding

Interventions

Prenatal Education

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient Education as TopicHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Emrullah ŞANLAN, 2

    Saglik Bilimleri Universitesi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2026

First Posted

September 2, 2026

Study Start

December 1, 2025

Primary Completion

December 5, 2025

Study Completion

May 1, 2026

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations