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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16-55
SponsorHamad Medical Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Scheduled Maternal Positioning with use of peanutball

    Other intervention

    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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Duration of First Stage of Labor

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).

Time frame
12hours to 16 hours
2

Duration of Second Stage of Labor

Time in minutes from full cervical dilation (10 cm) to delivery of the neonate.

Time frame
2 Hours to 3 Hours
3

Mode of Delivery

Categorized as spontaneous vaginal delivery, instrumental vaginal delivery (forceps or vacuum), or cesarean section.

Time frame
At delivery
4

Use of Oxytocin Augmentation

Administration of oxytocin during labor for augmentation of uterine contractions, recorded as yes or no.

Time frame
During labor

Secondary outcomes

1

Education Status

Education background of laboring women

Time frame
6 months
2

BMI

Body Mass Index

Time frame
6 Months
3

Age

Primiparous Age

Time frame
6 months

Other outcomes

Sponsors and contacts

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