Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total Female Sexual Function Index (FSFI) score
研究概览
简要总结
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.
详细描述
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 preferred form of communication. Inclusion criteria and desire for continued study participation will be verified prior to randomization. A baseline REDCap questionnaire will be texted or emailed to confirmed study participants. UH REDCap is a HIPAA-certified, secure, web-based data storage platform for research studies.
The patient will then be randomized in a 1:1 ratio into two study groups: vaginal estrogen or vaginal moisturizer. Randomization will be performed using blocking with a block size of 10 and a 1:1 allocation ratio. The randomization sequence will be generated using a random number table.
After randomization, but not prior to 6 weeks postpartum, the investigational drug service courier service will deliver softgel inserts of vaginal estrogen to the homes of participants randomized to the estrogen arm. Study investigators will deliver vaginal moisturizer to the homes of participants randomized to the placebo arm. Study participants will be provided with an instructional handout including information about how and how often to use the inserts or the moisturizer. Participants will be instructed to start using the inserts or lubricant when they receive the delivery. This will be considered the start of the study period.
During the study period, participants will use either estrogen or vaginal moisturizer nightly for two weeks and then twice weekly for ten weeks. Each week during the study period, participants will receive a message via their preferred communication method with five questions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Vaginal Estrogen
Estradiol 4 mcg vaginal insert, daily for two weeks then twice weekly for ten weeks.
干预措施: Estradiol (Drug)
Vaginal Moisturizer
Vaginal moisturizer, daily for two weeks then twice weekly for ten weeks.
干预措施: Vaginal Moisturizer (Device)
结局指标
主要结局
Total Female Sexual Function Index (FSFI) score
时间窗: Up to 12 weeks into study period
Female Sexual Function Index (FSFI) overall score has six domains and a maximum score of 36, with a higher score indicating better functioning. A score of 26 has been validated as a threshold for diagnosing female sexual dysfunction.
次要结局
- Pain as measured by Female Sexual Function Index (FSFI)(Up to 12 weeks into study period)
- Intercourse resumption(Up to 12 weeks into study period)
- Desire as measured by Female Sexual Function Index (FSFI)(Up to 12 weeks into study period)
- Arousal as measured by Female Sexual Function Index (FSFI)(Up to 12 weeks into study period)
- Lubrication as measured by Female Sexual Function Index (FSFI)(Up to 12 weeks into study period)
- Orgasm as measured by Female Sexual Function Index (FSFI)(Up to 12 weeks into study period)
- Satisfaction as measured by Female Sexual Function Index (FSFI)(Up to 12 weeks into study period)
- Serum estradiol levels(Up to 12 weeks after study medication initiation)
- Breast milk estradiol level(Up to 12 weeks after study medication initiation)
研究者
Rachel Pope
Physician
University Hospitals Cleveland Medical Center