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

NCT07333209 | Recruiting DMC

• 1 other identifier: MRC-01-25-1104
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor (Obstetrics)--Complications

Keywords

Peanutball; Scheduled positioning; Primiparous women; Randomized controlled trial; Non-invasive intrapartum intervention; Maternal labor outcomes; Neonatal outcomes; Epidural Analgesia

Outcome Measures

Primary Outcomes (10)

• 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).

  12hours to 16 hours

• Duration of Second Stage of Labor

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

  2 Hours to 3 Hours

• Mode of Delivery

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

  At delivery

• Use of Oxytocin Augmentation

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

  During labor

• Postpartum Hemorrhage

  Occurrence of postpartum hemorrhage defined as estimated blood loss ≥500 mL following vaginal delivery or ≥1000 mL following cesarean delivery within 24 hours postpartum.

  3 hours after delivery

• Degree of Perineal Trauma

  Perineal injury classified as first-degree, second-degree, third-degree (3A, 3B, or 3C), or fourth-degree tear at the time of delivery.

  at time of delivery

• Hospitalization Cost

  Total maternal hospitalization cost calculated from admission to discharge based on institutional billing records.

  From admission to discharge

• APGAR Score

  Newborn assessment

  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.

• NICU Admission

  Number of newborn admissions in NICU

  2 hours after delivery

• Newborn Birth Injuries

  Any type of injuries during delivery time

  2 hours from delivery

Secondary Outcomes (3)

• Education Status

  6 months

• BMI

  6 Months

• Age

  6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Peanut Ball-Assisted Scheduled Maternal Positioning

Other: Scheduled Maternal Positioning with use of peanutball

Control Arm

ACTIVE COMPARATOR

Standard Intrapartum Care

Other: Scheduled Maternal Positioning with use of peanutball

Interventions

Scheduled Maternal Positioning with use of peanutball OTHER

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.

Control Arm; Intervention Arm

Eligibility Criteria

• Age: 16 Years - 55 Years
• Gender Eligibility Details: Females are eligible, as the study involves pregnant, laboring women receiving intrapartum care and first-time full-term pregnancy .
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Women's Wellness and research center

Doha, Baladīyat ad Dawḩah, 3050, Qatar

RECRUITING

Related Publications (18)

• 36. Williams, H., Thompson, J., & Lee, A. (2018). The impact of semi-sitting position on labor progression and maternal comfort. Journal of Obstetrics and Gynecology Research, 44(6), 1123-1130.

  BACKGROUND

• Suraci N, Carr C, Peck J, Hoyos J, Rosen G. Improving labour progression among women with epidural anesthesia following use of a birthing ball: a review of recent literature. J Obstet Gynaecol. 2020 May;40(4):491-494. doi: 10.1080/01443615.2019.1633519. Epub 2019 Sep 3.

  PMID: 31476927 BACKGROUND

• Stulz V, Campbell D, Yin B, Al Omari W, Burr R, Reilly H, Lawson K. Using a peanut ball during labour versus not using a peanut ball during labour for women using an epidural: study protocol for a randomised controlled pilot study. Pilot Feasibility Stud. 2018 Oct 4;4:156. doi: 10.1186/s40814-018-0346-9. eCollection 2018.

  PMID: 30305919 BACKGROUND

• 29. SÖNMEZ, T., & Apay, S. E. (2023). Effect of Different Birth Balls Used at the First Stage of Labor on Birth Outcomes and Maternal Satisfaction: A Randomized Controlled Trial. Clinical and Experimental Health Sciences, 13(3), 600-607.

  BACKGROUND

• Salameh KM, Anvar Paraparambil V, Sarfrazul A, Lina Hussain H, Sajid Thyvilayil S, Samer Mahmoud A. Effects of Labor Epidural Analgesia on Short Term Neonatal Morbidity. Int J Womens Health. 2020 Feb 4;12:59-70. doi: 10.2147/IJWH.S228738. eCollection 2020.

  PMID: 32099485 BACKGROUND

• 25. Prasad, I. R., & Awasthi, P. (2023). Effectiveness of Squatting Position on the Duration of Labor and Maternal Satisfaction among primigravida Mothers: A Mixed Method Approach. International Journal of Nursing Research, 57-62.

  BACKGROUND

• Kamath P, Pai M, Shenoy R, Karkada S, D'souza S, Noronha J. Effectiveness of a peanut ball device during labour on maternal and neonatal outcomes: protocol for a randomised controlled trial. F1000Res. 2022 Jun 29;11:717. doi: 10.12688/f1000research.109537.2. eCollection 2022.

  PMID: 36531256 BACKGROUND

• Alan Dikmen H, Gonenc IM, Atas AN. Effects of peanut ball use on perceived labor pain, fatigue, and mother's perception of childbirth: a randomized controlled trial. Arch Gynecol Obstet. 2025 Jun;311(6):1579-1589. doi: 10.1007/s00404-024-07656-2. Epub 2024 Aug 5.

  PMID: 39103620 BACKGROUND

• 14. Delgado, A. M., da Silva, R. D. C. B., Medeiros, P. J. A., de Souza Melo, R., & de Oliveira, A. L. B. (2022). Peanut ball used for reducing maternal fatigue during labor: protocol for a randomized clinical trial. Research, Society and Development, 11(11),

  BACKGROUND

• de Verastegui-Martin M, de Paz-Fresneda A, Jimenez-Barbero JA, Jimenez-Ruiz I, Ballesteros Meseguer C. Influence of Laboring People's Mobility and Positional Changes on Birth Outcomes in Low-Dose Epidural Analgesia Labor: A Systematic Review with Meta-Analysis. J Midwifery Womens Health. 2023 Jan;68(1):84-98. doi: 10.1111/jmwh.13446. Epub 2022 Dec 12.

  PMID: 36504479 BACKGROUND

• Delgado A, Katz L, Melo RS, Amorim M, Lemos A. Effectiveness of the peanut ball use for women with epidural analgesia in labour: a systematic review and meta-analysis. J Obstet Gynaecol. 2022 Jul;42(5):726-733. doi: 10.1080/01443615.2021.1997959. Epub 2022 Jan 7.

  PMID: 34996318 BACKGROUND

• Macena de Almeida ME, Mendes SS, Maria de Vasconcelos Oliveira N, Vasconcelos Neto JA, Lopes LG, Moreira Vasconcelos CT. Peanut Ball Utilization Protocols in Women During Labour and Delivery: An Integrative Review. J Obstet Gynaecol Can. 2023 Nov;45(11):102185. doi: 10.1016/j.jogc.2023.07.005. Epub 2023 Jul 19.

  PMID: 37473916 BACKGROUND

• Callahan EC, Lee W, Aleshi P, George RB. Modern labor epidural analgesia: implications for labor outcomes and maternal-fetal health. Am J Obstet Gynecol. 2023 May;228(5S):S1260-S1269. doi: 10.1016/j.ajog.2022.06.017. Epub 2023 Mar 20.

  PMID: 37164496 BACKGROUND

• 6. Brown, T., Miller, S., & Davis, K. (2017). Effects of alternating lateral positions on maternal circulation and fetal well-being during labor. Journal of Maternal-Fetal Medicine, 22(4), 210-217

  BACKGROUND

• 5. Box, M. M. (2023). Implementation and Evaluation of a Peanut Ball Protocol in Laboring Mothers After Epidural Placement (Doctoral dissertation, Southeastern Louisiana University).

  BACKGROUND

• 3. Ahmed, A. H., Mohmed, A. A., & Fathalla, N. F. (2022). Effect of Peanut Birth Ball on The Progress of Labor and Birth Outcome among Primigravidae. Alexandria Scientific Nursing Journal, 24(4), 91-101.

  BACKGROUND

• 2. Ahmadpour, A., Bakhshi, S., & Haghani, H. (2020). Use of the peanut ball during labour: A systematic review and meta-analysis. Journal of Clinical Nursing, 29(19-20), 3679-3691. https://doi.org/10.1111/jocn.15338

  BACKGROUND

• 1. Abdelhady, I. S., Salama, E. I., Ahmed, S. N., Masry, A., & Gad, A. (2023). The Effect of Epidural Analgesia on Maternal and Early Neonatal Outcomes: A Retrospective Cohort Study in Qatar. Journal of Pediatrics, Perinatology and Child Health, 7(1), 55-61.

  BACKGROUND

Study Officials

• Parveen Nather

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Parveen N Nather, Master's in nursing

CONTACT

00974-77641213; pnather@hamad.qa

Dr.Ananth Nazarene, PHD in Nursing

CONTACT

00974-50827647; pnather@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study uses a parallel-group randomized controlled trial design in which primigravida women receiving epidural analgesia are 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 the peanut ball. Outcomes for both groups will be compared prospectively to determine the effect of the intervention on labor progression and maternal and neonatal outcomes.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)