Dilapan Versus Laminaria

University of California, San Francisco72 enrolled

Overview

This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction. Hypothesis: Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference. Primary objective: Determine differences in procedure times Secondary objectives: Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cervical Preparation

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnancy between fourteen and eighteen weeks gestation * Request for elective abortion and certainty of decision to proceed Exclusion Criteria: * Incarceration * Minor status (women younger than eighteen years) * Allergy to Dilapan or laminaria * Inability to speak and understand Spanish or English

Outcomes

Primary Outcomes

Procedure Time

Procedure time to complete early second-trimester dilation and evacuation (D\&E)

Time frame: Day of procedure

Secondary Outcomes

Participants Who Experienced Complications or Need for Additional Dilation

Any complications, or mechanical dilation required, for early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria