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

Overview

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.

Full Title of Study: “Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 16, 2021

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

Interventions

  • Drug: letrozole
    • Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion
  • Drug: placebo
    • placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion

Arms, Groups and Cohorts

  • Experimental: 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
  • Placebo Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • Complete abortion
    • Time Frame: 6 hours
    • 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 Measures

  • surgical evacuation
    • Time Frame: 6 hours
    • 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

Participating in This Clinical Trial

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. -

Gender Eligibility: Female

Ages of eligibility :18years and older sex eligibility :female

Minimum Age: 18 Years

Maximum Age: 42 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shereen Rady Abou El-fetouh
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Shereen Rady Abou El-fetouh, principal investigator – Ain Shams University
  • Overall Official(s)
    • shereen khedr, Principal Investigator, AinShams University
  • Overall Contact(s)
    • shereen khedr, 01011304478, a.m.agdy@hotmail.com

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