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Search / Trial NCT05317364

Topical Vaginal Estrogen for Postpartum Obstetric Anal Sphincter Injury Recovery

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Mar 30, 2022

Trial Information

Current as of July 10, 2025

Recruiting

Keywords

Obstetric Anal Sphincter Injury Sexual Dysfunction Anal Incontinence Urinary Incontinence

ClinConnect Summary

This clinical trial is studying whether using a special vaginal cream containing estrogen can help women recover better after experiencing serious tears during childbirth, known as obstetric anal sphincter injuries (OASIS). These injuries can lead to problems like sexual dysfunction and difficulties with urinary and bowel control. The trial aims to see if this estrogen treatment improves sexual health and reduces distress from these issues in postpartum women.

To participate, women must be at least 18 years old and have sustained a third or fourth degree tear during delivery. They should be able to apply the cream themselves. However, women with certain health conditions, like a history of blood clots or specific cancers, or those who smoke, cannot join. Participants will receive either the estrogen cream or a placebo (an inactive version) two weeks after giving birth and will complete questionnaires about their sexual function and any incontinence symptoms over the next six months. This study could provide valuable insights into improving recovery for women facing these challenges after childbirth.

Gender

FEMALE

Eligibility 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.

About University Of Alabama At Birmingham

The University of Alabama at Birmingham (UAB) is a prominent academic institution and research hub dedicated to advancing healthcare through innovative clinical trials. Renowned for its commitment to medical discovery and education, UAB conducts cutting-edge research across a wide array of disciplines, including oncology, cardiology, neurology, and public health. With a robust infrastructure for clinical research, UAB fosters collaboration among interdisciplinary teams, leveraging state-of-the-art facilities and resources to enhance the translation of scientific findings into effective treatments and interventions. As a leader in clinical research, UAB aims to improve patient outcomes and contribute to the broader medical community through rigorous trial design and implementation.

Locations

Birmingham, Alabama, United States

Patients applied

0 patients applied

Trial Officials

Hannah L Chapman, MD

Principal Investigator

University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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