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CompletedNCT03479879Updated Jan 29, 2019

Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

A Phase 2/3 interventional study of Estradiol and Placebo Oral Tablet in Miscarriage, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-01-29.

Sponsored by Ain Shams University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Miscarriage

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03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
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

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).
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    Estradiol + Misoprostol

    Drug: Estradiol · Drug: Misoprostol

  • Placebo comparator
    Placebo + Misoprostol

    Drug: Placebo Oral Tablet · Drug: Misoprostol

Interventions

  • DrugEstradiol

    Estradiol

  • DrugPlacebo Oral Tablet

    Placebo

  • DrugMisoprostol

    Misoprostol

05

What researchers measure

Primary outcomes

  1. Duration of induction of abortion

    Time frame: 24 hours

06

Study locations

1 site
  • Ain Shams University Maternity Hospital
    Cairo, Egypt
07

Registry details

Key details

Study ID
NCT03479879
Lead sponsor
Ain Shams University
Responsible party
Mohamed S Sweed, MD (Principal Investigator, Ain Shams University) — Principal investigator
First posted
Mar 27, 2018
Start date
Mar 21, 2018
Primary completion
Dec 20, 2018
Completion
Dec 20, 2018
Last update
Jan 29, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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