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Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial

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ClinicalTrials.gov Identifier: NCT02279914
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Planned Parenthood of New York City, Inc.

Brief Summary:

This study is a blinded randomized trial to compare two different doses and intervals of buccal misoprostol for cervical preparation before surgical abortion at 13 to 16 weeks' gestation: 400 mcg administered 3 hours before D&E (dilation and extraction), and 600 mcg administered 1.5 hours before D&E.

Primary objective: To compare operative times after two different doses and intervals of misoprostol using a non-inferiority design.

Secondary objectives: To compare the doses and intervals of misoprostol for differences in: (1) initial cervical dilation; (2) need for mechanical dilation and ease of dilation if required; (3) ability to complete the abortion procedure without further cervical preparation; (4) complications; (5) provider variables including ease of procedure and satisfaction with cervical preparation; (6) patient variables including pre-operative side effects, post-operative pain, and acceptability


Condition or disease Intervention/treatment Phase
Abortion, Induced Drug: Misoprostol 400 mcg 3 hours prior to procedure Drug: Misoprostol 600 mcg 90 minutes prior to procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Misoprostol Dose and Timing Before Surgical Abortion at 13 to 16 Weeks' Gestation: a Randomized Trial
Study Start Date : November 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: 400 mcg
receives 400 mcg of misoprostol 3 hours prior to the procedure
Drug: Misoprostol 400 mcg 3 hours prior to procedure
Experimental: 600 mcg
receives 600 mcg of misoprostol 90 minutes prior to the procedure
Drug: Misoprostol 600 mcg 90 minutes prior to procedure



Primary Outcome Measures :
  1. procedure time [ Time Frame: day of abortion procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • Eligible for pregnancy termination at Planned Parenthood of NYC
  • Able to give informed consent
  • English speaking

Exclusion Criteria:

  • Reports active bleeding, severe pain, or symptoms of spontaneous labor at enrollment
  • Intrauterine fetal demise identified on pre-operative ultrasound
  • Allergy to misoprostol

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): NCT02279914


Locations
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United States, New York
Planned Parenthood of New York City - Margaret Sanger Center
New York, New York, United States, 10012
Sponsors and Collaborators
Planned Parenthood of New York City, Inc.
Investigators
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Principal Investigator: Principal Investigator, MD, MPH Planned Parenthood of NYC

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Responsible Party: Planned Parenthood of New York City, Inc.
ClinicalTrials.gov Identifier: NCT02279914    
Other Study ID Numbers: Miso
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics