OPIOID Study - Pain With Osmotic Dilators

NCT03710239 | Completed FDA Device

• 1 other identifier: 5209
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of pain levels and pain medications utilized following insertion of two different types of osmotic dilators.

Conditions

Abortion in Second Trimester

Outcome Measures

Primary Outcomes (2)

• Maximum pain above baseline following Laminaria versus Dilapan-S placement

  Timed surveys measuring pain on Numeric Rating Scale (0-10), administered approximately 24 hours after dilator placement

  First 24 hours after dilator placement

• Time of maximum pain above baseline following Laminaria versus Dilapan-S placement

  Timing of maximum Numeric Rating Scale (0-10) pain difference among measurements approximately 24 hours after dilator placement

  First 24 hours after dilator placement

Secondary Outcomes (3)

• Pain medication use after Laminaria versus Dilapan-S placement

  First 24 hours after dilator placement

• Maximum pain increase over baseline following D&E procedure

  First week after D&E

• Pain medication use after D&E

  First week after D&E

Study Arms (2)

Dilapan-S

ACTIVE COMPARATOR

Synthetic osmotic dilator

Device: Dilapan-S

Laminaria

ACTIVE COMPARATOR

Seaweed-based osmotic dilator

Device: Laminaria

Interventions

Dilapan-S DEVICE

Synthetic osmotic dilator

Dilapan-S

Laminaria DEVICE

Seaweed-based osmotic dilator

Laminaria

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled D\&E for 15+0 to 23+6 wga
• ability to speak and read in English
• ownership of smartphone with internet access and data plan

You may not qualify if:

• \- chronic pain, fibromyalgia, active pelvic infection, inability to take NSAIDS, current use of narcotics

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center Obstetrics and Gynecology

Albany, New York, 12208, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know what type of dilator they have been assigned, however the medical care team (including investigators) will be aware.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to receive one of two existing dilator times, with the remainder of care and study procedures being identical.

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 18, 2018
• Study Start: October 2, 2018
• Primary Completion: March 11, 2020
• Study Completion: March 11, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)