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Trial record 36 of 59 for:    abortion , gynuity

Pain Control In First Trimester Medical Abortion: A Randomized Trial

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.
 
ClinicalTrials.gov Identifier: NCT01457521
Recruitment Status : Completed
First Posted : October 24, 2011
Results First Posted : January 13, 2016
Last Update Posted : January 13, 2016
Sponsor:
Collaborators:
Society of Family Planning
Family Planning Associates Medical Group, LTD
Planned Parenthood of New York City, Inc.
Information provided by (Responsible Party):
Gynuity Health Projects

Brief Summary:
This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain.

Condition or disease Intervention/treatment Phase
Pain Drug: Ibuprofen Phase 4

Detailed Description:
This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain. Secondary objectives include comparing the regimens for the total amount of ibuprofen taken, use of other analgesics, vaginal bleeding, adverse events, successful completion of abortion, overall satisfaction with the abortion procedure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PAIN CONTROL IN FIRST TRIMESTER MEDICAL ABORTION: A Randomized Trial
Study Start Date : October 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Therapeutic
Ibuprofen
Drug: Ibuprofen
Ibuprofen

Active Comparator: Prophylactic
Ibuprofen
Drug: Ibuprofen
Ibuprofen




Primary Outcome Measures :
  1. 11-point Visual Analog Scale for Pain [ Time Frame: 1-2 weeks ]
    Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with a gestational age of 63 days or less
  • Desire a medical abortion with mifepristone and misoprostol

Exclusion Criteria:

- Have contraindications to ibuprofen


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): NCT01457521


Locations
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United States, Illinois
Family Planning Associates Medical Group
Chicago, Illinois, United States, 60630
United States, New York
Planned Parenthood of New York City, Inc.
New York, New York, United States, 10012
Sponsors and Collaborators
Gynuity Health Projects
Society of Family Planning
Family Planning Associates Medical Group, LTD
Planned Parenthood of New York City, Inc.
Investigators
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Principal Investigator: Elizabeth Raymond, MD, MPH Gynuity Health Projects

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01457521     History of Changes
Other Study ID Numbers: 1000
First Posted: October 24, 2011    Key Record Dates
Results First Posted: January 13, 2016
Last Update Posted: January 13, 2016
Last Verified: October 2015
Keywords provided by Gynuity Health Projects:
pain
medical abortion
Additional relevant MeSH terms:
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Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action