Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage
NCT ID: NCT04593108
Last Updated: 2020-10-20
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
320 participants
OBSERVATIONAL
2019-01-15
2020-11-15
Brief Summary
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Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
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Detailed Description
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Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
Primary outcome:
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
Secondary outcome:
• Curettage (surgical evacuation of the products of conception)
* Incomplete abortion (retained products of conception).
* Considerable bleeding that necessitates immediate evacuation.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Letrozole misoprostol
Group (A):
A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start
Letrozole misoprostol
Letrozole give pretreatment of abortion by misoprostol
Misoprostol,placebo
Group (B):
A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start
Misoprostol, placebo
Give placebo pretreatment of abortion by misoprostol
Interventions
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Letrozole misoprostol
Letrozole give pretreatment of abortion by misoprostol
Misoprostol, placebo
Give placebo pretreatment of abortion by misoprostol
Eligibility Criteria
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Inclusion Criteria
* BMI ranges between 25 kg/m2 and 35 kg/m2.
* Gestational age of 63 days' gestation (or less).
* Missed abortion.
* Hemoglobin leve
Exclusion Criteria
* BMI less than 25 kg/m2 or more than 35 kg/m2.
* Gestational age more than 63 days' gestation.
* Molar pregnancy.
* Hemoglobin level less than 10 gm/dL.
* Fibroid uterus.
* Uterus with congenital anomalies.
* Previous attempts for induction of abortion in the current pregnancy.
* Coagulation defect i.e. coagulopathy.
* Contraindication for induction of abortion e.g. heart failure.
* Allergy to misoprostol or letrozole.
18 Years
35 Years
FEMALE
Yes
Sponsors
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Benha University
OTHER
Dr.Dalia Mohammed Al Sayed Zaki
OTHER
Responsible Party
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Dr.Dalia Mohammed Al Sayed Zaki
Banha university
Principal Investigators
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Zagazig General hospital, Ministry hospital
Role: PRINCIPAL_INVESTIGATOR
Zagazig general hospital
Locations
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Dalia Mohammed Al Sayed Zaki
Zagazig, Sharqia Province, Egypt
Countries
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References
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Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.
Study Documents
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Document Type: Individual Participant Data Set
Albrecht ED, Aberdeen GW, Pepe GJ, (2000). The role of estrogen in the maintenance of primate pregnancy. Am J Obstet Gynecol. 182:432-8. Albrecht ED, Robb VA, Pepe GJ, (2004). Regulation of placental vascular endothelial growth permeability factor expression and angiogenesis by estrogen during early baboon pregnancy. J Clin Endocrinol Metab. 89:
View DocumentRelated Links
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Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial
Other Identifiers
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Treatment of missedmiscarriage
Identifier Type: -
Identifier Source: org_study_id
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