Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

NCT ID: NCT04217265

Last Updated: 2020-01-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-05

Study Completion Date

2020-04-10

Brief Summary

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This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy.

Detailed Description

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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

Conditions

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Missed Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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study group

2 tablets of Letrozole 2.5 mg will be given as single daily doses, 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 three doses.

Group Type EXPERIMENTAL

Letrozole then misoprostol

Intervention Type DRUG

total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion

control group

2 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 three doses

Group Type PLACEBO_COMPARATOR

placebo then misoprostol

Intervention Type DRUG

placebo tablets for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion

Interventions

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Letrozole then misoprostol

total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion

Intervention Type DRUG

placebo then misoprostol

placebo tablets for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion

Intervention Type DRUG

Eligibility Criteria

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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.
* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Samy aly ashour

assistant professor obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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AHMED SAMY

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Central Contacts

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AHMED SAMY

Role: CONTACT

+201100681167

Other Identifiers

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letrozole

Identifier Type: -

Identifier Source: org_study_id

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