Actively Recruiting
Phase Not Applicable
Age: 18Years - 45Years
FEMALE
ID06345586
Drospirenone Only Pills and Cervical Mucus Changes in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study
Led by Chulalongkorn University · Updated on 2026-03-18
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effect of Drospirenone on cervical mucus changes in obese Thai women undergoing bariatric surgery. The study specifically evaluates cervical mucus using the modified Insler score before and after bariatric surgery to understand how the hormone-only pill impacts cervical mucus in this population. Participants will take a Drospirenone-only pill (4 mg) once daily for 21 to 28 days. Cervical mucus will be assessed on days 4 to 7 of taking the medication. The study compares results from one month before bariatric surgery with results from one month after the surgery to observe any differences. Throughout the study, participants will provide cervical mucus samples for scoring, and hormone levels of estrogen and progesterone will be measured over time before and after surgery. Researchers will also monitor any treatment-related adverse events during the one-month period. The trial is expected to continue until July 2026, with all evaluations occurring close to the bariatric surgery timeline.
CONDITIONS
Brief Title
Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study
Who Can Participate
Age: 18Years - 45Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Thai women aged 18 to 45 years who are obese and scheduled for bariatric surgery at Chulalongkorn Hospital
- Need contraception
- Able to use non-hormonal contraception during the study
- Able and willing to give consent
You will not qualify if you...
- Currently pregnant or have given birth within the past 3 months
- Breastfeeding within the past 6 months
- History of using DMPA within the past 12 months
- History of using other hormonal birth control pills within the past 4 weeks
- History of bilateral oophorectomy or hysterectomy
- Suspected ovarian tumor or pathological ovarian cyst
- Regular cigarette smoking
- Any contraindications to Drospirenone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 21 to 28 days
Participants take Drospirenone 4 mg tablet orally once daily for 21 to 28 days. Cervical mucus is evaluated during this period.
1 baseline visit and 1 follow-up visit during treatment
Treatment
Duration - 21 to 28 days
Participants take Drospirenone 4 mg tablet orally once daily for 21 to 28 days after bariatric surgery. Cervical mucus is evaluated during this period.
1 baseline visit and 1 follow-up visit during treatment
Trial Site Locations
Total: 1 location
1
Chulalongkorn University
Bangkok, Thailand, 10330
Actively Recruiting
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Research Team
P
Punyawee Utaipatanacheep
S
Somsook Santibenchakul
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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Published Research Related To This Trial
Clinical Practice Guidelines for Childbearing Female Candidates for Bariatric Surgery, Pregnancy, and Post-partum Management After Bariatric Surgery.
Cécile Ciangura, Muriel Coupaye, Philippe Deruelle...
https://pubmed.ncbi.nlm.nih.gov/31493139Clinical Practice Guidelines for the Perioperative Nutrition, Metabolic, and Nonsurgical Support of Patients Undergoing Bariatric Procedures - 2019 Update: Cosponsored by American Association of Clinical Endocrinologists/American College of Endocrinology, The Obesity Society, American Society for Metabolic and Bariatric Surgery, Obesity Medicine Association, and American Society of Anesthesiologists.
Jeffrey I Mechanick, Caroline Apovian, Stacy Brethauer...
https://pubmed.ncbi.nlm.nih.gov/32202076Perioperative pregnancy interval, contraceptive counseling experiences, and contraceptive use in women undergoing bariatric surgery.
Biftu M Mengesha, Jonathan T Carter, Christine E Dehlendorf...
https://pubmed.ncbi.nlm.nih.gov/29634911The effects of age, body mass index, smoking and general health on the risk of venous thromboembolism in users of combined oral contraceptives.
A L Nightingale, R A Lawrenson, E L Simpson...
https://pubmed.ncbi.nlm.nih.gov/11245554Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components.
H Jick, S S Jick, V Gurewich...
https://pubmed.ncbi.nlm.nih.gov/7500750Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.
https://pubmed.ncbi.nlm.nih.gov/7500749Obesity and contraceptive use: impact on cardiovascular risk.
Giuseppe M C Rosano, Maria Angeles Rodriguez-Martinez, Ilaria Spoletini...
https://pubmed.ncbi.nlm.nih.gov/36103980Cardiovascular disease and use of oral and injectable progestogen-only contraceptives and combined injectable contraceptives. Results of an international, multicenter, case-control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.
https://pubmed.ncbi.nlm.nih.gov/9673838Risk of idiopathic venous thromboembolism in users of progestagens alone.
C Vasilakis, H Jick, M del Mar Melero-Montes
https://pubmed.ncbi.nlm.nih.gov/10560680