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).
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
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
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- 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
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- 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.
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
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.
- Conditions
- Labor and Delivery
- 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 group | Role | What they receive |
|---|---|---|
| Intervention arm- Vertical Birth Chair group | Active comparator | Participants 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 Group | No intervention | Participants 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. 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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Episiotomy
The number and percentage of participants undergoing episiotomy will be recorded from the delivery record.
Measured: At delivery.
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.
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.
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.
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.
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.
- First posted14 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Labor and DeliveryStudies of the same condition, open and under way.
- 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
- This is a randomized, controlled, parallel-group clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kartal City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Unlugedik Sayin, Kartal City Hospital
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 23124698Dencker 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 32252679Van 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