Letrozole
Conditions
Brief summary
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
PROCEDUREIntervention Group: letrozole followed by misoprostol
Group A (Intervention Group) will receive letrozole followed by misoprostol.
PROCEDUREControl Group: misoprostol only
Group B (Control Group) will receive misoprostol only, without prior letrozole pretreatment
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time of complete uterine evacuation | one week following Misoprostol administration | Time from misoprostol administration to complete uterine evacuation |
Outcome results
None listed