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

Primary Purpose

Missed Abortion

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
letrozole
placebo
Sponsored by
Shereen Rady Abou El-fetouh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missed Abortion

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

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.

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    letrozole then misoprostol

    placebo then misoprostol

    Arm Description

    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

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

    Outcomes

    Primary Outcome Measures

    Complete abortion
    incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol

    Secondary Outcome Measures

    surgical evacuation
    surgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol

    Full Information

    First Posted
    August 23, 2020
    Last Updated
    October 27, 2020
    Sponsor
    Shereen Rady Abou El-fetouh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04590482
    Brief Title
    Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion
    Official Title
    Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 15, 2020 (Anticipated)
    Primary Completion Date
    March 16, 2021 (Anticipated)
    Study Completion Date
    May 8, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Shereen Rady Abou El-fetouh

    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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Missed Abortion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    participant- care provider -investigator- outcomes assessor
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    letrozole then misoprostol
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    placebo then misoprostol
    Arm Type
    Placebo Comparator
    Arm Description
    Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed
    Intervention Type
    Drug
    Intervention Name(s)
    letrozole
    Intervention Description
    Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion
    Primary Outcome Measure Information:
    Title
    Complete abortion
    Description
    incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol
    Time Frame
    6 hours
    Secondary Outcome Measure Information:
    Title
    surgical evacuation
    Description
    surgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol
    Time Frame
    6 hours

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Ages of eligibility :18years and older sex eligibility :female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Maternal age more than 18 years old. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study. Hemoglobin >10 g/dl Missed abortion Exclusion Criteria: Mullerian Uterine anomalies as septate, bicornuate uterus. Fibroid uterus. Coagulopathy. Medical disorder that contraindicate induction of abortion. Allergy to misoprostol or letrozole. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    shereen khedr
    Phone
    01011304478
    Email
    a.m.agdy@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    shereen khedr
    Organizational Affiliation
    AinShams University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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