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

This study has been terminated.
(Slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Boston University
ClinicalTrials.gov Identifier:
NCT01436266
First received: September 15, 2011
Last updated: March 18, 2014
Last verified: March 2014
  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:


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 ]

Enrollment: 2
Study Start Date: July 2011
Study Completion Date: August 2012
Primary Completion Date: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436266

Locations
United States, Massachusetts
Boston University
Boston, Massachusetts, United States, 02118
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: March 18, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014