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Conservative Treatment or Resuturing Among Women With Perineal Wound Dehiscence After Vaginal Labour

Study acronym: HEAL
StatusCompleted
PhaseNot specified
Started
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Record History

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  1. Primary completion date changed from estimate of Sep 1, 2024 to Aug 20, 2026 Show 5 more changesShow less
    • Trial status changed: Unknown → Completed
    • Enrollment target: estimated 300 to confirmed 302
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 7 of 14 entries
    • Site details revised
  2. Changed Registry marked status Unknown; last known: Recruiting
  3. Trial status: Not Yet Recruiting to Unknown
    • Site details revised
    v3
  4. Site contact updated
    • Study description expanded, about 2 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to make us more aware of the short and long-term outcomes for women having an uncomplicated healing process after a rupture or birth cut in the perineum after giving birth in relation to a healing process with a dehisced wound treated with conservative management or secondary suturing. Participants will be asked to do * A gynecological examination at one month after birth and 9-12 months after birth. * Have a picture taken of the healing process * Answer a questionnaire at one month, three months, and 9-12 months after birth
Trial Details
NCT Number NCT06026423
Lead Sponsor Herlev Hospital
Conditions
(from sponsor)		 Dehiscence Wound, Secondary Perineal Tear, Episiotomy; Dehiscence
Enrollment 302 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov