Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

Overview

To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.

Full Title of Study: “Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial”

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: December 20, 2018

Interventions

  • Drug: Estradiol
    • Estradiol
  • Drug: Placebo Oral Tablet
    • Placebo
  • Drug: Misoprostol
    • Misoprostol

Arms, Groups and Cohorts

  • Experimental: Estradiol + Misoprostol
  • Placebo Comparator: Placebo + Misoprostol

Clinical Trial Outcome Measures

Primary Measures

  • Duration of induction of abortion
    • Time Frame: 24 hours

Participating in This Clinical Trial

Inclusion Criteria

  • Maternal age more than 18 years old (age of legal consent). – Gestational age between 12-26 weeks. – Hb level > 10 g/dL. – BMI between 25 kg/m2 and 35 kg/m2. – Missed abortion. – Living fetus with multiple congenital malformations incompatible with life. – PPROMS with drained liquor and parents are consenting for termination of pregnancy. Exclusion Criteria:

  • Maternal age less than 18 years old. – Gestational age less than 12 weeks or more than 26 weeks. – Hb level < 10 g/dL. – Scared uterus (previous myomectomy – cesarean section – hysterectomy and ruptured uterus). – Polyhydramnios. – Anencephaly. – Fibroid uterus. – BMI less than 25 kg/m2 and more than 35 kg/m2. – Coagulopathy. – Previous attempts for induction of abortion in the current pregnancy. – Allergy to misoprostol or estradiol. – Placenta previa. – Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mohamed S Sweed, MD, Principal Investigator – Ain Shams University

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