Estradiol Pretreatment With Misoprostol in Second Trimester Miscarriage
1 other identifier
interventional
200
1 country
1
Brief Summary
To compare the effectiveness of estradiol pretreatment with misoprostol and vaginal misoprostol alone in induction of second trimestr miscarriage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2018
CompletedStudy Start
First participant enrolled
March 21, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2018
CompletedJanuary 29, 2019
January 1, 2019
9 months
March 21, 2018
January 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Duration of induction of abortion
24 hours
Study Arms (2)
Estradiol + Misoprostol
EXPERIMENTALPlacebo + Misoprostol
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain Shams University Maternity Hospital
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 21, 2018
First Posted
March 27, 2018
Study Start
March 21, 2018
Primary Completion
December 20, 2018
Study Completion
December 20, 2018
Last Updated
January 29, 2019
Record last verified: 2019-01