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Misopristol Versus Pitocin for Second Trimester Abortion

Primary Purpose

Abortion, Missed

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
mifepristone and misopristol
mifepristone and oxytocin
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abortion, Missed

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Active Comparator

Active Comparator

Arm Label

pitocin

misopristol

Arm Description

high dose pitocin drip 48 hours after mifepristone preparation.

vaginal and oral misopristol 48 hours after mifepristone preparation.

Outcomes

Primary Outcome Measures

Success rate of abortion
Interval to abortion

Secondary Outcome Measures

Side effects

Full Information

First Posted
November 2, 2008
Last Updated
November 20, 2013
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00784797
Brief Title
Misopristol Versus Pitocin for Second Trimester Abortion
Official Title
Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

Brief Summary
Second trimester abortion can be done surgically or medically. Medical abortion with mifepristone and misopristol is one of the common protocol, but misopristol have high rate side effect. The investigators recent study proved the efficacy of pitocin after mifepristone in second trimester abortion with minimal side effects. Working hypothesis and aims: To compare misopristol and pitocin after mifepristone preparation in second trimester in seccess rate, interval to abortion, side effects and patient satisfaction.

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
Active Comparator
Arm Description
high dose pitocin drip 48 hours after mifepristone preparation.
Arm Title
misopristol
Arm Type
Active Comparator
Arm Description
vaginal and oral misopristol 48 hours after mifepristone preparation.
Intervention Type
Drug
Intervention Name(s)
mifepristone and misopristol
Intervention Description
200 mg mifepristone and after 48 hours vaginal misopristol 800 mgr followed by oral misopristol 400 mgr every 3 hours for maxamum 5 doses
Intervention Type
Drug
Intervention Name(s)
mifepristone and oxytocin
Intervention Description
200 mg mifepristone followed 48 hours with high dose oxytocin drip (9 unit per hour)
Primary Outcome Measure Information:
Title
Success rate of abortion
Time Frame
24 hours
Title
Interval to abortion
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 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

Citations:
PubMed Identifier
34061352
Citation
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
Results Reference
derived
PubMed Identifier
27539053
Citation
Freeman MD, Porat N, Rojansky N, Elami-Suzin M, Winograd O, Ben-Meir A. Physical symptoms and emotional responses among women undergoing induced abortion protocols during the second trimester. Int J Gynaecol Obstet. 2016 Nov;135(2):154-157. doi: 10.1016/j.ijgo.2016.05.008. Epub 2016 Aug 15.
Results Reference
derived
PubMed Identifier
24084539
Citation
Elami-Suzin M, Freeman MD, Porat N, Rojansky N, Laufer N, Ben-Meir A. Mifepristone followed by misoprostol or oxytocin for second-trimester abortion: a randomized controlled trial. Obstet Gynecol. 2013 Oct;122(4):815-820. doi: 10.1097/AOG.0b013e3182a2dcb7.
Results Reference
derived

Learn more about this trial

Misopristol Versus Pitocin for Second Trimester Abortion

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