Postpartum Vaginal Estrogen

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

Sexual dysfunction is very common in the postpartum period and is more common in people who breastfeed or pump. This research study was designed to help determine whether postpartum patients who use vaginal estrogen cream while breastfeeding have improved sexual function compared to postpartum patients who do not.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospitals Cleveland Medical Center
• Treatments: Estradiol

Criteria

Inclusion Criteria:

• Age 18 or older

• Sexually active

• Singleton, term (37 weeks 0 days) birth

• Planning to breastfeed or pump during the study period

• Ability to consent in English

• Between 6 weeks and 6 months postpartum (patients may be recruited at any time during the postpartum period, but the study period will not start until 6 weeks postpartum)

• Not meeting any exclusion criteria

Exclusion Criteria:

• Preterm delivery

• Perinatal mortality

• History of difficulty breastfeeding

• 3rd or 4th degree perineal laceration

• Any contraindications to estrogen, including, but not limited to, breast cancer or a history of breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis (DVT)/pulmonary embolism (PE) or a history of these conditions, active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions, known anaphylactic reaction, angioedema, or hypersensitivity to estrogen, hepatic impairment or disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.