NCT00410345

Brief Summary

Induction of midtrimester abortion includes cervical ripening and then contraction to induce uterine evacuation. There are several protocols, but most of them include using prostaglandins (PG). The disadvantages of using PG include uncomfortable side effects and limits of using it for women after cesarean section. Mifepristone is an antiprogesterone drug and been used for induction of abortion in first and second trimesters abortions. The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
145

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 1, 2017

Status Verified

May 1, 2008

Enrollment Period

3.8 years

First QC Date

December 11, 2006

Last Update Submit

February 28, 2017

Conditions

Abortion, Missed

Outcome Measures

Primary Outcomes (2)

  • success of abortion induction

  • abortion induction duration

Study Arms (2)

Pitocin

EXPERIMENTAL

Treatment with Pitocin after mifegine

Drug: Mifepristone

Cytotec

ACTIVE COMPARATOR

Treatment with cytotec after mifegine

Drug: Mifepristone

Interventions

MifepristoneDRUG
CytotecPitocin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • midtrimester late abortion
  • midtrimester induced abortion

You may not qualify if:

  • placenta previa
  • infected abortion
  • rupture of membranes
  • s/p cesarean section \*2 or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

MeSH Terms

Conditions

Abortion, Missed

Interventions

Mifepristone

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Assaf Ben-Meir, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

August 1, 2004

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

March 1, 2017

Record last verified: 2008-05

Locations

IL(1)