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

Not Applicable

Recruiting

• Conditions: Perineum; Tear
• Interventions: Other: The use of warm compresses and almond oil on the perineum during second stage; Other: Use of almond oil use (routine care) during second stage

• Registration Number: NCT05851170
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief 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.

Detailed Description

Various techniques have been developed to prevent the development of perineal tears. As reported in the literature, active protection of the perineum during the second stage of labor can reduce the rate of tears. These include massage of the perineum, hands-on technique, use of gel, and warm compresses.

According to a Cochrane review that examined the use of warm compresses published in 2017, there is no difference in terms of the rate of events of an intact perineum, perineal trauma that requires suturing, but in a subanalysis it showed that there is a decrease in the rate of advanced tears, involving the anal sphincter and the rectal mucosa (grade three and four).

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.

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-09
• Status Verified: 2023-06
• Study Start: 2023-06-11
• Last Update Submitted: 2023-06-27
• Last Update Posted: 2023-06-29
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 412

Inclusion Criteria

• Term pregnancy
• Singleton pregnancy
• Vertex presentation

Exclusion Criteria

• Women with a history of third degree perineal tear in the past
• Intrauterine fetal death
• Crohn disease with perineal involvement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use of warm compresses and almond oil use during the second stage	The use of warm compresses and almond oil on the perineum during second stage	Warm compresses will be attached to the perineum between pushing During active pushing - almond oil will be used on the perineum (our routine care).
Use of almond oil use (routine care) during the second stage	Use of almond oil use (routine care) during second stage	During active pushing - almond oil will be applied on the perineum

Primary Outcome Measures

Name	Time	Method
Number of patients with perineal tear	2 years	Perineal tear (spontaneous) that required suturing

Secondary Outcome Measures

Name	Time	Method
Number of patients with mild perineal tear	2 years	First and second degree
Number of patients with with advanced perineal tear	2 years	Third and fourth degree
Number of patients with episiotomy	2 years	The rate of episiotomy

Trial Locations

Locations (1)

Galilee Medical Center; 🇮🇱 Nahariya, Hazafon, Israel