Cervical Preparation Before Dilation and Evacuation
- Conditions
- Abortion, Induced
- Interventions
- Registration Number
- NCT01751087
- Lead Sponsor
- Planned Parenthood League of Massachusetts
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Osmotic dilators + placebo (vit c) + placebo (vit B12) placebo Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators + placebo (vit c) + placebo (vit B12) Osmotic dilators Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2. Osmotic dilators + mifepristone + placebo (vit B12) Mifepristone Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Osmotic dilators + placebo (vit c) + misoprostol Osmotic dilators Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. Osmotic dilators + mifepristone + placebo (vit B12) placebo Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Osmotic dilators + placebo (vit c) + misoprostol placebo Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2. Osmotic dilators + mifepristone + placebo (vit B12) Osmotic dilators Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2. Osmotic dilators + placebo (vit c) + misoprostol misoprostol Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.
- Primary Outcome Measures
Name Time Method Operative Time participants were assessed for the duration of the procedure, an average of 6 minutes 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
Name Time Method Initial Cervical Dilation participants were assessed during cervical dilation process, average time of 1 minute Measured at the time of procedure (immediately before the start of D\&E)
Need for Mechanical Dilation participants were assessed for the duration of the procedure, an average of 6 minutes Assessed on Day of procedure. Assessed immediately after completion of D\&E
Ease of Mechanical Dilation participants were assessed for the duration of the procedure, an average of 6 minutes 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 assessed immediately after completion of D&E and at 1 week and 1 month post-procedure Patient having any complication, including hospitalizations transfusions additional unplanned procedures
Ability to Complete the D&E on the First Attempt participants were assessed for the duration of the procedure, an average of 6 minutes 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.
Chills (Any) After Day 2 Medication Administration assessed immediately after administration of day 2 medication chills (any) after Day 2 medication administration
Physician Satisfaction With Cervical Preparation physicians' satisfaction with cervical prep was evaluated over course of procedure, an average of 6 minutes 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.
Patient Satisfaction With Cervical Prep patients' satisfaction with cervical prep was evaluated over course of cervical prep and procedure, up to 3 days 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.
Trial Locations
- Locations (7)
Family Planning Associates
🇺🇸Chicago, Illinois, United States
Planned Parenthood of New York City
🇺🇸New York, New York, United States
Lovejoy Surgical Center
🇺🇸Portland, Oregon, United States
Magee Women's Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
San Francisco General Hospital
🇺🇸San Francisco, California, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States