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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05851170
Enrollment
412
Registered
2023-05-09
Start date
2023-06-11
Completion date
2024-06-01
Last updated
2023-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perineum; Tear

Keywords

Perineal tear, Warm compresses, Intact perineum, Almond oil

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.

Interventions

OTHERThe 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.

OTHERUse 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

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with perineal tear2 yearsPerineal tear (spontaneous) that required suturing

Secondary

MeasureTime frameDescription
Number of patients with episiotomy2 yearsThe rate of episiotomy
Number of patients with mild perineal tear2 yearsFirst and second degree
Number of patients with with advanced perineal tear2 yearsThird and fourth degree

Countries

Israel

Contacts

Primary ContactRaneen Abu Shqara, MD
rabushqara@gmail.com+972549793591
Backup ContactSusana Mustafa, MD
mustafa.susana@gmail.com+972502061625

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026