The Effect of Using Perineal Warm Compress Techniques During the Second Stage of Labor on Perineal Outcomes

Not Applicable

Completed

• Conditions: Perineal Tear; Heat Therapy; Pain; Labor

• Registration Number: NCT05955352
• Lead Sponsor: Tribhuvan University, Nepal

Brief Summary

The goal of the clinical trial is to determine the effect of second-stage warm compress application on perineal pain and trauma among primiparous women. The main questions may reveal the pain intensity and the perineal outcome of the warm compress which might be helpful to the women during labor and related authority of the hospital.

The intervention with warm perineal compression will be done among primiparous mothes during second stage of labor

Detailed Description

Participants

* After full dilatation of the cervix, assign participants in a 1:1 ratio to the study and control groups randomly.

* Ask women to select one closed envelope containing a card with the group allocation (study or control groups)

* Provide usual care according to the unit protocol to all the women until the second stage of labor.

* Provide the participants of the study group with a warm perineal compress during the whole second stage of labor

* Provide usual care according to the unit protocol to the participants of control group during the whole second stage of labor.

The process of applying the warm perineal compress

* Fill a clean container with warm water (45-59°C)

* Soak a clean pad in the water, squeeze then place gently on the perineum during each uterine contraction.

* Maintain the temperature between 38-44°C during its application.

* Re-soak the pad in warm water between contractions, to maintain warmth and then reapply.

* Replace the water in the container every 15 minutes until delivery or if the temperature drop below 45°C

Study Timeline

• Study Start: 2023-02-20
• Primary Completion: 2023-05-30
• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-21
• Study Completion: 2023-09-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-14
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

Low-risk pregnant mothers such as no hypertension, Headache, Bleeding Infection etc -

Exclusion Criteria

Pregnancy with any health problems such as Preeclampsia, Bleeding, Obstructed Labour, Cesarean section

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
level of pain intensity	15 minutes after application of warm compression	Pain intensity will be assessed using an NPRS after the application of warm compression on perineum during the second stage of labor and The scale ranges from 0 to 10, where 0 indicates no pain, and 10 represents the worst level of pain. In between these two extremes, words such as mild, moderate, severe, and very severe pain are assigned to each 2 cm distance on the line, respectively.
Perineal outcomes	1 hour after application of warm compression	Perineal outcomes will be assessed as the degree of tears during childbirth as an effect of perineal warm compression

Trial Locations

Locations (1)

Tribhuvan University Teaching Hospital; 🇳🇵 Kathmandu, Bagmati, Nepal