Back to resultsLetrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage
Primary Purpose
Missed Abortion
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
letrozole then misoprostol
placebo then misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Missed Abortion
Eligibility Criteria
Inclusion Criteria:
- Gestational age less than 64 days gestation (<9 wks).
- Hemoglobin >10 g/dL.
- BMI between 18.5 kg/m2 and 25 kg/m2.
- Missed abortion.
- previous one or more cesarean delivaries
Exclusion Criteria:
- Molar pregnancy.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
study group
control group
Arm Description
3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 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 two doses.
three 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 two doses
Outcomes
Primary Outcome Measures
induction to abortion time
induction to abortion time
Incidence of complete miscarriage
Incidence of complete miscarriage
Secondary Outcome Measures
Need for surgical evacuation of the products of conception
Need for surgical evacuation of the products of conception
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04215835
Brief Title
Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage
Official Title
Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 5, 2020 (Anticipated)
Primary Completion Date
April 5, 2020 (Anticipated)
Study Completion Date
April 10, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missed Abortion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 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 two doses.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
three 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 two doses
Intervention Type
Drug
Intervention Name(s)
letrozole then misoprostol
Intervention Description
Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Intervention Type
Drug
Intervention Name(s)
placebo then misoprostol
Intervention Description
Drug: Placebo placebo for 3 days
Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
Primary Outcome Measure Information:
Title
induction to abortion time
Description
induction to abortion time
Time Frame
6 hours
Title
Incidence of complete miscarriage
Description
Incidence of complete miscarriage
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Need for surgical evacuation of the products of conception
Description
Need for surgical evacuation of the products of conception
Time Frame
6 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age less than 64 days gestation (<9 wks).
Hemoglobin >10 g/dL.
BMI between 18.5 kg/m2 and 25 kg/m2.
Missed abortion.
previous one or more cesarean delivaries
Exclusion Criteria:
Molar pregnancy.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AHMED SAMY
Phone
+201100681167
Email
ahmedsamy8233@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED SAMY
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Letrozole Pretreatment With Misoprostol Induction of Abortion In First-Trimester Missed Miscarriage
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