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Misopristol Versus Pitocin for Second Trimester Abortion

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00784797
First received: November 2, 2008
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Abortion, Missed
 Drug: mifepristone and misopristol
Drug: mifepristone and oxytocin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Success rate of abortion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Interval to abortion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pitocin
high dose pitocin drip 48 hours after mifepristone preparation.
 Drug: mifepristone and oxytocin
200 mg mifepristone followed 48 hours with high dose oxytocin drip (9 unit per hour)
Active Comparator: misopristol
vaginal and oral misopristol 48 hours after mifepristone preparation.
 Drug: mifepristone and misopristol
200 mg mifepristone and after 48 hours vaginal misopristol 800 mgr followed by oral misopristol 400 mgr every 3 hours for maxamum 5 doses

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784797

Contacts
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD     00 972 2 6776095     arik@hadassah.org.il    
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    
Principal Investigator: Assaf Ben-Meir, MD            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Assaf Ben-Meir, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Arik Tzukert, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT00784797     History of Changes
Other Study ID Numbers: PitocinPGMyf-HMO-CTIL
Study First Received: November 2, 2008
Last Updated: June 22, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Abortion, Missed
Abortion, Spontaneous
Pregnancy Complications
Mifepristone
Oxytocin
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Oxytocics

ClinicalTrials.gov processed this record on June 18, 2013