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

Study Overview
=================
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.

Official Title
-----------------
Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears: a Randomized Controlled Trial

Conditions
-----------------
Perineum; Tear

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of warm compresses and almond oil use during the second stage<br>Warm compresses will be attached to the perineum between pushing During active pushing - almond oil will be used on the perineum (our routine care). | Other: The use of warm compresses and almond oil on the perineum during second stage<br>* 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.<br>* Other names: Experimental;|
| Active Comparator: Use of almond oil use (routine care) during the second stage<br>During active pushing - almond oil will be applied on the perineum | Other: Use of almond oil use (routine care) during second stage<br>* Routine care in the department is the use of almond oil during the second stage of pregnancy, during pushing.<br>* Other names: Routine care;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with perineal tear | Perineal tear (spontaneous) that required suturing | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with episiotomy | The rate of episiotomy | 2 years | 
| Number of patients with mild perineal tear | First and second degree | 2 years | 
| Number of patients with with advanced perineal tear | Third and fourth degree | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perineal tear, Warm compresses, Intact perineum, Almond oil