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Misopristol Versus Pitocin for Second Trimester Abortion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00784797
First Posted: November 4, 2008
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assaf Ben Meir, Hadassah Medical Organization
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Misopristol and Pitocin After Mifepristone Preparation for Second Trimeter Abortion

Resource links provided by NLM:


Further study details as provided by Assaf Ben Meir, Hadassah Medical Organization:

Primary Outcome Measures:
  • Success rate of abortion [ Time Frame: 24 hours ]
  • Interval to abortion [ Time Frame: 24 hours ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 24 hours ]

Enrollment: 145
Study Start Date: January 2009
Study Completion Date: June 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784797


Locations
Israel
Hadassah Medical Organization
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Assaf Ben-Meir, MD Hadassah Medical Organization
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assaf Ben Meir, MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00784797     History of Changes
Other Study ID Numbers: PitocinPGMyf-HMO-CTIL
First Submitted: November 2, 2008
First Posted: November 4, 2008
Last Update Posted: November 21, 2013
Last Verified: November 2013

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