Not yet recruiting NCT07753655
The Value of Pretreatment With Letrozole on Induction Time of Medical Evacuation With Misoprostol in Cases of Missed Abortion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention Group: letrozole followed by misoprostol, Control Group: misoprostol only.
- Who it may be relevant to
- Registry conditions: Letrozole. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The aim is to evaluate the effect of letrozole pretreatment on the induction time during medical evacuation using misoprostol in women diagnosed with missed abortion, and to compare its efficacy and safety to misoprostol alone.
Interventions
- Procedure Intervention Group: letrozole followed by misoprostol
Group A (Intervention Group) will receive letrozole followed by misoprostol. - Procedure Control Group: misoprostol only
Group B (Control Group) will receive misoprostol only, without prior letrozole pretreatment
Primary outcome measures
- Time of complete uterine evacuation [Time frame: one week following Misoprostol administration]
Eligibility criteria
Inclusion criteria
- Women aged 18 - 45 years.
- Diagnosed with missed abortion confirmed by ultrasound (absent fetal heartbeat and/or no embryonic development).
- Gestational age ≤ 12 weeks based on last menstrual period
- Hemoglobin levels >10 g/dL.
- BMI ranging from 25 to 35 kg/m2.
- Hemodynamically stable and no signs of infection.
Exclusion criteria
- Incomplete abortion, inevitable abortion, or threatened miscarriage.
- Suspected ectopic pregnancy and molar pregnancy.
- History of allergy or contraindication to misoprostol or letrozole.
- Coagulopathy or use of anticoagulant medications.
- Chronic medical diseases (e.g., uncontrolled diabetes, cardiovascular disease, liver or renal dysfunction).
- Prior uterine surgery that contraindicates medical abortion (e.g., classical cesarean section, myomectomy with uterine entry).
- Uterine anomalies.
- Women unsure of LMP
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07753655 · MS-616-2025