Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears
Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears: a Randomized Controlled Trial
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Raneen Abu Shqara, MD
- Phone Number: +972549793591
- Email: rabushqara@gmail.com
Study Contact Backup
- Name: Susana Mustafa, MD
- Phone Number: +972502061625
- Email: mustafa.susana@gmail.com
Study Locations
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Hazafon
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Nahariya, Hazafon, Israel
- Recruiting
- Galilee Medical Center
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Contact:
- Amal Shahen
- Email: amals@gmc.gov.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- 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
Warm compresses will be attached to the perineum between pushing During active pushing - almond oil will be used on the perineum (our routine care).
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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 Names:
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Active Comparator: Use of almond oil use (routine care) during the second stage
During active pushing - almond oil will be applied on the perineum
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Routine care in the department is the use of almond oil during the second stage of pregnancy, during pushing.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with perineal tear
Time Frame: 2 years
|
Perineal tear (spontaneous) that required suturing
|
2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients with episiotomy
Time Frame: 2 years
|
The rate of episiotomy
|
2 years
|
|
Number of patients with mild perineal tear
Time Frame: 2 years
|
First and second degree
|
2 years
|
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Number of patients with with advanced perineal tear
Time Frame: 2 years
|
Third and fourth degree
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Raneen Abu Shqara, MD, Galilee Medical Center
Publications and helpful links
General Publications
- Geranmayeh M, Rezaei Habibabadi Z, Fallahkish B, Farahani MA, Khakbazan Z, Mehran A. Reducing perineal trauma through perineal massage with vaseline in second stage of labor. Arch Gynecol Obstet. 2012 Jan;285(1):77-81. doi: 10.1007/s00404-011-1919-5. Epub 2011 May 26.
- Aasheim V, Nilsen ABV, Reinar LM, Lukasse M. Perineal techniques during the second stage of labour for reducing perineal trauma. Cochrane Database Syst Rev. 2017 Jun 13;6(6):CD006672. doi: 10.1002/14651858.CD006672.pub3.
- Magoga G, Saccone G, Al-Kouatly HB, Dahlen G H, Thornton C, Akbarzadeh M, Ozcan T, Berghella V. Warm perineal compresses during the second stage of labor for reducing perineal trauma: A meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2019 Sep;240:93-98. doi: 10.1016/j.ejogrb.2019.06.011. Epub 2019 Jun 15.
- Pierce-Williams RAM, Saccone G, Berghella V. Hands-on versus hands-off techniques for the prevention of perineal trauma during vaginal delivery: a systematic review and meta-analysis of randomized controlled trials. J Matern Fetal Neonatal Med. 2021 Mar;34(6):993-1001. doi: 10.1080/14767058.2019.1619686. Epub 2019 Jun 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NHR-0198-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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