Phase 4
N=59
Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
Vaginal Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT03493126 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Vulvar Assessment Scale (VUAS) — 0.10; 0.20 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Estradiol (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ohio State University
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vulvar Assessment Scale (VUAS) |
0.10; 0.20 | — |
| SECONDARY Depression |
4.07; 4.07 | — |
| SECONDARY Urinary Symptoms |
5.6; 10.5 | — |
| SECONDARY Fecal Incontinence |
16.5; 15.4 | — |
| SECONDARY Sexual Function |
25.4; 20.5 | — |
| SECONDARY Satisfaction Via Likert Scale |
14; 9; 5; 6; 8; 11 | — |
| SECONDARY Adverse Outcomes |
0; 1 | — |
Summary
Pilot randomized, placebo-controlled trial of nulliparous postpartum women with a perineal laceration following a term vaginal delivery comparing vulvovaginal atrophy symptoms between women using vaginal estrogen in the postpartum period with those using placebo.
Eligibility Criteria
Inclusion Criteria
- females >18 years old with at least one prior prenatal care appointment affiliated with The Ohio State University Wexner Medical Center; nulliparous; 1-2 days status post >37 weeks and 0 day vaginal delivery with at least a second degree perineal laceration; English-speaking and able to provide informed consent.
Exclusion Criteria
- allergies to estradiol cream or its constituents; a vaginal delivery associated with a intrauterine fetal demise or neonatal death; inability to complete questionnaires in English or comply with study protocol; and inability to apply vaginal cream independently. The following medical conditions and diagnoses are also exempted: undiagnosed abnormal vaginal bleeding, known or suspected estrogen-dependent neoplasia, active or history of deep venous thrombosis or pulmonary embolism, active arterial thromboembolic disease, known liver dysfunction or disease, known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
Data sourced from ClinicalTrials.gov (NCT03493126). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.