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Letrozole versus Mifepristone in abortion.

Comparison of Letrozole and Mifepristone pre-treatment in first trimester medication abortion- a non-inferiority randomized controlled trial. - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070514
Enrollment
294
Registered
2024-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O021- Missed abortion

Interventions

Intervention1: letrozole pretreatment: patients in the letrozole group will get 10 mg of letrozole orally three days in a row, followed by 800 mg of misoprostol given sublingually on the morning of th

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1) women aged 18-45 years at 6–12 complete weeks of gestation seeking medication abortion (2) having singleton pregnancy (3) agreeing to participate in the trial voluntarily (4) having no contraindications to medical abortion.

Exclusion criteria

Exclusion criteria: (1) incomplete, missed or inevitable miscarriage (defined by the clinical finding of an open cervix and bleeding) (2) suspected ectopic pregnancy, (3) history of heart, liver, kidney disease or adrenal insufficiency, (4) abnormal uterine lesions such as adenomyosis, fibroids or congenital malformations or intrauterine adhesion (5) pregnancy with an intrauterine contraceptive device in situ (6) history of coagulatory dysfunction or intake of anticoagulant drugs and

Design outcomes

Primary

MeasureTime frame
proportion of complete expulsion rate with mifepristone and letrozole Timepoint: immediately after intervention, at 7 days and 15 days

Secondary

MeasureTime frame
need for surgical evacuation Timepoint: at 15 days;time of expulsion of product of conception Timepoint: at 3 days and every 24 hours thereafter

Countries

India

Contacts

Public ContactDR SUDWITA SINHA

AIIMS Patna

dr.sudwita11133@aiimspatna.org07633071844

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026