Cervical Preparation Before Dilation and Evacuation

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT01751087
First received: December 12, 2012
Last updated: January 27, 2016
Last verified: January 2016
  Purpose

The purpose of this research study is to compare three different ways of opening a woman's cervix before her second-trimester surgical abortion.

  • Osmotic dilators: small rods that, when inserted into the cervix, gently expand to open the cervix
  • Osmotic dilators plus mifepristone, a medicine that is swallowed
  • Osmotic dilators plus misoprostol, a medicine that is placed between the cheek and gum

Hypotheses:

  • adding buccal misoprostol 3 hours preoperatively will significantly improve dilation compared to laminaria alone, making procedures faster, easier and safer.
  • adding oral mifepristone at the time of laminaria placement will confer a similar benefit.
  • the efficacy of adjunctive misoprostol and mifepristone will be influenced by gestational age, with women later in gestation having increased efficacy from these agents.
  • significantly more patients who receive adjunctive misoprostol or mifepristone will have adequate initial dilation, fewer will require manual dilation or additional cervical preparation and there will be fewer complications in these arms, although complication rates will be low and we will only be able to detect relatively large differences.
  • patients will prefer to have the procedure done as quickly as possible with as little discomfort as possible, that cervical ripening with adjunctive misoprostol will be associated with more cramping than osmotic dilators alone and that mifepristone will be well tolerated and may not cause more cramping or other side effects than osmotic dilators alone.

Condition Intervention
Abortion, Induced
Other: Mifepristone
Drug: misoprostol
Device: Osmotic dilators
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cervical Preparation Before Dilation and Evacuation in the Second Trimester: A Multicenter Randomized Trial Comparing Osmotic Dilators Alone to Dilators Plus Adjunctive Misoprostol or Adjunctive Mifepristone.

Resource links provided by NLM:


Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:
  • Operative Time [ Time Frame: participants were assessed for the duration of the procedure, an average of 6 minutes ] [ Designated as safety issue: No ]
    The duration of the D&E procedure was measured with a stopwatch, starting with the first instrument that passes into the uterus and ending when the last instrument is removed from the uterus upon completion of the D&E


Secondary Outcome Measures:
  • Initial Cervical Dilation [ Time Frame: participants were assessed during cervical dilation process, average time of 1 minute ] [ Designated as safety issue: No ]
    Measured at the time of procedure (immediately before the start of D&E)

  • Ability to Complete the D&E on the First Attempt [ Time Frame: participants were assessed for the duration of the procedure, an average of 6 minutes ] [ Designated as safety issue: No ]
    Assessed on day of procedure and following day. If the procedure was unable to be completed as planned and the subject had to leave the procedure room and return for another attempt either at a time later the same day or the next day.

  • Need for Mechanical Dilation [ Time Frame: participants were assessed for the duration of the procedure, an average of 6 minutes ] [ Designated as safety issue: No ]
    Assessed on Day of procedure. Assessed immediately after completion of D&E

  • Ease of Mechanical Dilation [ Time Frame: participants were assessed for the duration of the procedure, an average of 6 minutes ] [ Designated as safety issue: No ]
    Number of participants for whom, if additional mechanical dilation was required, it was difficult or very difficult. Assessed on day of procedure. Assessed after completion of D&E

  • Complications From Procedure [ Time Frame: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure ] [ Designated as safety issue: Yes ]
    Patient having any complication, including hospitalizations transfusions additional unplanned procedures

  • Chills (Any) After Day 2 Medication Administration [ Time Frame: assessed immediately after administration of day 2 medication ] [ Designated as safety issue: No ]
    chills (any) after Day 2 medication administration

  • Patient Satisfaction With Cervical Prep [ Time Frame: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days ] [ Designated as safety issue: No ]
    Patients who were very satisfied or satisfied with cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure and just prior to discharge home.

  • Physician Satisfaction With Cervical Preparation [ Time Frame: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes ] [ Designated as safety issue: No ]
    Participants for whom the operating physician reported being satisfied or very satisfied with the cervical preparation. Assessed on Day of procedure. Assessed after completion of D&E procedure.


Enrollment: 300
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Osmotic dilators + placebo (vit c) + placebo (vit B12)
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.
Device: Osmotic dilators
osmotic dilators on Day 1
Other Names:
  • laminaria
  • Dilapan-S
Other: placebo
placebo for mifepristone, on day 1
Other Name: vitamin C 500 mg
Other: placebo
placebo for misoprostol, on day 2
Other Name: vitamin B12 500 mcg
Active Comparator: Osmotic dilators + placebo (vit c) + misoprostol
Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
Drug: misoprostol
buccal misoprostol 400 mcg on Day 2
Other Name: Cytotec
Device: Osmotic dilators
osmotic dilators on Day 1
Other Names:
  • laminaria
  • Dilapan-S
Other: placebo
placebo for mifepristone, on day 1
Other Name: vitamin C 500 mg
Active Comparator: Osmotic dilators + mifepristone + placebo (vit B12)
Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.
Other: Mifepristone
oral mifepristone 200 mg on Day 1.
Other Name: Mifeprex
Device: Osmotic dilators
osmotic dilators on Day 1
Other Names:
  • laminaria
  • Dilapan-S
Other: placebo
placebo for misoprostol, on day 2
Other Name: vitamin B12 500 mcg

  Eligibility

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

Inclusion Criteria:

  • 18 years and older
  • Able to give informed consent
  • Medically eligible for outpatient second trimester pregnancy termination at the clinical site
  • English-speaking or Spanish-speaking at sites with ability to obtain informed consent in Spanish

Exclusion Criteria:

  • Active bleeding (>1 pad/hour) or hemodynamically unstable at enrollment
  • Signs of chorioamnionitis or clinical infection at enrollment
  • Signs of spontaneous labor or cervical insufficiency at enrollment
  • Spontaneous intrauterine fetal demise
  • Patient incarcerated
  • Allergy to mifepristone or misoprostol
  • Chronic steroid use or adrenal insufficiency
  • Porphyria
  • Inflammatory bowel disease requiring treatment
  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: NCT01751087

Locations
United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
United States, Illinois
Family Planning Associates
Chicago, Illinois, United States, 60630
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
Planned Parenthood of New York City
New York, New York, United States, 10012
United States, Oregon
Lovejoy Surgical Center
Portland, Oregon, United States, 97210
United States, Pennsylvania
Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Society of Family Planning
Investigators
Principal Investigator: Principal Investigator, MD, MPH Planned Parenthood League of Massachusetts
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT01751087     History of Changes
Obsolete Identifiers: NCT01799928
Other Study ID Numbers: 9-500-25.1  SFPRF6-MS 
Study First Received: December 12, 2012
Results First Received: September 2, 2015
Last Updated: January 27, 2016
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by Planned Parenthood League of Massachusetts:
abortion, induced

Additional relevant MeSH terms:
Vitamins
Vitamin B 12
Misoprostol
Mifepristone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Abortifacient Agents, Steroidal
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
Vitamin B Complex

ClinicalTrials.gov processed this record on July 21, 2016