Status:
RECRUITING
Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Obstetric; Injury Pelvic Floor
Sexual Dysfunction
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
Obstetric anal sphincter injuries (OASIS) cause significant morbidity and are well known risk factors for sexual dysfunction, urinary and anal incontinence. Postpartum and breastfeeding are relative h...
Detailed Description
Obstetric anal sphincter injuries (OASIS) are known to cause significant morbidity and are known risk factors for sexual dysfunction, urinary and anal incontinence. Recent studies have reported that w...
Eligibility Criteria
Inclusion
- women who sustained 3rd or 4th degree lacerations
- aged 18 years or older
- must be able to self apply vaginal cream
Exclusion
- Contraindications to intra-vaginal estrogen therapy (spontaneous DVT, stroke, hormone responsive breast cancer)
- tobacco use
- allergy to estradiol vaginal cream 0.01% or its constitutions
- perineal wound breakdown or infection at 2-week Postpartum visit.
Key Trial Info
Start Date :
July 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05317364
Start Date
July 14 2022
End Date
July 1 2026
Last Update
January 16 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249