Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function (NCT03493126) | Clinical Trial Compass
CompletedPhase 4
Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function
United States59 participantsStarted 2018-10-15
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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.