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A study comparing two medicines letrozole and mifepristone used before misoprostol for the treatment of abortion

Randomized controlled trial comparing letrozole versus mifepristone for pretreatment in medical management of first trimester missed abortion - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094475
Enrollment
82
Registered
2025-09-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: O034- Incomplete spontaneous abortion without complication

Interventions

Intervention1: Letrozol: group 1 patient will take an oral dose of letrozole 10 mg once daily for three consecutive days in ward. On the morning of third dose. they will receive 800 mcg of vaginal mis

Sponsors

Dr Vandana Devi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Hemodynamically stable patient 2.Gestational age up to 12 complete weeks of gestation by LMP and missed - abortion confirmed by following USG criteria [USG findings CRL more than 7mm and no heartbeat or mean sac diameter (MSD) more than 25 mm no embryo visualized] Hb 9 g/dl,

Exclusion criteria

Exclusion criteria: 1.Known hypersensitivity to letrozole or misoprostol, mifepristone 2.Known case of heart, liver, kidney disease and adrenal insufficiency 3.History of bleeding disorder or intake of anticoagulant drug 4.History of previous 2 LSCS or more, history of myomectomy or other uterine surgery 5.Diagnosed case of uterine fibroid, uterine anomalies

Design outcomes

Primary

MeasureTime frame
9.To determine the efficacy of letrozole versus mifepristone as a pretreatment in management of first trimester missed abortion in terms of Induction to expulsion interval need for surgical interventions Timepoint: baseline follow by 2 week

Secondary

MeasureTime frame
1. To evaluate and compare the following complications and side effects in both the groups a Abnormal uterine bleeding b Pain abdomen Retained product of conception after day 14 Timepoint: 14 days after expulsion

Countries

India

Contacts

Public ContactDr Rashmi Khatri

Baba Saheb Ambedkar Hospital Rohini new Delhi

sneeraj90@yahoo.com09560653463

Outcome results

None listed

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