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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05955352
• Other study ID #: TribhuvaU
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: Tribhuvan University, Nepal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

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Related Conditions & MeSH terms

• Heat Therapy
• Labor
• Pain
• Perineal Tear

Intervention

Procedure:
• Perineal warm compression Technique
There will be two groups. Interventional group will receive perineal warm compression and control group will receive standard care to asses the pain intensity and perineal tear

Locations

Country	Name	City	State
Nepal	Tribhuvan University Teaching Hospital	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of pain intensity	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.	15 minutes after application of warm compression
Primary	Perineal outcomes	Perineal outcomes will be assessed as the degree of tears during childbirth as an effect of perineal warm compression	1 hour after application of warm compression