Labor, Second StageNCT07659249
USE OF PERINEAL MIRROR DURING THE SECOND STAGE OF LABOR
A study testing Perineal Mirror in people with Labor, Second Stage and Vaginal Delivery, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor, Second Stage, Vaginal Delivery, Primiparity
- What is being tested?
- Perineal Mirror
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jun 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Women with high-risk pregnancies
- Women with multiple pregnancies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Düzce Atatürk State Hospital
Düzce
Nurşen BAYRAM AYBEY, +90 534 692 7151, nursen.bayram1@ogr.sakarya.edu.tr
About this study
Official title: THE EFFECT OF PERİNEAL MİRROR USE DURİNG THE SECOND STAGE OF LABOR ON THE DURATİON OF THE SECOND STAGE, RECOVERY, AND PERCEİVED PAİN, SUPPORT, AND CONTROL LEVELS DURİNG DELİVERY
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.
- Conditions
- Labor, Second Stage, Vaginal Delivery, Primiparity, Perineal Mirror Use, Childbirth Experience, Labor Pain
- Being tested
- Perineal Mirror
- Keywords
- Midwifery, Perineal mirror, Second stage of labor, Vaginal birth, Primiparous women, Labor duration, Childbirth pain, Perceived support, Perceived control, REEDA scale, Maternal outcomes, Non-invasive intervention
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineal MirrorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Perineal Mirror |
| Routine Care Group | No intervention | Participants in this group will receive routine intrapartum care during labor without perineal mirror use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the Second Stage of Labor
Duration of the second stage of labor, measured in minutes from complete cervical dilatation to birth.
Measured: During labor (second stage of labor)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start29 Jun 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, Second StageStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, melek balcikcolak, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07659249
- Sponsor's protocol ID
- E-43012747-050.04-579687-319
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF PERİNEAL MİRROR USE DURİNG THE SECOND STAGE OF LABOR ON THE DURATİON OF THE SECOND STAGE, RECOVERY, AND PERCEİVED PAİN, SUPPORT, AND CONTROL LEVELS DURİNG DELİVERY
- ClinicalTrials.gov ID
- NCT07659249
- Acronym / sponsor ID
- E-43012747-050.04-579687-319
- Conditions
- Labor, Second Stage, Vaginal Delivery, Primiparity, Perineal Mirror Use, Childbirth Experience, Labor Pain
- Keywords
- Midwifery, Perineal mirror, Second stage of labor, Vaginal birth, Primiparous women, Labor duration, Childbirth pain, Perceived support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 29 Jun 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Perineal Mirror Group | Experimental | Device: Perineal MirrorParticipants 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. |
| Routine Care Group | No intervention | –Participants in this group will receive routine intrapartum care during labor without perineal mirror use. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Women with high-risk pregnancies
- Women with multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineal MirrorA 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. | Device | Perineal Mirror Group |
Primary outcome
Duration of the Second Stage of Labor
Time frame: During labor (second stage of labor)
Duration of the second stage of labor, measured in minutes from complete cervical dilatation to birth.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineal Mirror in people with Labor, Second Stage and Vaginal Delivery, run by Sakarya 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 6 inclusion and 2 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: opening soon, as of the sponsor's last update on 22 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MELEK BALÇIK ÇOLAK, MSc, Assoc. Prof. (+90 264 295 3881, mbalcikcolak@sakarya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the Second Stage of Labor (time frame: During labor (second stage of labor)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026.