Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
Primary Purpose
Miscarriage, Missed Abortion
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole 2.5mg
Placebo
Misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Miscarriage
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.
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
- Ain Shams University, Maternity HospitalRecruiting
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
Incidence of complete miscarriage
Secondary Outcome Measures
Need for surgical evacuation of the products of conception
Incidence of Septic Abortion
Full Information
NCT ID
NCT03628625
First Posted
May 10, 2018
Last Updated
October 5, 2018
Sponsor
Ain Shams Maternity Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03628625
Brief Title
Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
Official Title
Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
December 5, 2018 (Anticipated)
Study Completion Date
December 10, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
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.
Detailed Description
According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period
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
Hypothesis:
In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage, Missed Abortion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (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 2.5mg
Intervention Description
total dose 7.5 mg per day for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Folic acid for 3 days
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Misoprosrol 800mcg will be given to all patients for induction of abortion
Primary Outcome Measure Information:
Title
Incidence of complete miscarriage
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Need for surgical evacuation of the products of conception
Time Frame
6 hours
Title
Incidence of Septic Abortion
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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
Dina Mansour
Phone
+20100657
Email
Dinayahiamansour@hotmail.com
Facility Information:
Facility Name
Ain Shams University, Maternity Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Mansour
12. IPD Sharing Statement
Learn more about this trial
Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
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