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- Ensayo clínico NCT07918872
Effect of Squatting Position in the Second Stage of Labor on Birth Outcomes
Effect of Squatting Position on Birth Outcomes in the Second Stage of Labor in Nulliparous Women: A Randomized Controlled Trial/ Nullipar Kadınlarda Doğumun İkinci Evresinde Çömelme Pozisyonu Uygulamasının Doğum Sonuçlarına Etkisi: Randomize Kontrollü Çalışma
The second stage of labor is a crucial phase during which the fetus progresses through the birth canal, a process significantly influenced by maternal positions. While adopting specific birthing positions during the second stage offers potential benefits for maternal and neonatal health, inappropriate positions can lead to negative short- and long-term consequences. These include severe perineal lacerations, postpartum hemorrhage, an increased risk of neonatal complications, and postpartum urinary incontinence.
Birthing positions are considered non-medical interventions because they alter physiological and anatomical adaptations during labor. These adaptations, related to pelvic dimensions, intrauterine pressure, and the progression of the fetal head through the birth canal, directly influence maternal and fetal outcomes. Studies have reported that horizontal positioning during labor increases the likelihood of cesarean delivery, assisted vaginal delivery, episiotomy, and abnormal fetal heart rates.
Conversely, upright positions offer several advantages during labor. They facilitate fetal descent by utilizing gravity, strengthen uterine contractions, reduce the risk of aortocaval compression, increase pelvic dimensions, and help maintain fetal flexion in the narrowest parts of the birth canal. In the squatting position, maternal hip flexion significantly alters the pelvic axis angles through which the fetal head progresses, facilitating spontaneous vaginal delivery. Furthermore, uterine contractions are stronger and more effective in achieving effacement and dilation in the squatting position, thereby significantly contributing to the progression of labor.
The World Health Organization (2018) Intrapartum Care Management Guidelines recommend supporting upright positions in the second stage of labor for a more positive birth experience. However, data remains limited regarding the optimal upright position for women during this stage. Accordingly, this randomized controlled experimental study was designed to examine the effects of the squatting position during the second stage of labor on obstetric, maternal, and neonatal outcomes in nulliparous women with low-risk pregnancies planning a vaginal delivery.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
It has been reported that upright positions during the second stage of labor are more beneficial than horizontal positions in improving maternal and neonatal birth outcomes and reducing certain obstetric complications. Upright positions are those in which the woman's third and fifth lumbar vertebrae are aligned vertically rather than horizontally, a practice recommended by numerous international organizations.
Upright and horizontal positions are defined based on the angle formed between the horizontal plane and the line connecting the midpoints of the maternal third and fifth lumbar vertebrae. Accordingly, an upright position is defined when the spine is vertical and this angle exceeds 45°, whereas an angle of less than 45° is considered horizontal. Despite the proven advantages of upright birthing positions during the second stage of labor, the majority of women today still commonly give birth in the supine lithotomy position. The lithotomy position is considered a risk factor for a prolonged second stage of labor due to its negative impact on uterine function and its limitation of the effects of gravity. A prolonged second stage is significantly associated with adverse maternal and neonatal outcomes, such as postpartum hemorrhage, assisted delivery, cesarean section, third- and fourth-degree perineal lacerations, and low Apgar scores. These negative outcomes can lead women to perceive their birthing experience negatively, making them more likely to develop birth anxiety in future pregnancies, prefer cesarean delivery, or avoid future childbirth altogether.
Although evidence definitively evaluating the absolute benefits and risks of various upright positions remains limited, studies suggest that positions that do not restrict sacral flexibility during labor have the potential to support superior maternal and neonatal outcomes. Upright positions that maintain sacral flexibility are considered more favorable for promoting natural childbirth because they allow for pelvic outlet expansion. Based on this literature, an ideal birthing position should positively contribute to delivery outcomes by preserving sacral flexibility, allowing full mobility of the bony pelvis to expand pelvic dimensions, and maximizing the utilization of gravity. Accordingly, the squatting position, which falls into both the upright and flexible sacrum categories, may uniquely contribute to improving outcomes in spontaneous vaginal deliveries. However, further structured research is emphasized to better define and comprehensively evaluate the specific clinical effects of the squatting position during delivery.
Hip flexion during squatting significantly alters the pelvic axis, cervical, and pelvic floor angles along which the fetal head progresses. This mechanical advantage creates additional space for the fetal rotations required during descent through the birth canal. Furthermore, it allows the fetus to benefit maximally from gravity, facilitating a faster and smoother descent while stretching the perineum gradually. By relaxing the woman's diaphragm and chest cavity, the squatting position also optimizes respiration and generates better intra-abdominal pressure. This enables more effective use of maternal abdominal muscles with less physical effort, thereby contributing to improved delivery outcomes, fewer medical interventions, and a reduced rate of intrapartum emergency cesarean sections.
In Turkey, the Ministry of Health actively promotes the expansion of "Mother-Friendly Hospital" practices. However, although the modern birthing beds used in single-patient delivery rooms within these frameworks offer women the opportunity to assume diverse positions, standard deliveries routinely continue to be performed in the conventional lithotomy position, mirroring the limitations of previously used gynecological exam tables. Consequently, research on the effects of the squatting position on the anatomy and physiology of labor, and how it alters intrapartum dynamics, is critical for guiding clinical practices in childbirth. Therefore, this study, entitled "The Effect of Squatting Position Application in the Second Stage of Labor on Birth Outcomes in Nulliparous Women: A Randomized Controlled Trial," aims to examine the effects of the squatting position during the second stage of labor in nulliparous women with low-risk pregnancies, comparing it to the widely used lithotomy position on modern birthing beds in Mother-Friendly Hospitals, on obstetric, maternal, and fetal-neonatal delivery outcomes.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Meryem Ozdemir, PhD Candidate
- Número de teléfono: +905451787789
- Correo electrónico: meryem.4214@gmail.com
Ubicaciones de estudio
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İzmir
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Izmir, İzmir, Turquía (Türkiye)
- Reclutamiento
- Cigli Training and Research Hospital
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Contacto:
- Meryem Ozdemir
- Número de teléfono: +905451787789
- Correo electrónico: meryem.4214@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Pregnant women who have read, understood, and voluntarily accepted the informed consent form both verbally and in writing,
- Individuals aged 18 years and older,
- Nulliparous pregnant women who will give birth for the first time,
- Gestational age between 37+0 and 41+6 weeks,
- Having a singleton, live fetus in vertex presentation,
- Pregnant women with intact membranes upon hospital admission (no observed amniotic fluid leakage).
Exclusion Criteria:
- Having a diagnosis of high-risk pregnancy either previously or during hospital admission for normal delivery,
- Having a body mass index (BMI) of 30 kg/m² or above,
- Having a fetus with a detected congenital anomaly,
- Having any chronic disease (such as hypertension or diabetes),
- Having a mental or cognitive illness,
- Having any type of disability (such as orthopedic, hearing, visual, or speech impairment),
- Detection of pelvic contraction findings during the vaginal examination upon admission (such as reaching the promontory or palpating the ischial spines during vaginal examination),
- Estimated fetal weight of 4000 grams or above based on ultrasonography measurements,
- Estimated fetal weight of 2500 grams or below based on ultrasonography measurements,
- Term infants diagnosed with intrauterine growth restriction (IUGR)
- Unfollowed pregnancies without routine ultrasonography measurements and screening tests.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Routine Care
For this group, following the hospital's routine clinical practices and standard intrapartum care, the upper section (head section) of the birthing bed is elevated to an angle of less than 45 degrees during delivery. The pregnant woman is placed in the lithotomy position by positioning her legs on the foot supports attached to the right and left sides of the birthing bed. The deliveries of the pregnant women included in this control group will be conducted in the lithotomy position by the researcher. |
Nulliparous pregnant women included in this control group will receive routine clinical care, and no experimental intervention will be performed until the crowning stage (when the fetal scalp becomes visible at the perineum). For this group, following standard intrapartum protocols, the upper section (head section) of the birthing bed is elevated to an angle of less than 45 degrees during delivery. The pregnant woman is placed in the conventional lithotomy position by positioning her legs on the foot supports attached to the right and left sides of the birthing bed. The deliveries of the pregnant women included in this control group will be conducted in the lithotomy position by the researcher, Expert Midwife Meryem Ozdemir.
Otros nombres:
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Experimental: Squatting Position
After the fetal head crowns from the perineum, the upper section (head section) of the birthing bed will be elevated to an angle between 45 and 60 degrees. The pregnant woman will lean against the backrest of the birthing bed and position her buttocks on the seating area. She will be assisted to place her legs in flexion at the knees, with the soles of her feet pressing firmly onto the edges of the seating area. While the pregnant woman is maintained in this position, the delivery of the fetus will be conducted by the researcher. |
Until the second stage of labor (until cervical dilation reaches 10 cm), routine clinical care will continue to be provided. During the second stage of labor, in the active phase when the pregnant woman begins to feel spontaneous urges to push, she will be supported to assume a squatting position on the birthing bed. The woman will adopt the squatting position during uterine contractions and will be allowed to rest in any position she desires on the bed between contractions. Delivery Phase: After the fetal head crowns, the upper section (head section) of the birthing bed will be elevated to an angle between 45 and 60 degrees. The pregnant woman will lean against the backrest, position her buttocks on the seating area, and place her legs in flexion at the knees, pressing her feet onto the edges of the bed. While the pregnant woman is held in this position, the delivery of the fetus will be performed by Meryem Özdemir, a specialist midwife who is part of the research team.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Duration of the second stage of labor
Periodo de tiempo: From the exact moment of full cervical dilation (10 cm) until the complete delivery of the fetus (measured in minutes)
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The time elapsed from the completion of cervical dilation (full dilation - 10 cm) to the birth of the baby will be recorded. |
From the exact moment of full cervical dilation (10 cm) until the complete delivery of the fetus (measured in minutes)
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Need for operative or obstetric interventions during delivery
Periodo de tiempo: From the onset of labor (and after the crowning of the fetal head) until the complete delivery of the infant's entire body (measured in minutes).
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The occurrence of any obstetric or operative interventions (such as episiotomy incision, vacuum extraction/Kiwi device use, or fundal pressure/Kristeller maneuver) will be recorded as a binary outcome (yes or no). |
From the onset of labor (and after the crowning of the fetal head) until the complete delivery of the infant's entire body (measured in minutes).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Perineal Laceration Degree and Episiotomy Status
Periodo de tiempo: Immediately following the delivery of the placenta.
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The severity of perineal lacerations will be evaluated based on clinical definitions: first-degree (injury to the perineal skin and/or vaginal mucosa); second-degree (injury to the perineal muscles); third-degree (injury to the anal sphincter complex and anorectal mucosa); and fourth-degree (obstetric anal sphincter injuries involving anatomical and physiological damage to the anal sphincter). If no laceration occurs, the perineum will be recorded as intact. Additionally, whether an episiotomy incision was performed by the researcher during delivery, and if so, its severity/degree will be evaluated and recorded in accordance with the clinical definitions specified above. |
Immediately following the delivery of the placenta.
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Maternal Pain Level at the Onset of the Second Stage of Labor
Periodo de tiempo: Immediately after the procedure/intervention (During the interval between uterine contractions following the onset of the second stage)
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Maternal pain levels during uterine contractions will be assessed at the exact onset of the second stage of labor (full cervical dilation) using the Visual Analog Scale (VAS), where scores range from 1 (least pain) to 10 (most severe pain). Measurements will be obtained by asking the pregnant woman during the resting period between contractions. |
Immediately after the procedure/intervention (During the interval between uterine contractions following the onset of the second stage)
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Maternal Pain Level at the Crowning Stage of the Fetal Head
Periodo de tiempo: At crowning of the fetal head, during the second stage of labor
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Maternal pain levels during uterine contractions will be assessed at the crowning stage of the fetal head using the Visual Analog Scale (VAS), where scores range from 1 (least pain) to 10 (most severe pain). Measurements will be obtained by asking the pregnant woman during the resting period between contractions. |
At crowning of the fetal head, during the second stage of labor
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Maternal Fatigue Level at the Onset of the Second Stage of Labor
Periodo de tiempo: At the onset of the second stage of labor (full cervical dilation)
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Maternal fatigue levels will be assessed at the exact onset of the second stage of labor (full cervical dilation) using the Visual Analog Scale (VAS), where scores range from 1 (least fatigue) to 10 (most severe fatigue). Measurements will be obtained by asking the pregnant woman during the resting period between contractions. |
At the onset of the second stage of labor (full cervical dilation)
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Maternal Fatigue Level at the Crowning Stage of the Fetal Head
Periodo de tiempo: At crowning of the fetal head, during the second stage of labor
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Maternal fatigue levels will be assessed at the crowning stage of the fetal head using the Visual Analog Scale (VAS), where scores range from 1 (least fatigue) to 10 (most severe fatigue). Measurements will be obtained by asking the pregnant woman during the resting period between contractions. |
At crowning of the fetal head, during the second stage of labor
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Maternal Childbirth Experience
Periodo de tiempo: Within the first 24 hours postpartum, prior to hospital discharge
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Maternal childbirth experience will be evaluated using the Childbirth Experience Questionnaire (CEQ). Participants in both the intervention and control groups will be asked to complete the questionnaire postpartum, specifically after they have breastfed their babies and achieved adequate rest, prior to hospital discharge. The total score obtained from the scale will be evaluated. Higher scores on the questionnaire indicate a more positive and better childbirth experience. There is no specific cut-off score for this scale. |
Within the first 24 hours postpartum, prior to hospital discharge
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Newborn 1st Minute APGAR Score
Periodo de tiempo: At 1 minute after birth
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The newborn's health status and transition to extrauterine life will be evaluated at the 1st minute after birth using the standard APGAR scoring system. The score ranges from 0 to 10, with higher scores indicating a better clinical condition of the newborn. |
At 1 minute after birth
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Newborn 5th Minute APGAR Score
Periodo de tiempo: At 5 minutes after birth
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The newborn's health status and adaptation to extrauterine life will be evaluated at 5 minutes after delivery using the standard APGAR scoring system. The score ranges from 0 to 10, with higher scores indicating a better clinical condition of the newborn. |
At 5 minutes after birth
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Umbilical Cord Blood Gas Parameters
Periodo de tiempo: Immediately after the delivery of the baby and prior to placental separation
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Umbilical cord blood gas analysis will be performed to evaluate the oxygenation and acid-base status of the newborn. Immediately after the complete delivery of the baby and prior to placental separation, a blood sample will be collected from the maternal side of the umbilical cord using a blood gas syringe by the researcher. The clinical parameters to be evaluated from the hospital's laboratory computer system include: umbilical artery pH, partial pressure of carbon dioxide (pCO2, measured in mmHg), partial pressure of oxygen (pO2, measured in mmHg), and base excess (BE, measured in mEq/L) |
Immediately after the delivery of the baby and prior to placental separation
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Requirement for Neonatal Resuscitation
Periodo de tiempo: During the immediate stabilization period within the first minutes after birth
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Whether the newborn requires any level of neonatal resuscitation (such as positive pressure ventilation, endotracheal intubation, or administration of medications) during the immediate stabilization period in the delivery room will be recorded as a binary outcome (yes or no). |
During the immediate stabilization period within the first minutes after birth
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Status of Being Placed in Maternal Skin-to-Skin Contact Without Intervention
Periodo de tiempo: Immediately following the delivery of the baby
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Whether the newborn can be placed directly in skin-to-skin contact with the mother or routine healthy newborn care can be provided without requiring any special medical interventions or admission to the neonatal intensive care unit (NICU) will be recorded as a binary outcome (yes or no). |
Immediately following the delivery of the baby
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Newborn Clinical Status and Physical Examination Findings
Periodo de tiempo: Within the first hour after birth
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Comprehensive newborn physical examination and clinical status findings will be evaluated and recorded by a neonatologist to ensure safety and monitor neonatal adaptation within the first hour following delivery. The evaluated parameters will include: cardiovascular findings (heart rate, preductal SpO2, and perfusion index); respiratory findings (respiratory rate, presence of chest retractions, and nasal flaring); gastrointestinal findings (presence of meconium); integumentary/skeletal findings (normal condition of the clavicle); and neurological findings (muscle tone and brachial plexus status). Any deviations from normal clinical values will be recorded. |
Within the first hour after birth
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Director de estudio: İbrahim Karaca, Prof., Çiğli Training and Research Hospital
- Silla de estudio: Esin Ceber Turfan, Prof., Ege University
Publicaciones y enlaces útiles
Publicaciones Generales
- WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/
- Gupta JK, Sood A, Hofmeyr GJ, Vogel JP. Position in the second stage of labour for women without epidural anaesthesia. Cochrane Database Syst Rev. 2017 May 25;5(5):CD002006. doi: 10.1002/14651858.CD002006.pub4.
- Fu L, Huang J, Li D, Wang H, Xing L, Wei T, Hou R, Lu H. Effects of Using Sitting Position versus Lithotomy Position during the Second Stage of Labour on Maternal and Neonatal Outcomes and the Childbirth Experience of Chinese Women: A Prospective Cohort Study. Healthcare (Basel). 2023 Nov 20;11(22):2996. doi: 10.3390/healthcare11222996.
- Desseauve D, Fradet L, Lacouture P, Pierre F. Is there an impact of feet position on squatting birth position? An innovative biomechanical pilot study. BMC Pregnancy Childbirth. 2019 Jul 19;19(1):251. doi: 10.1186/s12884-019-2408-2.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-AKD-354
- 25-AKD-354 (Otro identificador: Turkish Medicines and Medical Devices Agency)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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