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Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03479879
Enrollment
200
Registered
2018-03-27
Start date
2018-03-21
Completion date
2018-12-20
Last updated
2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscarriage

Brief summary

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

Interventions

DRUGEstradiol

Estradiol

DRUGPlacebo Oral Tablet

Placebo

DRUGMisoprostol

Misoprostol

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
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

* 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).

Design outcomes

Primary

MeasureTime frame
Duration of induction of abortion24 hours

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026