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Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

Primary Purpose

Missed Abortion

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Letrozole then misoprostol
placebo then misoprostol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Missed Abortion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    study group

    control group

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    complete abortion rate
    Incidence of complete miscarriage
    time from induction to abortion
    induction to abortion time interval

    Secondary Outcome Measures

    Need for surgical evacuation of the products of conception
    how many women will undergo dilatation and curettage after failed medical induction of abortion

    Full Information

    First Posted
    December 30, 2019
    Last Updated
    January 1, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04217265
    Brief Title
    Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion
    Official Title
    Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 5, 2020 (Anticipated)
    Primary Completion Date
    April 5, 2020 (Anticipated)
    Study Completion Date
    April 10, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

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

    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
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Letrozole then misoprostol
    Intervention Description
    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
    Intervention Name(s)
    placebo then misoprostol
    Intervention Description
    placebo tablets for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
    Primary Outcome Measure Information:
    Title
    complete abortion rate
    Description
    Incidence of complete miscarriage
    Time Frame
    9 hours
    Title
    time from induction to abortion
    Description
    induction to abortion time interval
    Time Frame
    9 hours
    Secondary Outcome Measure Information:
    Title
    Need for surgical evacuation of the products of conception
    Description
    how many women will undergo dilatation and curettage after failed medical induction of abortion
    Time Frame
    9 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    AHMED SAMY
    Phone
    +201100681167
    Email
    ahmedsamy8233@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AHMED SAMY
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

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