NCT03044093

Brief Summary

Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2017

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

January 18, 2017

Last Update Submit

February 2, 2017

Conditions

Second Trimester Abortion

Outcome Measures

Primary Outcomes (1)

  • Reduction in Hospital Stay Duration

    number of days of hospital stay

    Up to 24 months

Study Arms (2)

MISOPROSTOL alone

ACTIVE COMPARATOR

the common practice currently in our medical center for second trimester medical abortion/ Placebo

Drug: PlaceboDrug: Misoprostol

Mifepristone and Misoprostol

EXPERIMENTAL

in addition to the common practice currently in our medical center for second trimester medical abortion we will add Mifepristone before administering Misoprostol. Mifepristone

Drug: MifepristoneDrug: Misoprostol

Interventions

MifepristoneDRUG

The group that will get in addition to Misoprostol also Mifepristone

Mifepristone and Misoprostol
PlaceboDRUG

The group that will only get Misoprostol

MISOPROSTOL alone
MisoprostolDRUG

Both groups will get think drug

MISOPROSTOL aloneMifepristone and Misoprostol

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • no allergy known to these drugs
  • second trimester abortion

You may not qualify if:

  • hematology diseases
  • clotting factor deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Campus

Haifa, Israel

RECRUITING

MeSH Terms

Interventions

MifepristoneMisoprostol

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsProstaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

MEIR NIZRI, MD

CONTACT

972-50-2061521

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

February 6, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

February 6, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)