Skip to main content
OpenTrials
Completed

NCT Number: NCT05099991

Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abortion, Second Trimester

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single Foley Balloon

Device

Foley Balloon will be placed through the cervix and inflated with 30mL of saline or water on the day prior to the procedure

Dilapan-S

Device

Dilapan S will be placed through the cervix on the day prior to the procedure

Primary outcomes

  1. Procedure Time

    Time frame: Up to approximately 30 minutes

    Time to speculum in to speculum out

Secondary outcomes

  1. Cervical Dilation

    Time frame: Beginning of the procedure (approximately 5 seconds to assess)

    Measure the cervical dilation after removal of the Foley balloon or Dilapan-S

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2021
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.