Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion
NCT ID: NCT04217265
Last Updated: 2020-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2020-01-05
2020-04-10
Brief Summary
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Detailed Description
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Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week
letrozole administration with misoprostol raises the rate of complete abortion
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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study group
2 tablets of Letrozole 2.5 mg will be given as single daily doses, 5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum three doses.
Letrozole then misoprostol
total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
control group
2 tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum three doses
placebo then misoprostol
placebo tablets for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
Interventions
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Letrozole then misoprostol
total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
placebo then misoprostol
placebo tablets for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
Eligibility Criteria
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Inclusion Criteria
* Hemoglobin \>10 g/dL.
* BMI between 18.5 kg/m2 and 25 kg/m2.
* Missed abortion.
Exclusion Criteria
* Fibroid uterus.
* Uterine anomalies.
* Coagulopathy.
* Medical disorder that contraindicate induction of abortion (e.g. heart failure).
* Previous attempts for induction of abortion in the current pregnancy.
* Allergy to misoprostol or letrozole.
* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
18 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Principal Investigators
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AHMED SAMY
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Central Contacts
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Other Identifiers
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letrozole
Identifier Type: -
Identifier Source: org_study_id
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