Contraception
Conditions
Keywords
Drospirenone only pills, Obesity, Bariatric surgery, Roux-en-Y gastric bypass, Cervical mucus
Brief summary
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
Detailed description
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.
Interventions
DRUGDrospirenone
4 mg tablet once daily
Sponsors
Chulalongkorn University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Participants received Drospirenone will be assess for cervical mucus change by modified Insler score
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cervical mucus by modified Insler score | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estrogen and progesterone levels versus time | 1 month before and 1 month after bariatric surgery | Serum estrogen and progesterone levels will be measured to evaluate change over time (pattern and value) and assess ovulation |
| Number of Participants With Treatment-Related Adverse Events | 1 month | — |
Countries
Thailand
Contacts
CONTACTPunyawee Utaipatanacheep
CONTACTSomsook Santibenchakul
PRINCIPAL_INVESTIGATORPunyawee Utaipatanacheep
Chulalongkorn University
Outcome results
None listed