Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Miscarriage
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Estradiol; Drug: Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Estradiol + Misoprostol	Drug: Estradiol; Estradiol; Drug: Misoprostol; Misoprostol
Placebo Comparator: Placebo + Misoprostol	Drug: Placebo Oral Tablet; Placebo; Drug: Misoprostol; Misoprostol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Duration of induction of abortion	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): December 20, 2018
• Study Completion (Actual): December 20, 2018

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 26, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Estradiol; Misoprostol
• Other Study ID Numbers: AS1731

Drug and device information, study documents

• 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