Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.

Official Title
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Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion: a Non-Inferiority Randomized Trial

Conditions
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Abortion, Second Trimester

Intervention / Treatment
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* Device: Single Foley Balloon
* Device: Dilapan-S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: presenting to clinic for second trimester abortion at 18 to 23 weeks and 6 days gestation confirmed by ultrasound able to provide informed consent and comply with study protocol English or Spanish-speaking candidate for outpatient cervical preparation Exclusion Criteria: Anyone with an allergy to misoprostol, mifepristone or any study medication premature rupture of membranes intrauterine fetal demise placenta previa suspected abnormal placentation evidence of infection at the time of enrollment

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Dilapan-S<br>A number of Dilapan-S will be inserted for cervical preparation. The number will be determined by a standard protocol that is based on gestational age. The dilators will stay in until the next day prior to their procedure, or earlier if they fall out on their own. | Device: Dilapan-S<br>* Dilapan S will be placed through the cervix on the day prior to the procedure<br>|
| Experimental: Foley balloon<br>A Foley balloon will be inserted for cervical preparation and filled to 30mL of water or saline. The balloon will stay in until the next day prior to their procedure, or earlier if it falls out on its own. | Device: Single Foley Balloon<br>* Foley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Time to speculum in to speculum out | Approximately 12 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical dilation | Measure the cervical dilation after removal of the Foley balloon or Dilapan-S | Beginning of the procedure (approximately 5 seconds to assess) |