Last reviewed · How we verify
NCT03559816: SEPT-1
Selective Use of Episiotomy: the Impact on Perineal Trauma.
trial testing Classification of perineal tears based on new classification in Perineal Tear in 10,000 participants. Completed in 30 April 2022.
31 December 2021
Quick facts
| Lead sponsor | Universita di Verona |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10,000 |
| Start date | 1 February 2021 |
| Primary completion | 31 December 2021 |
| Estimated completion | 30 April 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Classification of perineal tears based on new classification
- Selective use of Episiotomy
Conditions studied
- Perineal Tear — all drugs for Perineal Tear →
- Episiotomy Wound — all drugs for Episiotomy Wound →
- Delivery; Injury, Maternal — all drugs for Delivery; Injury, Maternal →
Sponsor
Universita di Verona — full company profile →
Who can join
Adults 18 to 50, female only, with Perineal Tear or Episiotomy Wound. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vaginal delivery is commonly accompanied by trauma of the genital tract. Perineal trauma is classified into four degrees based on anatomic structures involved and severity of lacerations according to the American College of Obstetricians and Gynaecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG). Episiotomy is an intentional perineal incision performed by midwifes or obstetricians to enlarge vaginal opening during the second stage of childbirth and has become the most common surgical procedure worldwide. A routine use of episiotomy was proposed to prevent severe spontaneous lacerations, although it failed to to demonstrate a clear protective role with no benefits both for mother and baby. Therefore the guidelines changed in a selective use of episiotomy, and we have introduced it in our routine obstetrics care. Nevertheless, second-degree lacerations comprise a wide range of lesions, from a minimal involvement to a massive damage of the perineal muscles. Therefore, it was never confirmed that selective use of episiotomy reduce the perianal trauma in the range of second degree lesions. We designed a prospective observational study with the introduction of a new classification of perineal trauma recorded with the usual data retrieved in delivery ward register. The aim is to definitively investigate if selective use of episiotomy reduce the overall perineal trauma.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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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 NCT03559816 (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 Universita di Verona
- Last refreshed: 12 May 2022
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