Mifepristone Versus Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Study Overview
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Brief Summary
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Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.

Official Title
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Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks

Conditions
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Abortion

Intervention / Treatment
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* Drug: mifepristone 200 mg
* Device: osmotic dilator insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women aged 18-45 having pregnancy termination at 14-16 weeks Exclusion Criteria: multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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<br>women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed. | Drug: mifepristone 200 mg<br>* mifepristone would be given the day before the procedure<br>|
| Active Comparator: Osmotic dilator insertion<br>Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure | Device: osmotic dilator insertion<br>* osmotic dilators (3-6) would be inserted as usual the day before the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Completion of Procedure | Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal) | Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Ease of Procedure by Operator | The operator for each procedure rated the ease of procedure on a categorical scale. The categories were collapsed into two: easy or very easy and average or difficult. | It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point. | 
| Moderate or Severe Pain Overnight | Women wer asked to rank their amount of pain on a catergorical scale. The outcome measure is the number of women experiencing moderate or severe pain overnight (after mifepristone or osmotic dilators, and before the abortions procedure) | Overnight | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Length of time for procedure to be completed, Need for additional dilation, Subject satisfaction with procedure