Trials / Completed
CompletedNCT05099991
Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion
Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion: a Non-Inferiority Randomized Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Single Foley Balloon | Foley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure |
| DEVICE | Dilapan-S | Dilapan S will be placed through the cervix on the day prior to the procedure |
Timeline
- Start date
- 2022-02-08
- Primary completion
- 2023-04-27
- Completion
- 2023-04-28
- First posted
- 2021-10-29
- Last updated
- 2024-04-18
- Results posted
- 2024-04-18
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05099991. Inclusion in this directory is not an endorsement.