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Completed

NCT Number: NCT05955352

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tribhuvan University Teaching Hospital

Kathmandu, Bagmati, 44600, Nepal

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Perineal warm compression Technique

Procedure

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

Other names: Perineal heat therapy

Primary outcomes

  1. level of pain intensity

    Time frame: 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.

  2. Perineal outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tribhuvan University, Nepal

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2023
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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