Determine the Impact of Scheduled Positioning With a Peanutball on Labor Outcomes Among Primiparous Women Under Epidural Analgesia: A Non-Invasive Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Duration of First Stage of Labor
研究概览
简要总结
Brief Summary
The goal of this clinical trial is to evaluate whether scheduled maternal position changes using a peanut birthing ball improve labor outcomes in low-risk, primiparous women receiving epidural analgesia during labor. The main questions it aims to answer are:
Does scheduled maternal positioning with a peanut ball reduce the duration of the first and second stages of labor?
Does scheduled maternal positioning with a peanut ball influence mode of delivery and maternal and neonatal outcomes?
This non-invasive randomized controlled trial will be conducted at the Women's Wellness and Research Center in Qatar. Participants will be randomly assigned to either an intervention group receiving scheduled maternal position changes using a peanut birthing ball or a control group receiving standard intrapartum care without peanut ball use. Researchers will compare outcomes between the two groups to determine whether structured positioning with a peanut ball improves labor progression and delivery outcomes in women receiving epidural analgesia.
Participants in the intervention group will undergo scheduled position changes throughout labor using a peanut birthing ball, including left lateral, right lateral, semi-sitting, and Taylor positions, under the supervision of trained nursing and midwifery staff. Participants in the control group will receive routine intrapartum care following epidural analgesia without the use of a peanut ball or a structured positioning schedule.
Primary maternal outcomes include duration of the first and second stages of labor, mode of delivery, estimated blood loss, postpartum hemorrhage, use of oxytocin augmentation, degree of perineal trauma, and hospitalization cost. Neonatal outcomes include Apgar scores at 5 and 10 minutes, NICU admission, birth-related injuries, and umbilical cord blood pH. Findings from this study are expected to support evidence-based intrapartum care practices and inform clinical protocols for women receiving epidural analgesia.
详细描述
- Background and Introduction
Labor pain is recognized as one of the most intense forms of physiological pain experienced in human medicine. Although pain during childbirth is a natural and expected process, contemporary evidence-based practice supports the provision of pain relief upon maternal request, with maternal preference for analgesia considered a sufficient clinical indication. Epidural analgesia (EA) is widely regarded as the most effective pharmacological method for labor pain relief. By administering local anesthetic agents into the epidural space, EA produces a dense sensory block of the lower abdomen and lower extremities, significantly reducing or abolishing labor pain while generally preserving maternal consciousness and cooperation.
Globally, the use of epidural analgesia during labor varies but is particularly common in high-resource healthcare settings. Utilization rates range from approximately 20% to 80% of laboring women, with national estimates indicating use in around 67% of parturients in the United States, 60% in the United Kingdom, and nearly 80% in France. Despite high maternal satisfaction and effective pain control, epidural analgesia has been associated in some studies with prolonged labor, particularly during the first and second stages, and with increased rates of instrumental vaginal delivery and cesarean section. These associations remain a subject of ongoing clinical and research debate.
The World Health Organization (WHO) emphasizes maternal mobility and optimal positioning during labor as essential strategies to promote physiological birth, facilitate fetal descent, and reduce unnecessary obstetric interventions. However, in routine clinical practice, women receiving epidural analgesia frequently experience restricted mobility due to partial motor blockade, continuous fetal heart rate monitoring, and bed confinement. These factors limit the use of upright and gravity-assisted positions that may otherwise support labor progress and optimal fetal positioning. 2. Maternal Labor Positions and Peanut Ball Use
Multiple maternal positions are recommended during labor to optimize uteroplacental perfusion, encourage fetal rotation, and enhance maternal comfort. These include lateral positions, semi-sitting postures, and modified sitting positions such as the Taylor position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study is assessor-blinded. Due to the nature of the intervention (scheduled maternal positioning using a peanut ball), participants, care providers, and investigators are not masked, as the intervention is visible and requires active participation in care.
The outcomes assessor is masked to group assignment and does not participate in the delivery of the intervention. Outcome data are collected using standardized tools and extracted from medical records without indication of whether the participant received the peanut ball intervention or standard care, in order to minimize assessment bias. No other parties masked
入排标准
- 年龄范围
- 16 Years 至 55 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •To be eligible for participation, women must meet all the following criteria:
- •Primiparous (first pregnancy resulting in a live birth or stillbirth after 20 weeks of gestation).
- •Singleton at gestation.
- •Gestational age of the term (37 weeks 0 days to 41 weeks 6 days).
- •Admitted to the Labor and Delivery Unit at WWRC in active labor.
- •Received epidural analgesia for labor pain management.
- •Expected to have a vaginal delivery (e.g., no contraindications for vaginal birth identified at the time of recruitment).
- •Able to understand and communicate in Arabic or English.
- •Provide written informed consent.
排除标准
- •The birthing ball should NOT be used in any of the following conditions:
- •Obstetric Contraindications (Maternal)
- •Any situation where vaginal birth is not appropriate (e.g., absolute indication for cesarean section)
- •Non-progress of labor requiring immediate intervention
- •Severe pre-eclampsia/eclampsia
- •Active vaginal bleeding of unknown cause
- •Placenta previa (major) or vasa previa
- •Placental abruption (suspected or confirmed)
- •Preterm labor with medical contraindication to ambulation or mobility
- •Ruptured membranes with unstable fetal head (high station) → Risk of cord prolapse
- •Severe maternal exhaustion requiring bed rest
- •Maternal hemodynamic instability
- •Fetal Contraindications
- •Non-reassuring fetal heart rate requiring continuous monitoring (Category II-III tracings)
- •Malpresentation requiring immediate obstetric intervention (e.g., transverse lie)
- •Suspected macrosomia with mechanical obstruction concerns (e.g., cephalopelvic disproportion)
- •Multiple gestation with instability or complications
- •Orthopedic / Musculoskeletal Contraindications
- •Any condition that prevents safe sitting, balancing, or weight-bearing, such as: Severe hips, leg, knee, or pelvic injuries
- •Significant arthritis of the lower limbs or pelvis
- •Recent joint surgery (hip/knee replacement, pelvic repair)
- •Neuromuscular disorders affecting balance (e.g., severe neuropathy)
- •Severe sciatica limiting mobility
- •Poor trunk control or inability to maintain safe seated posture
- •High-Risk Pregnancy Conditions
- •Use of birthing balls is contraindicated if pregnancy is classified as high-risk, including Uncontrolled gestational diabetes and Uncontrolled hypertension
- •Intrauterine growth restriction with required continuous monitoring
- •Polyhydramnios or severe oligohydramnios (risk of cord compression/instability)
- •Preterm premature rupture of membranes (PPROM)
- •History of preterm birth with current instability
- •Any condition requiring bed rest or reduced mobility
- •Safety / Environmental Contraindications
- •Patients are unable to follow instructions or unsteady balance
- •No trained staff available to supervise during labor use Unstable or improperly sized birthing ball
结局指标
主要结局
Duration of First Stage of Labor
时间窗: 12hours to 16 hours
Time in minutes from onset of active labor (defined as regular uterine contractions with cervical dilation ≥4-6 cm) to full cervical dilation (10 cm).
Duration of Second Stage of Labor
时间窗: 2 Hours to 3 Hours
Time in minutes from full cervical dilation (10 cm) to delivery of the neonate.
Mode of Delivery
时间窗: At delivery
Categorized as spontaneous vaginal delivery, instrumental vaginal delivery (forceps or vacuum), or cesarean section.
Use of Oxytocin Augmentation
时间窗: During labor
Administration of oxytocin during labor for augmentation of uterine contractions, recorded as yes or no.
Postpartum Hemorrhage
时间窗: 3 hours after delivery
Occurrence of postpartum hemorrhage defined as estimated blood loss ≥500 mL following vaginal delivery or ≥1000 mL following cesarean delivery within 24 hours postpartum.
Degree of Perineal Trauma
时间窗: at time of delivery
Perineal injury classified as first-degree, second-degree, third-degree (3A, 3B, or 3C), or fourth-degree tear at the time of delivery.
Hospitalization Cost
时间窗: From admission to discharge
Total maternal hospitalization cost calculated from admission to discharge based on institutional billing records.
APGAR Score
时间窗: The Apgar Score is a standardized newborn assessment scale ranging from 0 to 10, with higher scores indicating better neonatal status, assessed at 5 and 10 minutes after delivery.
Newborn assessment
NICU Admission
时间窗: 2 hours after delivery
Number of newborn admissions in NICU
Newborn Birth Injuries
时间窗: 2 hours from delivery
Any type of injuries during delivery time
次要结局
- Education Status(6 months)
- BMI(6 Months)
- Age(6 months)
研究者
Ms. Parveen Nather
Principal Investigator
Hamad Medical Corporation