Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03479879
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 9
• Patients Per Site Per Month: 22.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Miscarriage	Drug: Estradiol; Drug: Placebo Oral Tablet; Drug: Misoprostol	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial
• Actual Study Start Date: Mar 21, 2018
• Actual Primary Completion Date: Dec 20, 2018
• Actual Study Completion Date: Dec 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Duration of induction of abortion [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Maternity Hospital	Cairo		Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed S Sweed, MD, Principal Investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT03479879
• Other Study ID Numbers: AS1731
• First Posted: Mar 27, 2018
• Last Update Posted: Jan 29, 2019
• Last Verified: Jan 1, 2019

• 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
• Additional relevant MeSH terms: Abortion, Spontaneous; Misoprostol; Estradiol

Study Results

No Results Posted as of Jan 29, 2019