The Effect of Perineal Massage during the Second Stage of Labor on the Episiotomy Rate in Term Nulliparous Pregnant Women: A Randomized Controlled Trial

Phase 1

Completed

• Conditions: severe perineal tear; perineal massage

• Registration Number: TCTR20220820001
• Lead Sponsor: Obstetrics and Gynecology department, Khonkaen hospital

Brief Summary

The episiotomy rates were 44.8% and 89.6% in the perineal massage group and the control group, respectively. Women allocated to the perineal massage group had a lower rate of severe perineal tears (third- and fourth-degree perineal tears) than women in the control group albeit the difference was not statistically significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-20
• Study Completion: 2023-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

Thai, Nulliparous, singleton pregnant women more than 18 years old, more than 37 weeks of gestational age, with a cephalic presentation in second stage of labor who planned vaginal delivery and had good conscious and cooperative during perineal massage.

Exclusion Criteria

1.Women with pelvic and genital tract infection (e.g., intraamniotic infection, condyloma accuminata, genital herpes simplex viral infection)
2.Women with respiratory infection (e.g., Covid-19 infection, TB infection)
3.Women with preeclampsia with severe features
4.Women with history of antenatal perineal massage
5.Women with history of perineal trauma
6.Women with hypersensitivity at perineum
7.Estimated fetal weight more than 3500 grams
8.Suspected persistent fetal occiput posterior
9.Nonreassuring fetal status (i.e., inability to remove doubt in health of fetus by a particular pattern) [1]
10.Fetus with gross anomaly

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
episiotomy rate 12 months percent,episiotomy rate 12 month percent

Secondary Outcome Measures

Name	Time	Method
First and second degree perineal lacerations (%) 2.Severe perineal lacerations (third and fourth degree lacerations) (%) 12 months degree of perineal tear