Cervical Ripening Balloons for Same-Day Cervical Prep

University of New Mexico70 enrolled

Overview

The goal of this clinical trial is to learn if a cervical ripening balloon (Foley balloon) works to prepare the cervix before same-day outpatient dilation and evacuation (D\&E). The main questions it aims to answer are: * Is cervical preparation with cervical ripening balloon for same-day outpatient D\&E non-inferior to cervical preparation with osmotic dilators? * How feasible and safe is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? * How acceptable is cervical preparation with cervical ripening balloon for same-day outpatient D\&E? Participants will: * Have cervical preparation with cervical ripening balloon (experimental group) or osmotic dilators (usual care group) * Complete two surveys, one about the cervical preparation and one about the D\&E procedure

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dilation and Evacuation

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals who desire outpatient dilation and evacuation (D\&E) * At least 18 years of age * Able and willing to consent * Gestational duration between 18 weeks 0 days and 19 weeks 6 days as determined by ultrasound * Able to read and understand English or Spanish * Able to obtain reliable post-procedure transportation * Able to observe fasting guidelines of 6 hours prior to the D\&E procedure Exclusion Criteria: * Medical conditions that require procedural management in the operating room * Preference for D\&E procedure in the operating room

Outcomes

Primary Outcomes

D&E procedure length (minutes)

From insertion of first instrument to removal of speculum

Time frame: during procedure

Secondary Outcomes

Starting dilation (French gauge)

Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)

Time frame: during procedure

Additional dilation (French gauge)

Pratt dilator size in French gauge (sequential numbered instruments with size corresponding to diameter)

Time frame: during procedure

Estimated blood loss (milliliters)

Amount of blood loss, measured in milliliters throughout the procedure

Time frame: during procedure

Additional sedation medication administered

yes/no

Time frame: during procedure

Pain (Visual Analog Scale)

10 point visual analog scale with values from 0-10, with 0 being "No pain" and 10 being "Worst possible pain." Electronic slider measure so participants can specify up to 0.001 value.

Time frame: during procedure

Administration of uterotonic medications

yes/no

Time frame: during procedure

Cervical laceration

yes/no

Time frame: during procedure

Estimated blood loss > 500 milliliters

yes/no