Back to resultsUse of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion
Primary Purpose
Complete Miscarriage
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole
Misoprostol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Complete Miscarriage focused on measuring Letrozole, Misoprostol, First-Trimester, Pretreatment
Eligibility Criteria
Inclusion Criteria:
- Maternal age more than 18 years old (age of legal consent).
- Gestational age less than 13 weeks.
- Hemoglobin >10 g/dL.
- BMI between 25 kg/m2 and 35 kg/m2.
- Missed abortion.
- Living fetus with multiple congenital malformations incompatible with life.
Exclusion Criteria:
- Maternal age less than 18 years old.
- Gestational age more than 12 weeks.
- Hemoglobin <10 g/dL.
- Anencephaly.
- Fibroid uterus.
- BMI less than 25kg/m2 and more than 35kg/m2.
- Coagulopathy.
- History or evidence of adrenal pathology.
- Previous attempts for induction of abortion in the current pregnancy.
- Allergy to misoprostol or letrozole.
- Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
letrozole
placebo
Arm Description
Women will receive three tablets of letrozole(FemaraR, NOVARTIS) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.
Women will receive three tablets of placebo as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.
Outcomes
Primary Outcome Measures
Incidence of complete abortion
complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol
Secondary Outcome Measures
Need for surgical evacuation of the products of conception
Need for surgical evacuation of the products of conception
Incomplete expulsion of the products of conception (incomplete miscarriage).
Considerable bleeding necessitating immediate surgical evacuation.
Maternal morbidity
Maternal morbidity
Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
Minor side effects (fever, rigors, nausea, vomiting)
Hemoglobin and hematocrit deficit
Full Information
NCT ID
NCT02401425
First Posted
February 25, 2015
Last Updated
September 27, 2015
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT02401425
Brief Title
Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion
Official Title
Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion: Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
Detailed Description
Primary outcome:
Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol)
Secondary outcome:
Need for surgical evacuation of the products of conception
Incomplete expulsion of the products of conception (incomplete miscarriage).
Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity
Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Miscarriage
Keywords
Letrozole, Misoprostol, First-Trimester, Pretreatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
423 (Actual)
8. Arms, Groups, and Interventions
Arm Title
letrozole
Arm Type
Active Comparator
Arm Description
Women will receive three tablets of letrozole(FemaraR, NOVARTIS) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Women will receive three tablets of placebo as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
femara
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Misotac; Misotec; Cytotec
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Incidence of complete abortion
Description
complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Need for surgical evacuation of the products of conception
Description
Need for surgical evacuation of the products of conception
Incomplete expulsion of the products of conception (incomplete miscarriage).
Considerable bleeding necessitating immediate surgical evacuation.
Time Frame
1 week
Title
Maternal morbidity
Description
Maternal morbidity
Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion)
Minor side effects (fever, rigors, nausea, vomiting)
Time Frame
1 week
Title
Hemoglobin and hematocrit deficit
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:
Maternal age more than 18 years old (age of legal consent).
Gestational age less than 13 weeks.
Hemoglobin >10 g/dL.
BMI between 25 kg/m2 and 35 kg/m2.
Missed abortion.
Living fetus with multiple congenital malformations incompatible with life.
Exclusion Criteria:
Maternal age less than 18 years old.
Gestational age more than 12 weeks.
Hemoglobin <10 g/dL.
Anencephaly.
Fibroid uterus.
BMI less than 25kg/m2 and more than 35kg/m2.
Coagulopathy.
History or evidence of adrenal pathology.
Previous attempts for induction of abortion in the current pregnancy.
Allergy to misoprostol or letrozole.
Medical disorder that contraindicate induction of abortion (e.g. heart failure).
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt
12. IPD Sharing Statement
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Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion
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