Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

Stanford University

Status: Completed

Conditions: Abortion, Second Trimester

Treatments: Device: Single Foley Balloon; Device: Dilapan-S

Study type: Interventional

Funder types: Other

Identifiers

NCT05099991

IRB-63172

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups, including a placebo group

Dilapan-S

Placebo Comparator group

Description:

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.

Treatment:

Device: Dilapan-S

Foley balloon

Experimental group

Description:

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.

Treatment:

Device: Single Foley Balloon