- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03479879
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage
January 26, 2019 updated by: Mohamed S Sweed, MD, Ain Shams University
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Ain shams university maternity hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Estradiol + Misoprostol
|
Estradiol
Misoprostol
|
Placebo Comparator: Placebo + Misoprostol
|
Placebo
Misoprostol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Duration of induction of abortion
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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