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Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion (Preop Miso)

This study is currently recruiting participants.
Verified October 2011 by Boston University
Sponsor:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01436266
First received: September 15, 2011
Last updated: October 13, 2011
Last verified: October 2011
History of Changes
  Purpose

Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to aid in softening the cervix as well as decreasing blood loss after abortion or vaginal delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester surgical abortion decreases blood loss from the procedure. The investigators will also assess whether misoprostol improves cervical dilation, changes the length of the procedure, changes the need for additional mechanical dilation, changes the subjective ease of the procedure, and changes a woman's pain.


Condition Intervention Phase
Abortion
Blood Loss
 Drug: Misoprostol
Drug: Folic acid
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by Boston University:

Primary Outcome Measures:
  • Blood loss [ Time Frame: Subjects will be followed for the duration of their procedure visit, lasting one day. ] [ Designated as safety issue: Yes ]
    Measured blood loss


Secondary Outcome Measures:
  • Cervical dilation [ Time Frame: Subjects will be followed for the duration of their procedure visit, lasting one day. ] [ Designated as safety issue: Yes ]
  • Length of the procedure [ Time Frame: Subjects will be followed for the duration of their procedure visit, lasting one day. ] [ Designated as safety issue: No ]
  • Need for additional mechanical dilation [ Time Frame: Subjects will be followed for the duration of their procedure visit, lasting one day. ] [ Designated as safety issue: Yes ]
  • Subjective provider ease of procedure [ Time Frame: Subjects will be followed for the duration of their procedure visit, lasting one day. ] [ Designated as safety issue: No ]
  • Subject pain before the procedure [ Time Frame: Subjects will be followed for the duration of their procedure visit, lasting one day. ] [ Designated as safety issue: No ]
  • Subject pain during the procedure [ Time Frame: Subjects will be followed for the duration of their procedure visit, lasting one day. ] [ Designated as safety issue: No ]

Estimated Enrollment: 64
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol
400 mcg buccally 2 hours prior to procedure
 Drug: Misoprostol
200 mcg buccally prior to procedure
Other Name: Cytotec
Placebo Comparator: Placebo (Folic acid)
Two 1-mg tablets buccally 2 hours prior to procedure
 Drug: Folic acid
2mg buccally 2 hours prior to procedure

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English or Spanish speaking
  • Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound dating on the day of enrollment
  • Ultrasound used for dating purposes must be within the last two weeks.
  • Women 18-50 years of age undergoing surgical termination of pregnancy

Exclusion Criteria:

  • Spontaneous fetal demise
  • Ruptured membranes or intrauterine infection
  • Fibroids that significantly distort the uterine shape
  • Uterine abnormality such as unicornuate uterus
  • Prior transmural myomectomy
  • Severe oligohydramnios
  • Morbid obesity with BMI>45
  • Inability to place osmotic dilators
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436266

Contacts
Contact: Principal Investigator 617-414-7310 fpresearch@bmc.org

Locations
United States, Massachusetts
Boston University Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Principal Investigator            
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Principal Investigator Boston University
  More Information

No publications provided

Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT01436266     History of Changes
Other Study ID Numbers: H-30452
Study First Received: September 15, 2011
Last Updated: October 13, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Folic Acid
Vitamin B Complex
Misoprostol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
 Hematinics
Hematologic Agents
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 23, 2013