Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial
University Hospitals Cleveland Medical Center
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.
Description
This will be a prospective, randomized clinical trial of postpartum breastfeeding patients. Postpartum patients at University Hospitals (UH) MacDonald Women's Hospital will be evaluated for inclusion/exclusion by review of their medical record by the study investigators prior to discharge home. The study will then be discussed with the eligible patients privately. If they agree to participate, informed consent will be obtained. At this time, contact information will be obtained for all consenting patients. Between 5 and 6 weeks postpartum, all consented patients will be contacted via their pr…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 or older * Sexually active * Singleton, term (37 weeks 0 days) birth * Planning to breastfeed or pump during the study period * History of successful breastfeeding or pumping after a prior pregnancy * 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) * Ability to consent in English * Not meeting any exclusion criteria Exclusion Criteria: * Preterm delivery * Perinatal mortality * History of difficulty breastfeeding * 3rd or 4th degree perineal…
Interventions
- DrugEstradiol
Imvexxy is an FDA-approved drug produced by TherapeuticsMD.
- DeviceVaginal Moisturizer
Ingredients include hydrogenated coconut and palm oils and natural-source vitamin E (d-alpha tocopheryl acetate and tocopherols).
Location
- University Hospitals Cleveland Medical CenterCleveland, Ohio