Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

Miscarriage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479879
• Other study ID #: AS1731
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 21, 2018
• Est. completion date: December 20, 2018

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage

Intervention

Drug:
• Estradiol
Estradiol
• Placebo Oral Tablet
Placebo
• Misoprostol
Misoprostol

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of induction of abortion		24 hours