Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

Study Overview
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Brief Summary
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Dilation and evacuation (D&E) is a common surgical procedure in the U.S. Adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. Traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. The objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for D&E.

Official Title
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Mifepristone Versus Osmotic Dilators in Conjunction With Misoprostol for Cervical Preparation Prior to D&E at 14-19 Weeks

Conditions
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Legally Induced Abortion Without Mention of Complication

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Mifepristone
* Device: Hygroscopic cervical dilators


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 Years Old Viable, Singleton pregnancy Voluntarily seeking abortion between 14-19 weeks gestation Able to give informed consent and comply with study protocol Fluent in English or Spanish Exclusion Criteria: Allergy to study drugs

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dilapan (14wks 0days-15wks, 6days)<br>The clinician will place 1 to 2 osmotic cervical dilators (Dilapan-S) (4mm x 65mm) the day before the participant's procedure. | Device: Hygroscopic cervical dilators<br>* osmotic cervical dilators inserted through the internal os<br>* Other names: Dilapan-S;|
| Active Comparator: Dilapan (16wks 0days-18wks, 6days)<br>The clinician will place 3 to 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. | Drug: Misoprostol<br>* 400 mcg buccal 60-90 minutes prior to procedure<br>* Other names: Cytotec;Device: Hygroscopic cervical dilators<br>* osmotic cervical dilators inserted through the internal os<br>* Other names: Dilapan-S;|
| Experimental: Mifepristone (14wks 0days-15wks, 6days)<br>The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. | Drug: Misoprostol<br>* 400 mcg buccal 60-90 minutes prior to procedure<br>* Other names: Cytotec;Drug: Mifepristone<br>* 200 mg PO on the day prior to D&E<br>* Other names: Mifeprex;|
| Experimental: Mifepristone (16wks 0days-18wks, 6days)<br>The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients in this arm will also receive 200 mg misoprostol PO 30-90 minutes prior to their procedure. | Drug: Misoprostol<br>* 400 mcg buccal 60-90 minutes prior to procedure<br>* Other names: Cytotec;Drug: Mifepristone<br>* 200 mg PO on the day prior to D&E<br>* Other names: Mifeprex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Time | Measured as time from speculum insertion to removal. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical Dilation | Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure | Baseline | 
| Total Procedure Time | All time required by patient (time in clinic for cervical preparation procedures) | Measured at clinic visit and on OR day, over 2 day period | 
| Difficulty of Procedure, as reported by clinician | Using Visual Analogue Scale (VAS) | Measured within 5 minutes after procedure | 
| Complications/Adverse Events | Estimated blood loss, uterine injury, infection, retained products of conception | Intraoperatively | 
| Pain Perceived by Patient | Using Visual Analogue Scale (VAS) | Intraoperatively Measured during dilator placement | 
| Overall Patient Experience | Using Visual Analogue Scale (VAS) | Measured post-operatively (30 minutes prior to discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induced Abortion, Mifepristone, Dilation and Evacuation, Cervical Preparation, Osmotic Dilators, Misoprostol