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Labor and DeliveryNCT07874243

Effect of a Vertical Birthing Chair on Labor

A study testing Using a vertical birthing chair during the active second stage of labor in people with Labor and Delivery, run by Kartal City Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this randomized clinical trial is to evaluate whether the use of a vertical birthing chair during the active second stage of labor improves fetal head descent and rotation. Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Labor and Delivery
What is being tested?
Using a vertical birthing chair during the active second stage of labor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteTurkey (Türkiye)
Study dates
Oct 2026to Dec 2027
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 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant individuals aged 18-40 years
  • Gestational age between 37 weeks 0 days and 41 weeks 0 days
  • Singleton, live fetus
  • Cephalic fetal presentation
  • Planned vaginal delivery
  • Spontaneous or induced labor
Show all 9Show fewer
  • Full cervical dilatation at the time of randomization
  • Stable maternal and fetal clinical status
  • Provision of written informed consent to participate in the study

Who cannot join

  • History of previous cesarean delivery or other uterine surgery
  • Multiple pregnancy
  • Breech, transverse, or other non-cephalic fetal presentation
  • Placenta previa or vasa previa
  • Intrauterine fetal death
  • Known or suspected major fetal anomaly
Show all 10Show fewer
  • Development of an indication for emergency cesarean delivery before randomization
  • Severe preeclampsia or eclampsia
  • Orthopedic or neurological condition that prevents or makes the use of a vertical birthing position unsafe
  • Withdrawal of consent or unwillingness to participate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elif Unlugedik Sayin, MD, PhD contact

+905322348083

elif.unlugedik@gmail.com

Beyzanur Kahyaoglu, MD contact

+905547920352

bkahyaoglu89@gmail.com

Turkey (Türkiye)1 site
  • Kartal Dr Lütfi Kırdar Şehir Hastanesi

    Istanbul, Kartal

    Elif Unlugedik Sayın, MD, PhD, +905322348083, elif.unlugedik@gmail.com

    elif.unlugedik@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of a Vertical Birthing Chair on Fetal Head Descent and Rotation During the Second Phase of Labor: An Intrapartum Ultrasound-Based Randomized Study

The goal of this randomized clinical trial is to evaluate whether the use of a vertical birthing chair during the active second stage of labor improves fetal head descent and rotation. The effects will be assessed objectively by intrapartum ultrasonography, and effects on labor progress and maternal and neonatal outcomes. The main questions it aims to answer are:

  • Does the use of a vertical birthing chair improve intrapartum ultrasonographic parameters of fetal head descent and rotation compared with the standard semi-recumbent position?
  • Does the use of a vertical birthing chair affect the duration of the second stage of labor, mode of delivery, perineal injury, postpartum blood loss, maternal childbirth experience, and neonatal outcomes?
Read more

Researchers will compare women assigned to use a vertical birthing chair with women assigned to the standard semi-recumbent position to determine the effects of maternal position during the active second stage of labor.

Participants will:

  • Be randomly assigned to either the vertical birthing chair group or the standard semi-recumbent position group during the active second stage of labor.
  • Undergo intrapartum ultrasonographic assessment of fetal head descent and rotation.
  • Be evaluated for the duration and mode of delivery, episiotomy and perineal trauma, postpartum blood loss, and neonatal outcomes.
  • Complete the Childbirth Experience Questionnaire (CEQ) to assess their childbirth experience.
Read the detailed description

This prospective, randomized, controlled, parallel-group clinical trial will investigate the effects of using a vertical birthing chair during the active second stage of labor on fetal head descent and rotation, as objectively assessed by intrapartum ultrasonography. The study will also evaluate the effects of maternal position on the progression of labor, mode of delivery, maternal obstetric outcomes, childbirth experience, and neonatal outcomes.

The sample size was calculated using G*Power based on the expected between-group difference in the change in the Angle of Progression (AoP), the primary outcome of the study. Assuming a moderate effect size (Cohen's d = 0.50), a two-sided type I error rate of 5% (α = 0.05), and 80% statistical power, at least 64 participants will be required in each group. To account for an anticipated attrition or protocol-deviation rate of approximately 10%, 72 participants will be enrolled in each group, resulting in a total planned sample size of 144 participants.

At the beginning of the active second stage of labor, participants will be randomly assigned in a 1:1 ratio to either the vertical birthing chair group or the standard semi-recumbent position group. Computer-generated block randomization will be used to maintain balanced group sizes throughout recruitment. The randomization sequence will be prepared by an investigator who is independent of participant recruitment and clinical assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. Group allocation will be revealed only after the baseline intrapartum ultrasonographic assessment has been completed.

Participants allocated to the intervention group will be positioned on a vertical birthing chair after full cervical dilatation. The maternal trunk will be maintained at an inclination of approximately 60-90 degrees, with the feet adequately supported. Participants will be allowed to move within safe limits during labor. A change in position will be permitted when clinically required for maternal or fetal reasons and will be documented as a protocol deviation or crossover, as appropriate.

Participants allocated to the control group will be managed on a delivery bed in the standard semi-recumbent position, with the maternal trunk elevated approximately 30-45 degrees. In both groups, labor management will otherwise follow the hospital's routine obstetric practices. Fetal monitoring, oxytocin administration, analgesia, and any necessary obstetric interventions will be provided according to clinical indications. Decisions regarding operative vaginal delivery, cesarean delivery, episiotomy, or other interventions will be made by the attending clinical team based on maternal and fetal conditions.

All intrapartum ultrasonographic examinations will be performed by the same obstetrician experienced in intrapartum ultrasound to reduce interobserver variability. Fetal head position will be evaluated by transabdominal ultrasonography, whereas fetal head descent will be assessed by transperineal ultrasonography.

The following intrapartum ultrasonographic parameters will be recorded:

Angle of Progression (AoP) Head-Perineum Distance (HPD) Head-Symphysis Distance (HSD) Fetal head position, classified as occiput anterior, occiput transverse, or occiput posterior Fetal head rotation Presence of caput succedaneum Presence of molding

Ultrasonographic assessments will be performed at four predefined time points:

T0: At full cervical dilatation and before randomization T1: Fifteen minutes after initiation of the assigned maternal position T2: Thirty minutes after initiation of the assigned maternal position T3: Immediately before birth or when a decision for operative delivery is made

Each ultrasonographic parameter will be measured twice at each assessment, and the mean of the two measurements will be used in the statistical analyses. The principal ultrasonographic evaluation will focus on the change in AoP over time and the difference in this change between the intervention and control groups. Changes in HPD, HSD, and fetal head position or rotation will provide additional objective information regarding fetal head descent and rotational progress.

Participants' sociodemographic and obstetric characteristics will be recorded using a standardized case report form. These data will include maternal age, height, body weight, pre-pregnancy body mass index, gestational age at delivery, spontaneous or induced onset of labor, epidural analgesia, and oxytocin use.

Clinical labor and delivery data will include the duration of the active second stage, total duration of the second stage, mode of delivery, requirement for operative vaginal delivery, cesarean delivery, episiotomy, degree of perineal laceration, postpartum blood loss, and need for additional uterotonic medication.

Maternal childbirth experience will be assessed within the first 24 hours after birth using the validated Turkish version of the Childbirth Experience Questionnaire (CEQ). The questionnaire evaluates four dimensions of childbirth experience: Own Capacity, Professional Support, Perceived Safety, and Participation. Scores will be calculated for each domain and for the overall questionnaire, with higher scores indicating a more positive childbirth experience.

Neonatal assessments will include birth weight, Apgar scores at 1 and 5 minutes, umbilical artery pH, umbilical artery base deficit, and admission to the neonatal intensive care unit.

Study data will be entered into standardized case report forms and checked for completeness, accuracy, acceptable ranges, and internal consistency. Ultrasonographic findings and clinical outcomes will be verified against ultrasound records, labor monitoring documentation, and maternal and neonatal medical records. Missing, unavailable, uninterpretable, or out-of-range data will be identified and documented before analysis. Reasons for withdrawal, crossover, incomplete ultrasonographic assessment, or deviation from the assigned position will also be recorded.

The statistical analysis will follow a prespecified statistical analysis plan. Baseline characteristics will be summarized by randomized group. Repeated ultrasonographic measurements will be analyzed to assess changes over time and differences in these changes between the two groups. Maternal and neonatal outcomes will also be compared between the intervention and control groups using statistical methods appropriate to the distribution and measurement level of each variable. The principal analysis will be conducted according to the intention-to-treat principle; an additional per-protocol analysis may be performed to evaluate the findings among participants who remain in their assigned position according to the study protocol. Effect estimates will be reported with 95% confidence intervals, and a two-sided p value of <0.05 will be considered statistically significant.

Being tested
Using a vertical birthing chair during the active second stage of labor
Keywords
Vertical Birthing Chair, Labor Delivery, Childbirth Experience Questionnaire, Second Stage of Labor

What participants receive

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

  • Using a vertical birthing chair during the active second stage of laborOther

    In the intervention group, women will use a vertical birthing chair during the active second stage of labor.

Study groups in NCT07874243
Study groupRoleWhat they receive
Intervention arm- Vertical Birth Chair groupActive comparatorParticipants assigned to this arm will use a vertical birthing chair during the active second stage of labor. After full cervical dilatation, participants will be positioned and the feet adequately supported. Maternal movement within safe limits will be permitted. Intrapartum ultrasonographic assessments will be performed at baseline before randomization, and at 15 minutes, 30 minutes, and immediately before birth or when a decision for operative delivery is made. Routine obstetric care and fetal monitoring will continue throughout labor.
Receives: Other: Using a vertical birthing chair during the active second stage of labor
Control Arm-Standart Semi-sitting Position GroupNo interventionParticipants assigned to this arm will be managed in the standard semi-recumbent position during the active second stage of labor. After full cervical dilatation, participants will be positioned on a delivery bed with the trunk elevated at approximately 30-45 degrees. Intrapartum ultrasonographic assessments will be performed at baseline before randomization, at 15 and 30 minutes after initiation of the assigned position, and immediately before birth or when a decision for operative delivery is made. Routine obstetric care, fetal monitoring, oxytocin administration, analgesia, and any necessary obstetric interventions will be provided according to clinical indications.

What is being measured

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

  1. 1. Change in Angle of Progression From Baseline to 30 Minutes

    The Angle of Progression (AoP) will be measured in degrees using transperineal ultrasonography at full cervical dilatation before randomization (T0) and 30 minutes after initiation of the assigned maternal position (T2). Each measurement will be performed twice, and the mean of the two measurements will be used. The outcome will be calculated as the AoP at T2 minus the AoP at T0. A greater positive change indicates greater fetal head descent.

    Measured: From baseline at full cervical dilatation to 30 minutes after initiation of the assigned maternal position.

Secondary outcomes (17)
  1. Change in Angle of Progression From Baseline to 15 Minutes

    AoP will be measured in degrees by transperineal ultrasonography before randomization (T0) and 15 minutes after initiation of the assigned maternal position (T1). The mean of two measurements at each time point will be used. The outcome will be calculated as the AoP at T1 minus the AoP at T0. A greater positive change indicates greater fetal head descent.

    Measured: From baseline at full cervical dilatation to 15 minutes after initiation of the assigned maternal position.

  2. Change in Angle of Progression From Baseline to the Final Intrapartum Assessment

    AoP will be measured in degrees before randomization (T0) and immediately before birth or when a decision for operative delivery is made (T3). The mean of two measurements at each time point will be used. The outcome will be calculated as the AoP at T3 minus the AoP at T0. A greater positive change indicates greater fetal head descent.

    Measured: From baseline at full cervical dilatation to immediately before birth or the decision for operative delivery.

  3. Change in Head-Perineum Distance From Baseline to 30 Minutes

    Head-Perineum Distance (HPD) will be measured in millimeters using transperineal ultrasonography before randomization (T0) and 30 minutes after initiation of the assigned position (T2). Each measurement will be performed twice, and the mean value will be used. The outcome will be calculated as the HPD at T2 minus the HPD at T0. A greater reduction in HPD indicates greater fetal head descent.

    Measured: From baseline at full cervical dilatation to 30 minutes after initiation of the assigned maternal position.

  4. Change in Head-Symphysis Distance From Baseline to 30 Minutes

    Head-Symphysis Distance (HSD) will be measured in millimeters using transperineal ultrasonography before randomization (T0) and 30 minutes after initiation of the assigned position (T2). Each measurement will be performed twice, and the mean value will be used. The outcome will be calculated as the HSD at T2 minus the HSD at T0.

    Measured: From baseline at full cervical dilatation to 30 minutes after initiation of the assigned maternal position.

  5. Fetal Head Rotation to an Occiput Anterior Position

    Fetal head position will be assessed by transabdominal ultrasonography and classified as occiput anterior, occiput transverse, or occiput posterior. The outcome will be reported as the number and percentage of participants in whom the fetal head rotates from a non-occiput-anterior position at baseline to an occiput anterior position at the final intrapartum assessment.

    Measured: From baseline at full cervical dilatation to immediately before birth or the decision for operative delivery.

  6. Fetal Head Position at the Final Intrapartum Assessment

    Fetal head position will be determined by transabdominal ultrasonography and classified as occiput anterior, occiput transverse, or occiput posterior. The number and percentage of participants in each fetal head position category will be reported.

    Measured: Immediately before birth or when a decision for operative delivery is made.

  7. Presence of Caput Succedaneum

    The presence or absence of caput succedaneum will be assessed by intrapartum ultrasonography. The outcome will be reported as the number and percentage of participants with caput succedaneum at the final intrapartum assessment.

    Measured: Immediately before birth or when a decision for operative delivery is made.

  8. Presence of Fetal Head Molding

    The presence or absence of fetal head molding will be assessed during the final intrapartum ultrasonographic examination. The outcome will be reported as the number and percentage of participants with molding.

    Measured: Immediately before birth or when a decision for operative delivery is made.

  9. Duration of the Active Second Stage of Labor

    The duration of the active second stage will be calculated in minutes from the beginning of active maternal pushing to birth of the neonate.

    Measured: From initiation of active pushing to birth.

  10. Total Duration of the Second Stage of Labor

    The total duration of the second stage will be calculated in minutes from confirmation of full cervical dilatation to birth of the neonate.

    Measured: From full cervical dilatation to birth.

  11. Mode of Delivery

    Mode of delivery will be classified as spontaneous vaginal delivery, operative vaginal delivery, or cesarean delivery. The number and percentage of participants in each category will be reported.

    Measured: At delivery.

  12. Episiotomy

    The number and percentage of participants undergoing episiotomy will be recorded from the delivery record.

    Measured: At delivery.

  13. Degree of Perineal Laceration

    Perineal trauma will be classified as no laceration or first-, second-, third-, or fourth-degree perineal laceration according to the clinical assessment performed after delivery. The number and percentage of participants in each category will be reported.

    Measured: Immediately after delivery.

  14. Postpartum Blood Loss

    Postpartum blood loss will be recorded in milliliters. The same predefined method of blood loss assessment will be applied to participants in both study groups.

    Measured: From birth through the first 24 hours postpartum.

  15. Maternal Childbirth Experience Assessed Using the Childbirth Experience Questionnaire

    Maternal childbirth experience will be assessed using the validated Turkish version of the Childbirth Experience Questionnaire (CEQ). The overall CEQ score and the scores for the Own Capacity, Professional Support, Perceived Safety, and Participation domains will be calculated. Higher scores indicate a more positive childbirth experience.

    Measured: Within the first 24 hours after birth.

  16. Apgar Score at 1 Minute

    The neonatal Apgar score will be assessed 1 minute after birth. The total score ranges from 0 to 10, with higher scores indicating better neonatal condition.

    Measured: At 1 minute after birth.

  17. Apgar Score at 5 Minutes

    The neonatal Apgar score will be assessed 5 minutes after birth. The total score ranges from 0 to 10, with higher scores indicating better neonatal condition.

    Measured: At 5 minutes after birth.

Timeline

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

  1. First posted14 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

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
Parallel groups
Model description
This is a randomized, controlled, parallel-group clinical trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07874243
Sponsor's protocol ID
E-10840098-50.04-5456
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The investigators have not yet made a final decision regarding the sharing of de-identified individual participant data. The decision will be made after study completion, taking into consideration participant consent and institutional policies.

Publications

  • Youssef A, Maroni E, Ragusa A, De Musso F, Salsi G, Iammarino MT, Paccapelo A, Rizzo N, Pilu G, Ghi T. Fetal head-symphysis distance: a simple and reliable ultrasound index of fetal head station in labor. Ultrasound Obstet Gynecol. 2013 Apr;41(4):419-24. doi: 10.1002/uog.12335. Epub 2013 Mar 6.

    PubMed 23124698
  • Dencker A, Bergqvist L, Berg M, Greenbrook JTV, Nilsson C, Lundgren I. Measuring women's experiences of decision-making and aspects of midwifery support: a confirmatory factor analysis of the revised Childbirth Experience Questionnaire. BMC Pregnancy Childbirth. 2020 Apr 6;20(1):199. doi: 10.1186/s12884-020-02869-0.

    PubMed 32252679
  • Van Adrichem A, Faes E, Kinget K, Jacquemyn Y. Intrapartum ultrasound: viewpoint of midwives and parturient women and reproducibility. Int J Womens Health. 2018 Jun 6;10:251-256. doi: 10.2147/IJWH.S155865. eCollection 2018.

    PubMed 29922095

Questions about this trial

What is this clinical trial studying?

A study testing Using a vertical birthing chair during the active second stage of labor in people with Labor and Delivery, run by Kartal City Hospital 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 9 inclusion and 10 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 14 Oct 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 Elif Unlugedik Sayin, MD, PhD (+905322348083, elif.unlugedik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. Change in Angle of Progression From Baseline to 30 Minutes (time frame: From baseline at full cervical dilatation to 30 minutes after initiation of the assigned maternal position.). 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 NCT07874243, which also lists 3 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 14 Oct 2026.

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