NCT07112495

Brief Summary

Labor pain causes women to be afraid of vaginal delivery and to be anxious about delivery and therefore to prefer cesarean delivery (Ali Alahmari et al., 2020). The World Health Organization (WHO) has set the safe cesarean section rate for countries at 15% (World Health Organization, 2015). However, many countries are well above this rate (Betran et al., 2021). An important factor in the preference for cesarean deliveries is the fear of vaginal delivery (Zhao et al., 2021). Vaginal delivery with epidural anesthesia in primiparous women is a very good opportunity to prevent the preference of cesarean deliveries due to fear of vaginal delivery. Unless contraindicated, epidural analgesia should be offered to women to alleviate the pain felt with contractions during labor (Callahan et al., 2023). Recently, women frequently prefer epidural anesthesia to avoid pain during vaginal delivery. Vaginal delivery with epidural anesthesia aims to minimize the pain of women during the trauma process and is the most effective pain method among pharmacological and nonpharmacological interventions (Antonakou, \& Papoutsis, 2016). The reason why vaginal delivery with epidural anesthesia is not widespread enough is that women are not given enough information about epidural anesthesia (Shishido et al., 2020).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

May 14, 2025

Last Update Submit

December 28, 2025

Conditions

Keywords

pregnancypainburnoutbreastfeeding

Outcome Measures

Primary Outcomes (4)

  • To determine the breastfeeding self-efficacy levels of mothers.

    Assessed using the Breastfeeding Self-Efficacy Scale The minimum possible score on the scale is 14, and the maximum is 70. There is no cutoff point for the scale, and a higher score indicates higher breastfeeding self-efficacy.

    1 year

  • To evaluate maternal attachment levels.

    Measured with a validated maternal attachment scale. The lowest possible score on the scale is 26, and the highest is 104. A higher score indicates a higher level of maternal attachment.

    1 year

  • To examine the breastfeeding status of infants during the first six months of life.

    Including exclusive breastfeeding, partial breastfeeding, and formula supplementation

    1 year

  • To monitor infant growth and development through percentile tracking during the first six months.

    Based on weight, height, and head circumference measurements compared with growth charts

    1 year

Study Arms (2)

intervention

EXPERIMENTAL

pregnant women receiving epidural

Other: pregnant women with

Control

NO INTERVENTION

no pregnant women receiving epidural

Interventions

pregnant women with

intervention

Eligibility Criteria

Age19 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen in labor
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Having a normal vaginal delivery in the delivery room,
  • to 45 years old
  • To be transferred to the Puerperium service after delivery,
  • The baby's APGAR score is 7 and above
  • and above weeks of gestation
  • No complications in the baby and mother due to childbirth
  • Postnatal care by the mother's side
  • Mother and baby sharing the same room after birth until discharge,
  • The mother is breastfeeding her baby,
  • Mother's voluntary participation in the study.

You may not qualify if:

  • Separation of mother and baby for any reason while the mother is with the baby
  • Transfer of the baby to the NICU
  • Wanting to get out of the study.
  • Being a single parent
  • Those who cannot speak and write Turkish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University

Sakarya, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

PainBurnout, PsychologicalBreast Feeding

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsStress, PsychologicalBehavioral SymptomsBehaviorFeeding Behavior

Study Officials

  • Tiryaki

    Sakarya

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: This study was designed as a randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

May 14, 2025

First Posted

August 8, 2025

Study Start

January 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 20, 2025

Last Updated

January 2, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations