The effectiveness of Peanut Ball device during labor

Not Applicable

• Registration Number: CTRI/2019/08/020802
• Lead Sponsor: Indian Council of Medical Research Extramural Funding

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. effectiveness of the use of peanut ball device during labor in terms of following neonatal outcomes; <br/ ><br>-Fetal heart rate patterns <br/ ><br>-Neonatal Intensive Care Unit (NICU) admissions <br/ ><br>-APGAR score at the time of birth at one minute and five minute <br/ ><br>-Birth injuries <br/ ><br>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