NCT07659249

Brief Summary

Objective: This study was designed to evaluate the effect of perineal mirror use during the second stage of labor on the duration of the second stage, postpartum recovery, and perceived pain, support, and control levels during delivery. Method: The study was designed as a randomized controlled experimental study to examine the effect of perineal mirror use on delivery outcomes in primiparous women. The study population consisted of primiparous pregnant women admitted to the maternity clinic between June 29, 2026, and October 30, 2026. The sample size was calculated using the G\*Power 3.1.9.2 program with an effect size of 0.50, 5% Type I error, and 95% power level; a total of 72 participants were selected, 36 in the intervention group and 36 in the control group. Considering potential losses, the sample size was increased by 10%, and a total of 80 pregnant women were planned to be included in the study. Participants were randomly assigned to the intervention group using a perineal mirror and the control group receiving routine care. The following instruments will be used as data collection tools: Pregnancy Demographic Information Form, REEDA Scale, Visual Analog Scale (VAS), and Perceived Support and Control in Childbirth Scale. Expected Outcome: It is predicted that the perineal mirror may increase the woman's active participation, motivation, and perceived control by allowing her to see the fetal descent and the progress of labor; consequently, it may reduce the duration of active pushing and the duration of the second stage. It is also thought that it may have positive effects on the birth experience, postpartum recovery, and perceived level of support and control. The research results are expected to provide evidence for non-invasive and low-cost applications that can be used in childbirth care.

Trial Health

63
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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
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress27%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

June 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

June 29, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 16, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

MidwiferyPerineal mirrorSecond stage of laborVaginal birthPrimiparous womenLabor durationChildbirth painPerceived supportPerceived controlREEDA scaleMaternal outcomesNon-invasive intervention

Outcome Measures

Primary Outcomes (1)

  • Duration of the Second Stage of Labor

    Duration of the second stage of labor, measured in minutes from complete cervical dilatation to birth.

    During labor (second stage of labor)

Study Arms (2)

Perineal Mirror Group

EXPERIMENTAL

Participants in this group will receive perineal mirror use during the active pushing phase of the second stage of labor in addition to routine intrapartum care. The mirror will be positioned to allow visualization of fetal descent and birth progress.

Device: Perineal Mirror

Routine Care Group

NO INTERVENTION

Participants in this group will receive routine intrapartum care during labor without perineal mirror use.

Interventions

A perineal mirror will be positioned at the foot of the delivery bed during the active pushing phase of the second stage of labor. The mirror will allow the woman to visualize fetal descent and birth progress while continuing routine intrapartum care. The intervention is non-invasive, does not alter standard clinical management, and is intended to enhance maternal participation, motivation, perceived control, and support during childbirth.

Perineal Mirror Group

Eligibility Criteria

Age19 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women are eligible to participate because the study investigates the effects of perineal mirror use during the second stage of labor among primiparous pregnant women undergoing vaginal birth.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women aged 19 and over
  • Women with term pregnancy (38+0 - 41+6)
  • Women with singleton pregnancy
  • Women who have had spontaneous vaginal delivery
  • Primiparous pregnant women
  • Women who voluntarily agree to participate in the study will be included.

You may not qualify if:

  • Women with high-risk pregnancies
  • Women with multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Düzce Atatürk State Hospital

Düzce, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

MELEK BALÇIK ÇOLAK, MSc, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking will be used in this study. Participants, care providers, investigators, and outcome assessors will be aware of group assignments because the perineal mirror intervention is visible and cannot be concealed during labor.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel groups. Women in the intervention group will receive perineal mirror use during the active pushing phase of the second stage of labor in addition to routine intrapartum care. Women in the control group will receive routine intrapartum care only. Outcomes related to the duration of the second stage of labor, postpartum perineal healing, perceived pain, perceived support, and perceived control during childbirth will be compared between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

June 16, 2026

First Posted

June 22, 2026

Study Start

June 29, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Locations