Back to resultsCervical Rippening With Antiprogesterone in Midtrimester Abortions
Primary Purpose
Abortion, Missed
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Mifepristone
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Missed
Eligibility Criteria
Inclusion Criteria:
- midtrimester late abortion
- midtrimester induced abortion
Exclusion Criteria:
- placenta previa
- infected abortion
- rupture of membranes
- s/p cesarean section *2 or more
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pitocin
Cytotec
Arm Description
Treatment with Pitocin after mifegine
Treatment with cytotec after mifegine
Outcomes
Primary Outcome Measures
success of abortion induction
abortion induction duration
Secondary Outcome Measures
Full Information
NCT ID
NCT00410345
First Posted
December 11, 2006
Last Updated
February 28, 2017
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00410345
Brief Title
Cervical Rippening With Antiprogesterone in Midtrimester Abortions
Official Title
Cervical Rippening With Antiprogesterone in Midtrimester Abortions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
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.
Detailed Description
The aim of this study is to explore the effectiveness of Mifepristone for cervical ripening before high dose Oxytocin drip in midtrimester abortions. After informed consent, all the women will be randomized for Mifepristone or placebo. 48 hours later, high dose oxytocin drip will be started and we will examine the success rate to induce abortion, the duration from starting oxytocin till evacuation of uterus and side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Missed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pitocin
Arm Type
Experimental
Arm Description
Treatment with Pitocin after mifegine
Arm Title
Cytotec
Arm Type
Active Comparator
Arm Description
Treatment with cytotec after mifegine
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Primary Outcome Measure Information:
Title
success of abortion induction
Title
abortion induction duration
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
midtrimester late abortion
midtrimester induced abortion
Exclusion Criteria:
placenta previa
infected abortion
rupture of membranes
s/p cesarean section *2 or more
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assaf Ben-Meir, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Cervical Rippening With Antiprogesterone in Midtrimester Abortions
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