Clinical trial NCT01751087: Cervical Preparation Before Dilation and Evacuation
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion, Induced
Keywords: abortion, induced
Lead sponsor: Planned Parenthood League of Massachusetts
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2012-12-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Operative Time
timeFrame: participants were assessed for the duration of the procedure, an average of 6 minutes
Secondary outcomes:
measure: Initial Cervical Dilation
timeFrame: participants were assessed during cervical dilation process, average time of 1 minute
measure: Ability to Complete the D&E on the First Attempt
timeFrame: participants were assessed for the duration of the procedure, an average of 6 minutes
measure: Need for Mechanical Dilation
timeFrame: participants were assessed for the duration of the procedure, an average of 6 minutes
measure: Ease of Mechanical Dilation
timeFrame: participants were assessed for the duration of the procedure, an average of 6 minutes
measure: Complications From Procedure
timeFrame: assessed immediately after completion of D&E and at 1 week and 1 month post-procedure
measure: Chills (Any) After Day 2 Medication Administration
timeFrame: assessed immediately after administration of day 2 medication
measure: Patient Satisfaction With Cervical Prep
timeFrame: patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days
measure: Physician Satisfaction With Cervical Preparation
timeFrame: physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: Chicago
country: United States
facility: Family Planning Associates
state: Illinois
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: Planned Parenthood of New York City
state: New York
city: Portland
country: United States
facility: Lovejoy Surgical Center
state: Oregon
city: Pittsburgh
country: United States
facility: Magee Women's Hospital
state: Pennsylvania
Study officials:
affiliation: Planned Parenthood League of Massachusetts
name: Principal Investigator, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.