An interventional study of The use of warm compresses and almond oil on the perineum during second stage and Use of almond oil use (routine care) during second stage in Perineum; Tear, sponsored by Western Galilee Hospital-Nahariya. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Western Galilee Hospital-Nahariya · Not applicable, Interventional, and Prevention
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.
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.
174 studies on the registry are indexed under Lacerations; 43 are open to participants now.
This study's planned enrollment of 412 is above the median of 65 across 128 interventional studies indexed under Lacerations.
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Exclusion Criteria:
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
During active pushing - almond oil will be applied on the perineum
Other: Use of almond oil use (routine care) 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.
Also known as: Experimental
Routine care in the department is the use of almond oil during the second stage of pregnancy, during pushing.
Also known as: Routine care
Number of patients with perineal tear
Perineal tear (spontaneous) that required suturing
Time frame: 2 years
Number of patients with episiotomy
The rate of episiotomy
Time frame: 2 years
Number of patients with mild perineal tear
First and second degree
Time frame: 2 years
Number of patients with with advanced perineal tear
Third and fourth degree
Time frame: 2 years
Plan to share: Undecided
Started Jun 2023 (actual). Primary completion is estimated for Jun 2024, 11 months after the start.
Of 46 non-industry interventional studies with no phase under Lacerations, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 72. This study's planned 11 months is below that.
Counting every sponsor, half of 50 studies reached it within 19 months; a quarter within 12 and three quarters within 72.
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This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Western Galilee Hospital-Nahariya