Cervical Preparation Before Dilation and Evacuation

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.

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.

Study Overview

• Status: Completed
• Conditions: Abortion, Induced
• Intervention / Treatment: Device: Osmotic dilators; Other: placebo; Other: placebo; Drug: misoprostol; Other: Mifepristone

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • San Francisco General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60630
      • Family Planning Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • New York
    • New York, New York, United States, 10012
      • Planned Parenthood of New York City
  • Oregon
    • Portland, Oregon, United States, 97210
      • Lovejoy Surgical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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: Dilapan-S; laminaria; Other: placebo; placebo for mifepristone, on day 1; Other Names: vitamin C 500 mg; Other: placebo; placebo for misoprostol, on day 2; Other Names: 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.	Device: Osmotic dilators; osmotic dilators on Day 1; Other Names: Dilapan-S; laminaria; Other: placebo; placebo for mifepristone, on day 1; Other Names: vitamin C 500 mg; Other: placebo; placebo for misoprostol, on day 2; Other Names: vitamin B12 500 mcg; Drug: misoprostol; buccal misoprostol 400 mcg on Day 2; Other Names: Cytotec
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.	Device: Osmotic dilators; osmotic dilators on Day 1; Other Names: Dilapan-S; laminaria; Other: placebo; placebo for mifepristone, on day 1; Other Names: vitamin C 500 mg; Other: placebo; placebo for misoprostol, on day 2; Other Names: vitamin B12 500 mcg; Other: Mifepristone; oral mifepristone 200 mg on Day 1.; Other Names: Mifeprex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	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	participants were assessed for the duration of the procedure, an average of 6 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial Cervical Dilation	Measured at the time of procedure (immediately before the start of D&E)	participants were assessed during cervical dilation process, average time of 1 minute
Ability to Complete the D&E on the First Attempt	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.	participants were assessed for the duration of the procedure, an average of 6 minutes
Need for Mechanical Dilation	Assessed on Day of procedure. Assessed immediately after completion of D&E	participants were assessed for the duration of the procedure, an average of 6 minutes
Ease of Mechanical Dilation	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	participants were assessed for the duration of the procedure, an average of 6 minutes
Complications From Procedure	Patient having any complication, including hospitalizations transfusions additional unplanned procedures	assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
Chills (Any) After Day 2 Medication Administration	chills (any) after Day 2 medication administration	assessed immediately after administration of day 2 medication
Patient Satisfaction With Cervical Prep	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.	patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
Physician Satisfaction With Cervical Preparation	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.	physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes

Collaborators and Investigators

• Sponsor: Planned Parenthood League of Massachusetts
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Principal Investigator, MD, MPH, Planned Parenthood League of Massachusetts

Publications and helpful links

General Publications

• Goldberg AB, Fortin JA, Drey EA, Dean G, Lichtenberg ES, Bednarek PH, Chen BA, Dutton C, McKetta S, Maurer R, Winikoff B, Fitzmaurice GM. Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial. Obstet Gynecol. 2015 Sep;126(3):599-609. doi: 10.1097/AOG.0000000000000977.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: abortion, induced
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Micronutrients; Hormone Antagonists; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral; Contraceptive Agents, Female; Anti-Ulcer Agents; Contraceptives, Oral, Synthetic; Vitamin B Complex; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Luteolytic Agents; Abortifacient Agents, Steroidal; Contraceptives, Postcoital, Synthetic; Contraceptives, Postcoital; Menstruation-Inducing Agents; Vitamins; Misoprostol; Mifepristone; Vitamin B 12
• Other Study ID Numbers: 9-500-25.1; SFPRF6-MS (Other Grant/Funding Number: Society for Family Planning Research Fund)