Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Study Overview
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Brief Summary
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In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.

Official Title
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Mifepristone Versus Osmotic Dilator Insertion for Cervical Preparation Prior to Surgical Abortion at 15-18 Weeks

Conditions
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Cervical Preparation

Intervention / Treatment
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* Drug: Mifepristone
* Device: osmotic dilators


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 18-50 years of age undergoing surgical termination of pregnancy English or Spanish speaking Gestational age between 15 and 18 weeks gestation on day of abortion (inclusive), by ultrasound dating Eligible for a dilation and evacuation abortion with local anesthesia and sedation Ultrasound for dating purposes done within the last two weeks Exclusion Criteria: Intrauterine infection Fetal demise Ruptured membranes Multiple gestation Uterine anomaly or significant distortion of the uterus with fibroids BMI greater than 45 Inability to place osmotic dilators Active substance abuse or intoxication Adrenal failure, chronic corticosteroid use, anticoagulant usage Severe cervicitis, until treated and resolved Prior Cesarean section

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mifepristone + misoprostol<br>Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure | Drug: Mifepristone<br>* 200 mg po 20-24 hours prior to the procedure<br>* Other names: Mifegyne;|
| Active Comparator: Osmotic dilators<br>Placed 20-24 hours prior to procedure | Device: osmotic dilators<br>* osmotic dilators placed in the cervix 20-24 hours prior to the procedure<br>* Other names: Dilapan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Procedure | Interval from speculum insertion to speculum removal | Subjects will be followed from the administration of mifepristone/misoprostol or laminaria, until the end of their procedure, a total of two days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Time | Interval from initiation of vacuum aspiration to speculum removal | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. | 
| Subject Discomfort Before the Abortion | Pain was subjectively described by the subjects as : None, Mild, Moderate, Severe | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. | 
| Pain Medication (Fentanyl) During the Abortion | Amount of pain medication used during the procedure: reported as micrograms of fentanyl | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. | 
| Pain Medication (Midazolam) During the Abortion | Amount of pain medication used during the procedure: reported as milligrams of midazolam | Subjects will be followed from the administration of mifepristone/misoprostol, or laminaria, until the end of their procedure, a total of two days. | 
| Cervical Dilation Achieved | Cervical dilation at start of procedure | At time of abortion | 
| Acceptability to Patient | Patient was asked whether they would choose to be in the same group again if they had a similar procedure again. The number of participants whose response was yes is being reported. | After procedure completion | 
| Difficulty of Procedure | Outcome measure is the number and percentage of participants where the provider rated the procedure as difficult or very difficult. Provider assessment of difficulty of procedure categories were: very easy, easy, moderate, difficult, or very difficult. | After completion of procedure |