Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study

ConditionContraception
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorChulalongkorn University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Drospirenone

    Drug

    4 mg tablet once daily

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: DrospirenoneExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cervical mucus by modified Insler score

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

Time frame
1 month before and 1 month after bariatric surgery

Secondary outcomes

1

Estrogen and progesterone levels versus time

Serum estrogen and progesterone levels will be measured to evaluate change over time (pattern and value) and assess ovulation

Time frame
1 month before and 1 month after bariatric surgery
2

Number of Participants With Treatment-Related Adverse Events

Time frame
1 month

Other outcomes

Sponsors and contacts

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