NCT07072507

Brief Summary

The research questions of this study are listed below.

  1. 1.Is the mean spouse support score of pregnant women who attend childbirth preparation education with their spouses higher than that of women in the group with unique participation in childbirth preparation education and the control group who were left to usual care?
  2. 2.Is the mean birth satisfaction scale score of pregnant women who attend childbirth preparation education with their spouses higher than that of women in the group with unique participation in childbirth preparation education and the control group who were left to usual care?
  3. 3.Is the mean birth memory and recall scale score of pregnant women who attend childbirth preparation education with their spouses higher than that of women in the group with unique participation in childbirth preparation education and the control group who were left to usual care?
  4. 4.Are the birth preferences of pregnant women who attend childbirth preparation education with their spouses significantly different from those of women in the group with unique participation in childbirth prep

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

June 28, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

June 27, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

Childbirth Education ClassesPartner SupportBirth MemoryBirth Satisfactionchoice of the birth method

Outcome Measures

Primary Outcomes (5)

  • Introduction form

    Participants will complete a five-question introduction form, including four sociodemographic questions and a question about birth preferences.

    During registration (first day)

  • Pre Education-Spousal Support During Pregnancy

    The Perception of Spousal Support in Pregnancy Scale (PSSPS) (22 questions) will be administered during registration. The lowest possible score from the total scale is 16, and the highest score is 80. High scores from the scale indicate that perceived spousal support during pregnancy is high, while low scores indicate that perceived spousal support is low.

    During registration (first day)

  • After Education - Spousal Support During Pregnancy

    The Perception of Spousal Support During Pregnancy Scale (PSSPS) (22 questions) will be administered after childbirth education . The lowest possible score from the total scale is 16, and the highest score is 80. High scores from the scale indicate high perceived spousal support during pregnancy, while low scores indicate low perceived spousal support.

    After education (When Childbirth Education is Finish)

  • Postpartum- Memories and Recall

    Birth memories and how he remembered his birth will be assessed with the "Birth Memories and Recall Questionnaire (BirthMARQ)" The scale has six sub-dimensions, and each sub-dimension is scored on its own. It is a 7-point Likert scale. Emotional memory sub-dimension: High scores in this dimension indicate having negative feelings about the birth experience. Ambiguous Emotional Memory Sub-dimension: High scores in this dimension indicate having more ambiguous feelings about the birth experience. Centrality of memory sub-dimension: High scores indicate that the birth memory is more centralized in the mother. Consistency and reliving sub-dimension: High scores in this dimension indicate a more consistent birth memory and more reliving. Sensory memory sub-scale: Higher scores indicate increased sensory memory of the birth experience. Involuntary recall sub-scale: Higher scores indicate more frequent involuntary recall.

    First week postpartum (during first clinical check-up)

  • Postpartum-Birth Satisfaction Scale Short Form (BSE-S)

    The Birth Satisfaction Scale Short Form (BSE-S), which uses a 5-point Likert scale, will be utilized to measure birth satisfaction. The scale ranges from a lowest score of 0 to a highest score of 40 points. As the score increases, so does the level of satisfaction. For this study, the cut-off scores have been divided into three equal parts as follows: * Low satisfaction level: less than 13 points * Medium satisfaction level: 14 to 27 points * High satisfaction level: 28 points or more

    First week postpartum (during first clinical check-up)

Secondary Outcomes (2)

  • Birth method preference

    During registration (first day)

  • Childbirth method

    First week postpartum (during first clinical check-up)

Study Arms (2)

Kontrol

NO INTERVENTION

Participants in the control group will not receive any intervention. They will be left to the clinic's usual care.

Education Group

EXPERIMENTAL

The training group will be divided into two categories: a partnerless education group and a partnered education group. Participants will receive 2 hours of weekly childbirth preparation training over the course of five weeks.

Behavioral: Chilbirth Education

Interventions

Participants divided into training groups will receive training on pregnancy, birth, breastfeeding, preparation for parenthood, and baby care in groups of 6-8 people, 2 hours a week for five weeks.

Education Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPhysiologically, pregnancy occurs with the female gender.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being able to speak and write Turkish
  • Nulliparous
  • Being in 30-32 weeks of pregnancy
  • Having a singleton pregnancy

You may not qualify if:

  • Having communication and psychological problems
  • Having multiple pregnancies
  • Being overweight and obese
  • Being divorced or having lost a spouse
  • Not attending more than one session of childbirth preparation classes with/without a spouse
  • Filling out incomplete forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University

Bursa, 16059, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Zamani P, Ziaie T, Lakeh NM, Leili EK. The correlation between perceived social support and childbirth experience in pregnant women. Midwifery. 2019 Aug;75:146-151. doi: 10.1016/j.midw.2019.05.002. Epub 2019 May 6.

    PMID: 31125906BACKGROUND
  • Arisukwu O, Igbolekwu CO, Oyekola IA, Oyeyipo EJ, Asamu FF, Osueke ON. Spousal support during pregnancy in the Nigerian rural context: a mixed methods study. BMC Pregnancy Childbirth. 2021 Nov 15;21(1):772. doi: 10.1186/s12884-021-04135-3.

    PMID: 34781883BACKGROUND

Central Study Contacts

Buran G Dr Buran, Asosc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be assigned to the non-spouse education group, the together spouse education group, and the clinic's usual care control group by simple randomization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asosc. Prof.

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 18, 2025

Study Start

June 28, 2025

Primary Completion

September 30, 2025

Study Completion

October 30, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Personal data can be shared only with the consent of the individuals involved. It can be shared if the participants have sharing approval.

Locations