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Completed

NCT Number: NCT03479879

Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

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

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Key information

Conditions

Miscarriage Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Estradiol

Drug

Estradiol

Placebo oral tablet

Drug

Placebo

Misoprostol

Drug

Misoprostol

Primary outcomes

  1. Duration of induction of abortion

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage: A Prospective, Double-blind, Randomized Clinical Trial

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 27, 2018
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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