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Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears

NCT05851170 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2023-06-29

No results posted yet for this study

Summary

There is a controversy regarding whether warm compresses influence the rate of intact perineum after a vaginal delivery.

According to a meta-analysis published in 2019 that included 7 randomized prospective trials, approximately 2103 participants, the use of warm compresses during the second stage of labor increased the chance of an intact perineum RR=1.46, decreased the chance of a third degree tear RR=0.38 and grade four tear RR=0.11. The limitations noted in this meta-analysis include non-uniformity in the methods of the studies included in the meta-analysis in terms of the number of participants, the duration of use of the compresses, and the temperature of the compresses. In summary, it is reported that there is a need for more randomized studies.

Since there is a need for more randomized studies in the field, the study's goal is to conduct a randomized study that will compare the use of warm compresses in the second stage of labor against a standard care control group (almond oil) - in terms of perineal tear that will require suturing.

Conditions

  • Perineum; Tear

Interventions

OTHER

The use of warm compresses and almond oil on the perineum during second stage

Hot water from the tap at a temperature of (45-590c) will be poured into a container, and will be changed every 15 minutes. Timing of the start: when the baby's head descends in the pelvic canal and the woman feels the need to push The intervention: warm compresses will be attached to the perineum between the pressures During the pressing - almond oil will be applied. Meanwhile, the compresses will be returned to a bowl containing hot water. Every 15 minutes until birth the water will be replaced with hot water at an initial temperature of 45-590c. It is necessary to use compresses for a minimum of 10 minutes, and a maximum of 30 minutes.

OTHER

Use of almond oil use (routine care) during second stage

Routine care in the department is the use of almond oil during the second stage of pregnancy, during pushing.

Sponsors & Collaborators

  • Western Galilee Hospital-Nahariya

    lead OTHER_GOV

Principal Investigators

  • Raneen Abu Shqara, MD · Galilee Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-11
Primary Completion
2024-06-01
Completion
2024-06-01

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851170 on ClinicalTrials.gov