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Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

Primary Purpose

Miscarriage

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Estradiol
Placebo Oral Tablet
Misoprostol
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Miscarriage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Estradiol + Misoprostol

Placebo + Misoprostol

Arm Description

Outcomes

Primary Outcome Measures

Duration of induction of abortion

Secondary Outcome Measures

Full Information

First Posted
March 21, 2018
Last Updated
January 26, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03479879
Brief Title
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage
Official Title
Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2018 (Actual)
Primary Completion Date
December 20, 2018 (Actual)
Study Completion Date
December 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Estradiol + Misoprostol
Arm Type
Experimental
Arm Title
Placebo + Misoprostol
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Estradiol
Intervention Description
Estradiol
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Misoprostol
Primary Outcome Measure Information:
Title
Duration of induction of abortion
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

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