Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

NCT ID: NCT04590482

Last Updated: 2020-10-29

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2021-05-08

Brief Summary

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this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Detailed Description

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Intervention type: drug

Intervention name: letrozole then misoprostol

Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion

Arm group label:study group

Intervention type :drug

Intervention name:placebo then misoprostol

Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion

Arm group label: control group

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
participant- care provider -investigator- outcomes assessor

Study Groups

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letrozole then misoprostol

description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed

Group Type EXPERIMENTAL

letrozole

Intervention Type DRUG

Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion

placebo then misoprostol

Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion

Interventions

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letrozole

Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion

Intervention Type DRUG

placebo

placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Maternal age more than 18 years old.
2. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study.
3. Hemoglobin \>10 g/dl
4. Missed abortion

Exclusion Criteria

1. Mullerian Uterine anomalies as septate, bicornuate uterus.
2. Fibroid uterus.
3. Coagulopathy.
4. Medical disorder that contraindicate induction of abortion.
5. Allergy to misoprostol or letrozole.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Shereen Rady Abou El-fetouh

OTHER

Sponsor Role lead

Responsible Party

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Shereen Rady Abou El-fetouh

principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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shereen khedr

Role: PRINCIPAL_INVESTIGATOR

AinShams University

Central Contacts

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shereen khedr

Role: CONTACT

01011304478

Other Identifiers

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Letrozole /pretreatment

Identifier Type: -

Identifier Source: org_study_id