Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

Study Overview
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Brief Summary
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This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.

Official Title
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Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services

Conditions
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Legally Induced Abortion Without Mention of Complication

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


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 24 wks 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Dilapan-Placebo<br>The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. | Other: Hygroscopic cervical dilators<br>* Dilapan-S osmotic cervical dilators inserted through the internal os.<br>* Other names: Dilapan-S;Drug: Misoprostol<br>* 400 mcg buccal misoprostol 90 pre-op<br>Drug: Intra-amniotic digoxin<br>* 1mg digoxin administered intra-amniotically  24 hours pre-op in patients that are greater than 22 weeks gestation<br>|
| Active Comparator: Dilapan-Mifepristone<br>The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. | Other: Hygroscopic cervical dilators<br>* Dilapan-S osmotic cervical dilators inserted through the internal os.<br>* Other names: Dilapan-S;Drug: Misoprostol<br>* 400 mcg buccal misoprostol 90 pre-op<br>Drug: Intra-amniotic digoxin<br>* 1mg digoxin administered intra-amniotically  24 hours pre-op in patients that are greater than 22 weeks gestation<br>Drug: Mifepristone<br>* 200 mcg Mifepristone orally<br>* Other names: Mifeprex;|
| Experimental: Mifepristone<br>The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure. | Drug: Misoprostol<br>* 400 mcg buccal misoprostol 90 pre-op<br>Drug: Intra-amniotic digoxin<br>* 1mg digoxin administered intra-amniotically  24 hours pre-op in patients that are greater than 22 weeks gestation<br>Drug: Mifepristone<br>* 200 mcg Mifepristone orally<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 Time, Collected immediately within procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Uterine perforation | 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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Cervical Preparation, Induced Abortion, Mifepristone, Dilation and Evacuation, Osmotic Dilators