Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

Ain Shams University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Miscarriage

Treatments: Drug: Estradiol; Drug: Misoprostol; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03479879

AS1731

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Estradiol + Misoprostol

Experimental group

Treatment:

Drug: Estradiol

Drug: Misoprostol

Placebo + Misoprostol

Placebo Comparator group

Treatment:

Drug: Placebo Oral Tablet

Drug: Misoprostol