Cervical Preparation Before Dilation and Evacuation

Abortion, Induced Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751087
• Other study ID #: 9-500-25.1
• Secondary ID: SFPRF6-MS
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: January 27, 2016
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Planned Parenthood League of Massachusetts
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT01799928

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Other:
• Mifepristone
oral mifepristone 200 mg on Day 1.

Drug:
• misoprostol
buccal misoprostol 400 mcg on Day 2

Device:
• Osmotic dilators
osmotic dilators on Day 1

Other:
• placebo
placebo for mifepristone, on day 1
• placebo
placebo for misoprostol, on day 2

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Family Planning Associates	Chicago	Illinois
United States	Planned Parenthood of New York City	New York	New York
United States	Magee Women's Hospital	Pittsburgh	Pennsylvania
United States	Lovejoy Surgical Center	Portland	Oregon
United States	San Francisco General Hospital	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Planned Parenthood League of Massachusetts	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	Chills (Any) After Day 2 Medication Administration	chills (any) after Day 2 medication administration	assessed immediately after administration of day 2 medication	No
Secondary	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	No
Secondary	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	No