Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears
NCT ID: NCT05851170
Last Updated: 2023-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
412 participants
INTERVENTIONAL
2023-06-11
2024-06-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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).
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.
Use of almond oil use (routine care) during the second stage
During active pushing - almond oil will be applied on the perineum
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton pregnancy
* Vertex presentation
Exclusion Criteria
* Intrauterine fetal death
* Crohn disease with perineal involvement
18 Years
50 Years
FEMALE
Yes
Sponsors
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Western Galilee Hospital-Nahariya
OTHER_GOV
Responsible Party
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Dr Raneen Abu Shqara
Principal investigator, clinical instructor
Principal Investigators
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Raneen Abu Shqara, MD
Role: PRINCIPAL_INVESTIGATOR
Galilee Medical Center
Locations
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Galilee Medical Center
Nahariya, Northern District, Israel
Countries
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Central Contacts
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Facility Contacts
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Amal Shahen
Role: primary
References
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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.
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.
Other Identifiers
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NHR-0198-22
Identifier Type: -
Identifier Source: org_study_id