A clinical trial comparing the safety and efficacy of mifepristone and misoprostol either alone or when used with an intracervical Foleys catheter in women desiring second-trimester medical abortions
Phase 2
- Conditions
- Health Condition 1: O00-O08- Pregnancy with abortive outcome
- Registration Number
- CTRI/2024/06/069578
- Lead Sponsor
- Dr Lakshyaa Chawla
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Pregnant women seeking MTP between 16 to 24 weeks of gestation including women with previous one LSCS
2. Age =18 years
3. Single intrauterine viable pregnancy
4. Women fulfilling the pre-requisites of MTP amendment act, 2021 (India)
Exclusion Criteria
1.Prior 2 or more uterine surgeries
2.Contraindications to mifepristone or misoprostol: ectopic pregnancy, inherited porphyria, chronic adrenal failure, on immunosuppressants (on corticosteroids), coagulation disorders
3.Chorioamnionitis or vaginal infections
4.Any medical or surgical disorders like heart disease , uncontrolled hypertension (=160/100 mm Hg) or diabetes, bronchial asthma or any other medical illness
5.Haemoglobin =8 Gm/dl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method