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Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

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ClinicalTrials.gov Identifier: NCT03479879
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University

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

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Study Type : Interventional  (Clinical Trial)
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 : March 21, 2018
Actual Primary Completion Date : December 20, 2018
Actual Study Completion Date : December 20, 2018


Arm Intervention/treatment
Experimental: Estradiol + Misoprostol Drug: Estradiol
Estradiol

Drug: Misoprostol
Misoprostol

Placebo Comparator: Placebo + Misoprostol Drug: Placebo Oral Tablet
Placebo

Drug: Misoprostol
Misoprostol




Primary Outcome Measures :
  1. Duration of induction of abortion [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479879


Locations
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Egypt
Ain Shams University Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Mohamed S Sweed, MD, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT03479879     History of Changes
Other Study ID Numbers: AS1731
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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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:
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Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Abortion, Spontaneous
Pregnancy Complications
Misoprostol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics