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RECRUITING

NCT07333209

Scheduled Positioning With a Peanutball(SPP) on Labor Outcomes Among Primiparous Women Under Epidural Analgesia

Sponsor: Hamad Medical Corporation

View on ClinicalTrials.gov

Summary

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.

Official title: Determine the Impact of Scheduled Positioning With a Peanutball on Labor Outcomes Among Primiparous Women Under Epidural Analgesia: A Non-Invasive Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

16 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2026-01-01

Completion Date

2026-06-30

Last Updated

2026-01-12

Healthy Volunteers

Conditions

Labor (Obstetrics)--Complications

Interventions

OTHER

Scheduled Maternal Positioning with use of peanutball

Participants will receive standard intrapartum care following epidural analgesia plus scheduled maternal position changes using a peanut birthing ball. The peanut ball will be placed between the participant's legs, and maternal positions will be changed at predefined intervals according to the study protocol. Positions include left lateral, right lateral, semi-sitting, and Taylor positions. All positioning will be supervised by trained nursing and midwifery staff and adjusted as needed based on maternal comfort and fetal heart rate monitoring.

Inclusion Criteria: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. Exclusion Criteria:The birthing ball should NOT be used in any of the following conditions: 1. 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 2. 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 3. 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 4. 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 5. 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

Locations (1)

Women's Wellness and research center

Doha, Baladīyat ad Dawḩah, Qatar