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NCT05851170
Use of Warm Compresses During the Second Stage and the Risk of Perineal Tears
NA trial testing The use of warm compresses and almond oil on the perineum during second stage in Perineum; Tear in 412 participants. Status unknown.
1 June 2024
Quick facts
| Lead sponsor | Western Galilee Hospital-Nahariya |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 412 |
| Start date | 11 June 2023 |
| Primary completion | 1 June 2024 |
| Estimated completion | 1 June 2024 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- The use of warm compresses and almond oil on the perineum during second stage
- Use of almond oil use (routine care) during second stage
Conditions studied
- Perineum; Tear — all drugs for Perineum; Tear →
Sponsor
Western Galilee Hospital-Nahariya
Who can join
Adults 18 to 50, female only, with Perineum; Tear. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05851170
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05851170 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Western Galilee Hospital-Nahariya
- Last refreshed: 29 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05851170.
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