Vaginal Estrogen on Postpartum Atrophy, Perineal Pain, and Sexual Function

The Ohio State University

Status and phase: Completed; Phase 4

Conditions: Vaginal Atrophy

Treatments: Drug: Estradiol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03493126

2018H0006

Details and patient eligibility

About

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.

Full description

The overall goal of this study is to determine whether there are benefits to use of low-dose vaginal estrogen in the postpartum period. Dyspareunia and vaginal/perineal pain are well-known sequelae after vaginal delivery. However, the contribution of postpartum vaginal atrophy to these issues is largely unknown. Although the relationship between lactation, relative estrogen deprivation, and vulvovaginal atrophy has been established, there is a paucity of data regarding on the prevalence of vulvovaginal atrophy symptoms in the postpartum period. Additionally, although the benefits of vaginal estrogen in postmenopausal atrophy are well-established, the benefits in the postpartum period are unknown.

Enrollment: 59 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 2 patient groups, including a placebo group

Estradiol

Experimental group

Description:

Estrace: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.

Treatment:

Drug: Estradiol

Placebo

Placebo Comparator group

Description:

Placebo: pea sized amount 2 times per week from week 1 postpartum to 3 months postpartum.

Treatment:

Other: Placebo