Topical estrogen treatment for recovery from severe postpartum injuries
Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery: a Randomized Clinical Trial
This study is testing if a vaginal estrogen cream can help women recover better from severe injuries they got during childbirth.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05317364 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of topical vaginal estrogen therapy on women who have sustained obstetric anal sphincter injuries (OASIS) during childbirth. Participants will be randomly assigned to receive either estradiol vaginal cream or a placebo starting two weeks after their hospital discharge. The study aims to assess improvements in sexual function, urinary incontinence, and overall recovery outcomes. By focusing on the role of estrogen in wound healing and tissue quality, the trial seeks to provide a potential treatment option for women experiencing significant morbidity from these injuries.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 years or older who have sustained 3rd or 4th degree lacerations during childbirth.
Not a fit: Patients with contraindications to intra-vaginal estrogen therapy, such as a history of DVT or hormone-responsive breast cancer, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes and quality of life for women suffering from complications related to OASIS.
How similar studies have performed: While there are limited studies specifically addressing OASIS treatment, previous research on topical estrogen therapy for vaginal atrophy in postmenopausal women has shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * women who sustained 3rd or 4th degree lacerations * aged 18 years or older * must be able to self apply vaginal cream Exclusion Criteria: * 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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Hannah L Chapman, MD — University of Alabama at Birmingham
- Study coordinator: Hannah L Chapman, MD
- Email: hlchapman@uabmc.edu
- Phone: 3072626398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.