Drospirenone Only Pills and Cervical Mucus Changes in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Cervical mucus by modified Insler score
研究概览
简要总结
The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery
详细描述
After being informed about the study and potential risks, all participants giving written informed consent who meet the eligibility requirements will take Drospirenone-only pills (4 mg, once daily). Cervical mucus by modified Insler score will be evaluated on Day 4-7 of Drospirenone taking. Pre-bariatric surgery results will be compared with post-bariatric surgery results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Thai women aged 18-45 years who are obese and had an appointment for Bariatric surgery at Chulalongkorn Hospital
- •Need contraception
- •Able to use non-hormonal contraception during the study
- •Giving consent
排除标准
- •Pregnancy or history of giving birth within 3 months
- •Breastfeeding within the 6 months
- •History of using DMPA within 12 months
- •History of using other types of hormonal birth control pills within 4 weeks
- •History of bilateral oophorectomy or hysterectomy
- •Suspected ovarian tumor or pathological ovarian cyst
- •Regular cigarette smoking
- •Contraindications to Drospirenone
研究组 & 干预措施
Drospirenone
Participants received Drospirenone 4 mg tablet orally once daily for 21-28 days
干预措施: Drospirenone (Drug)
结局指标
主要结局
Cervical mucus by modified Insler score
时间窗: 1 month before and 1 month after bariatric surgery
Modified Insler score (ferning, spinnbarkeit, viscosity, cellularity) according to the World Health Organization (WHO) guidelines 2010 used for prediction and detection of ovulation. Score ≥9 favoring fertility, 5-8 intermediate, and ≤4 unfavorable to fertility Comparing pre-bariatric surgery with post-bariatric surgery
次要结局
- Number of Participants With Treatment-Related Adverse Events(1 month)
- Estrogen and progesterone levels versus time(1 month before and 1 month after bariatric surgery)