Skip to content

The effectiveness of Peanut Ball device during labor

â??The effectiveness of Peanut Ball device during labor on maternal and neonatal outcome and stress level in low-risk primigravid women - A Randomized controlled trialâ??

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020802
Enrollment
778
Registered
2019-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Peanut Ball device: Peanut ball device for experimental group during active stage of labor. When women who is randomized in antenatal OPD comes to the labour ward for delivery, the low-

Sponsors

Indian Council of Medical Research Extramural Funding
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Low risk primigravid antenatal women admitted in labor theatre for labor who is 1. aged between 18 to 40 years 2. singleton pregnancy and in cephalic presentation 3. women in the active stage of labor 4. gestational age of 37.0 to 41.6 weeks 5. willing to use the peanut ball during 1st stage of labor 6. preferring a vaginal delivery

Exclusion criteria

Exclusion criteria: Women who are: 1. known to have any major fetal anomalies 2. low-risk antenatal mother with any medical problems or pregnancy-related complications during the study (major complications like eclampsia, preterm labor, placenta praevia, malpresentation) 3. high-risk mothers (with diabetes mellitus or pituitary disease, mother on steroid therapy, and pregnancy complications such as preeclampsia or gestational diabetes, abnormal fetal presentation (during the study or labor), placenta Previa) 4. contraindication for vaginal delivery 5. multigravida 6. multiple pregnancies 7. had any sort of fracture of leg/problem in past 8. not using peanut ball at least 15 minutes per hour during labor 9. having weight more than 90kg

Design outcomes

Primary

MeasureTime frame
1. effectiveness of use of peanut ball device during labor 2. Behavioural response of low risk primigravid women during active stage of labor. 3.Stress level of low-risk primigravid women. 4.Childbirth experiences of low risk primigravid women.. 5.Level of maternal satisfaction of lowrisk primigravid women after delivery.Timepoint: 36 months

Secondary

MeasureTime frame
1. effectiveness of the use of peanut ball device during labor in terms of following neonatal outcomes; -Fetal heart rate patterns -Neonatal Intensive Care Unit (NICU) admissions -APGAR score at the time of birth at one minute and five minute -Birth injuries 2. Stress level of neonates of experimental and control group as measured by salivary and umbilical plasma cortisol level at the time of birth.Timepoint: 48 months

Countries

India

Contacts

Public ContactPratibha Kamath

Kasturba Medical College Manipal, MAHE

mvpai@manipal.edu9845637928

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 17, 2026