Value of Mifepristone in Cervical Preparation Prior to Dilation and Evacuation 19-24 Weeks

Study Overview
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Brief Summary
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A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased total time as two sets of dilators.

Official Title
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Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial

Conditions
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Abortion, Induced

Intervention / Treatment
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* Drug: Mifepristone
* Other: Hygroscopic cervical dilators
* Drug: Misoprostol
* Drug: Intra-amniotic digoxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >18 years old Viable, Singleton pregnancy Voluntarily seeking abortion between 19 and 24wks gestation Able to give informed consent and comply with study protocol Fluent in English or Spanish Exclusion Criteria: Allergy to misoprostol or mifepristone

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Two sets of dilators<br>Two sets of osmotic dilators inserted 1 and 2 days pre-op | Other: Hygroscopic cervical dilators<br>* Dilapan-S osmostic cervical dilators inserted through the internal os<br>* Other names: Dilapan-S;Drug: Misoprostol<br>* 400mcg buccal misoprostol 90 minutes pre-op<br>Drug: Intra-amniotic digoxin<br>* 1mg digoxin administered intra-amniotically  24 hours pre-op<br>|
| Experimental: Mifepristone plus one set of dilators<br>One set of dilators plus mifepristone | Drug: Mifepristone<br>* 200mg Mifepristone orally<br>* Other names: Danco, Mifeprex;Other: Hygroscopic cervical dilators<br>* Dilapan-S osmostic cervical dilators inserted through the internal os<br>* Other names: Dilapan-S;Drug: Misoprostol<br>* 400mcg buccal misoprostol 90 minutes pre-op<br>Drug: Intra-amniotic digoxin<br>* 1mg digoxin administered intra-amniotically  24 hours pre-op<br>|

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 Time | 
| Total Procedure Time |  | Measured at clinic visits and on OR day, over a 3 day period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Cervical Dilation | Measured by estimate with bimanual exam and passage of largest dilator immediately prior to procedure. | Measured intra-operatively | 
| Adverse Events (EBL) | One adverse event: Estimated Blood Loss | Intraoperatively | 
| Ease of Procedure by Blinded Surgeon | Used a Visual Analogue Scale to determine the ease of procedure by blinded surgeon. The VAS ranges from 0-100. 0 being the easiest procedure the surgeon felt they had every performed and 100 being the most difficult procedure imaginable by the surgeon. | Measured Immediately after procedure | 
| Pain Perceived by Patient | Used a Visual Analogue Scale to determine the pain perceived by the patient pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively). The VAS ranges from 0-100. 0 being no pain felt by the patient and 100 being the worst pain imaginable felt by the patient. | Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively) | 
| Overall Patient Experience | Used a Visual Analogue Scale to determine the patient's overall satisfaction with her experience. The VAS ranges from 0-100. 0 being a worse than expected experience, 50 being what the patient expected and 100 being a better than expected experience. | Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge | 
| Adverse Events | uterine perforation, uterine injury, etc. | Intraoperatively and 2 weeks post operatively | 

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