Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion
NCT ID: NCT04590482
Last Updated: 2020-10-29
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
110 participants
INTERVENTIONAL
2020-11-15
2021-05-08
Brief Summary
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Detailed Description
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Intervention name: letrozole then misoprostol
Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion
Arm group label:study group
Intervention type :drug
Intervention name:placebo then misoprostol
Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion
Arm group label: control group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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letrozole then misoprostol
description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed
letrozole
Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion
placebo then misoprostol
Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed
placebo
placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion
Interventions
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letrozole
Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion
placebo
placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion
Eligibility Criteria
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Inclusion Criteria
2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
3. Hemoglobin \>10 g/dl
4. Missed abortion
Exclusion Criteria
2. Fibroid uterus.
3. Coagulopathy.
4. Medical disorder that contraindicate induction of abortion.
5. Allergy to misoprostol or letrozole.
\-
18 Years
42 Years
FEMALE
Yes
Sponsors
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Shereen Rady Abou El-fetouh
OTHER
Responsible Party
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Shereen Rady Abou El-fetouh
principal investigator
Principal Investigators
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shereen khedr
Role: PRINCIPAL_INVESTIGATOR
AinShams University
Central Contacts
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Other Identifiers
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Letrozole /pretreatment
Identifier Type: -
Identifier Source: org_study_id