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Childbirth Preparation TrainingNCT07436468

Childbirth Preparation and Counseling Training

A study testing Basic Education and Counseling in people with Childbirth Preparation Training and Counseling, run by Biruni University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized controlled study was conducted to determine the effect of childbirth preparation and counseling training provided during pregnancy on adaptation to the pregnancy and childbirth process. This study with primiparous women school at a public hospital in Istanbul. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Childbirth Preparation Training, Counseling
What is being tested?
Basic Education and Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2024to 31 Oct 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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age over 18 years,
  • Primiparous status
  • Singleton pregnancy at 20-30 gestational weeks
  • Voluntary participation in the study.

Who cannot join

  • Diagnosis of high-risk pregnancy
  • Diagnosed fetal anomaly
  • Having conceived through infertility treatment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Biruni University

    Istanbul, Zeytinburnu, 34051

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Childbirth Preparation and Counseling Training During Pregnancy on Adaptation to Pregnancy and Childbirth

This is a randomized controlled study was conducted to determine the effect of childbirth preparation and counseling training provided during pregnancy on adaptation to the pregnancy and childbirth process.

This study with primiparous women school at a public hospital in Istanbul. A total of 110 pregnant women were divided into the Basic Education and Counseling Group (BECG; n=55) and the Basic Education Group (BEG; n=55). The BECG received childbirth preparation education plus counseling, while the BEG received only childbirth preparation education.

Read the detailed description

This is a randomized controlled study. The research was carried out in at a public hospital in Istanbul. This study was conducted at the pregnancy school affiliated with Health Sciences University Haseki Training and Research Hospital in Istanbul, Turkey, between 01 March 2024 and 31 October 2024. The study population consisted of primiparous pregnant women between 20-30 gestational weeks who applied to the pregnancy school.

Research Hypotheses H1: Childbirth preparation education has an effect on pregnancy adaptation. H2: Childbirth preparation education and counseling have an effect on pregnancy adaptation.

H3: Educational status has an effect on participation in childbirth preparation education.

H4: Childbirth preparation education has an effect on reducing fear of childbirth.

H5: Childbirth preparation education and counseling have an effect on reducing fear of childbirth.

Implementation:

Eligible participants who consented were randomized into the BECG and BEG groups. In the first phase, both groups completed the Demographic Information Form, PSAS, and W-DEQ-A. Participants attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. This education was routinely provided to both groups at the hospital's pregnancy school, and participants who did not maintain attendance were excluded from the study.

For the BECG, telephone numbers were collected, and participants were provided with a contact number for counseling services. In the second phase, BECG participants received telephone counseling 1-2 times monthly until gestational week 37. Questions asked during counseling were recorded in the Demographic Information Form. The BEG received no intervention during this phase. In the third phase, participants who reached gestational week 37 were contacted, and the relevant sections of the Demographic Information Form, PSAS, and W-DEQ-A were re-administered.

Childbirth Preparation Education Program

  1. nd SESSION: PREGNANCY AND NUTRITION Anatomy and function of reproductive organs Hormones Menstrual cycle Fertilization Ectopic pregnancy-twin pregnancy Changes that may occur in the body during pregnancy Smoking, alcohol, and drug use during pregnancy Clothing during pregnancy Working life during pregnancy Sexuality during pregnancy Nutrition during pregnancy Warning signs during pregnancy Travel during pregnancy Timing of pregnancy checkups Tetanus vaccination during pregnancy Blood type incompatibility Tests to be performed during pregnancy Emotional changes during pregnancy Growth and development of the baby in the womb Exercises to be performed during pregnancy
  2. nd SESSION: BIRTH AND BREATHING EXERCISES Birth preparation plan Signs indicating the onset of labor What to expect when going to the hospital for birth Stages of labor Breathing techniques (practical) Pain management techniques used during birth (practical) Exercises to do during pregnancy and childbirth (hands-on) Massages (hands-on) Interventional births
  3. nd SESSION: BREAST MİLK AND BREASTFEEDİNG TECHNİQUES - NEWBORN CARE Properties and benefits of breast milk Breastfeeding status worldwide and in Turkey Structure of the breasts Duration and reasons for breastfeeding Breastfeeding mechanism Breastfeeding technique (practical) Breastfeeding and medication use Breast care (practical) Factors that decrease and increase breast milk How to determine breast milk adequacy? Problems that may arise during breastfeeding and their solutions How to express and store breast milk (practical) Procedures performed on the newborn immediately after birth Newborn characteristics/appearance Problems seen in the newborn period Umbilical cord care (practical) Baby bath (practical) Baby clothing (practical) Baby's urine and stool Choosing baby diapers Diaper changing (practical) Nail cutting (practical) Newborn screening tests Hearing test Technique for measuring body temperature with a thermometer Sleeping positions (practical) Communicating with the baby Baby massage (practical) The baby's room Newborn baby safety Baby's registration procedures Well-child checkups Vaccinations
  4. nd SESSION: POSTNATAL PERIOD AND FAMILY PLANNING Postnatal period Postpartum bleeding and abdominal massage (practical) When to go to the toilet and get up Rest First breastfeeding Postpartum hygiene, stitches Postpartum checkups Nutrition Medication use Sexuality Emotional changes Postpartum exercises (practical) Postpartum care after cesarean section Postpartum contraception
Being tested
Basic Education and Counseling
Keywords
childbirth preparation training, counseling, pregnancy adaptation, fear of childbirth, prenatal education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Basic Education and CounselingBehavioural

    Description: The Basic Education and Counseling Group (BECG) participants, attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. This education was routinely provided at the hospital's pregnancy school, and participants who did not maintain attendance were excluded from the study. Ayrıca, the BECG, telephone numbers were collected, and were provided with a contact number for counseling services. BECG participants received telephone counseling 1-2 times monthly until gestational week 37.

Study groups in NCT07436468
Study groupRoleWhat they receive
Basic Education and Counseling Group (BECG)ExperimentalThe Basic Education and Counseling Group (BECG) participants, attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. This education was routinely provided at the hospital's pregnancy school, and participants who did not maintain attendance were excluded from the study. Ayrıca, the BECG, telephone numbers were collected, and were provided with a contact number for counseling services. BECG participants received telephone counseling 1-2 times monthly until gestational week 37.
Receives: Behavioral: Basic Education and Counseling
No intervention: Control GroupNo interventionThe Basic Education Group (BEG), participants attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. BEG, did not receive any intervention or consultancy services other than the education program.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Educational level of pregnant women

    Pregnant women were asked whether their level of education had an impact on their participation in childbirth preparation classes. The educational levels of pregnant women were surveyed as primary school and below, high school, or college and above.

    Measured: In the first phase, both groups completed this questionnaire.

Secondary outcomes (1)
  1. Prenatal Self-Assessment Scale (PSAS)

    PSAS was developed to measure adaptation to pregnancy and childbirth during the prenatal period. The scale is a structured assessment tool consisting of 79 items rated on a 4-point Likert format (4=does not describe at all, 3=somewhat describes, 2=partially describes, 1=very much describes). Forty-seven items are reverse-scored, and no cut-off point exists. The PSAS contains seven subscales: maternal-fetal health perception, acceptance of pregnancy, internalization of motherhood role, readiness for labor, fear of childbirth, relationship with mother, and relationship with spouse. Total scores range from 79-316, with lower scores indicating optimal maternal adaptation. In this study, the global Cronbach's α was 0.84, with subscale values ranging from 0.73-0.83.

    Measured: In the first phase, both groups completed the PSAS. In the third phase, participants who reached gestational week 37 were contacted, and PSAS were re-administered.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start1 Mar 2024
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

Resources

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
Single group
Model description
Single Group Assignment The study included 110 pregnancy to pregnancy school affiliated with Health Sciences University Haseki Training and Research Hospital in Istanbul who consented to participate. Participants were randomized into two groups: the Basic Education and Counseling Group (BECG; n=55) and the Basic Education Group (BEG; n=55). All participants attended childbirth preparation education consisting of four weekly sessions of 4 hours each, totaling 16 hours over one month. This education participants who did not maintain attendance were excluded from the study. For the BECG, telephone numbers were collected, and participants were provided with a contact number for counseling services. In the second phase, BECG participants received telephone counseling 1-2 times monthly until gestational week 37. Questions asked during counseling were recorded in the Demographic Information Form. The BEG received no intervention during this phase.
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07436468
Sponsor's protocol ID
2023/83-07
Status last verified
Feb 2026
First submitted
9 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We did not obtain permission from the participants to share their data with other researchers.

Publications

  • 32. Uğuz Y, Karaçam Z. The effect of childbirth preparation education on women's delivery mode and views on childbirth. Adnan Menderes University Faculty of Health Sciences Journal. 2022;6(3).

  • Halvorsen L, Nerum H, Sorlie T, Oian P. Does counsellor's attitude influence change in a request for a caesarean in women with fear of birth? Midwifery. 2010 Feb;26(1):45-52. doi: 10.1016/j.midw.2008.04.011. Epub 2008 Jul 14.

    PubMed 18621452
  • 30. Buran G, Olgaç Z, Karaçam Z. The effect of childbirth preparation classes on women's delivery mode, fear, and experience: Systematic review. Life Sciences. 2020;15(4).

  • 29. Esencan TY, Karabulut Ö, Yıldırım AD, et al. Delivery mode, first breastfeeding time, and skin-to-skin contact preferences of pregnant women receiving childbirth preparation education. Florence Nightingale Journal of Nursing. 2018;26(1):31-43.

  • Soysal C, Ulas O, Isikalan MM, Biyik I, Tasci Y, Keskin N. The changes in fear of childbirth in pregnancy during and before the COVID-19 pandemic. Sci Rep. 2024 May 14;14(1):11067. doi: 10.1038/s41598-024-61307-9.

    PubMed 38744899
  • Dai L, Shen Q, Redding SR, Ouyang YQ. Simulation-based childbirth education for Chinese primiparas: A pilot randomized controlled trial. Patient Educ Couns. 2021 Sep;104(9):2266-2274. doi: 10.1016/j.pec.2021.02.036. Epub 2021 Feb 19.

    PubMed 33663905
  • 26. Subaşı B, Özcan H, Pekçetin S, et al. Effects of delivery education on childbirth anxiety and fear. Selçuk Medical Journal. 2013;29(4):165-167.

  • 25. Barut S, Uçar T. The relationship between birth self-efficacy perception and fear of childbirth in pregnant women. Mersin University Journal of Health Sciences. 2018;11(2):107-115.

  • 24. Akın B, Yeşil Y, Yücel U, et al. Effect of education given in prenatal education classes on pregnant women's fear of childbirth level. Life Sciences. 2018;13(2):11-20.

  • Cankaya S, Simsek B. Effects of Antenatal Education on Fear of Birth, Depression, Anxiety, Childbirth Self-Efficacy, and Mode of Delivery in Primiparous Pregnant Women: A Prospective Randomized Controlled Study. Clin Nurs Res. 2021 Jul;30(6):818-829. doi: 10.1177/1054773820916984. Epub 2020 Apr 13.

    PubMed 32281410
  • Doaltabadi Z, Amiri-Farahani L, Hasanpoor-Azghady SB. Implementation of Virtual and Face-to-Face Childbirth Preparation Training for the Spouses of the Primiparous Women to Reduce the Fear of Childbirth, Improve the Pregnancy Experience, and Enhance Mother- and Father-Infant Attachment: Protocol for a Quasiexperimental Clinical Trial. Obstet Gynecol Int. 2021 Apr 11;2021:6686934. doi: 10.1155/2021/6686934. eCollection 2021.

    PubMed 33936209
  • Hofberg K, Brockington I. Tokophobia: an unreasoning dread of childbirth. A series of 26 cases. Br J Psychiatry. 2000 Jan;176:83-5. doi: 10.1192/bjp.176.1.83.

    PubMed 10789333
  • Sercekus P, Baskale H. Effects of antenatal education on fear of childbirth, maternal self-efficacy and parental attachment. Midwifery. 2016 Mar;34:166-172. doi: 10.1016/j.midw.2015.11.016. Epub 2015 Nov 27.

    PubMed 26656473
  • 14. Yılmaz E. Effects of antenatal pregnancy education on birth and postpartum period [Doctoral dissertation]. Ankara: Gazi University Faculty of Health Sciences; 2019.

  • 13. Yılmaz AN, Yüksekol ÖD, Baltacı N, et al. Examining the relationship between physiological complaints, quality of life, and pregnancy adaptation in pregnancy: A university hospital example. Mersin University Medical Faculty Lokman Hekim Journal. 2023;13(2):408-418.

Questions about this trial

What is this clinical trial studying?

A study testing Basic Education and Counseling in people with Childbirth Preparation Training and Counseling, run by Biruni University at 1 site 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 4 inclusion and 3 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Educational level of pregnant women (time frame: In the first phase, both groups completed this questionnaire.). 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 NCT07436468, which also lists 26 linked publications.

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 27 Feb 2026.

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