OPIOID Study - Pain With Osmotic Dilators

NCT ID: NCT03710239

Last Updated: 2020-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-02

Study Completion Date

2020-03-11

Brief Summary

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

Detailed Description

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This is a randomized controlled trial to assess and compare pain levels and pain medication needs following placement of Laminaria versus Dilapan-S for cervical preparation prior to second-trimester dilation and evacuation (D\&E) procedures. Pain levels and medication usage will also be assessed following the D\&E procedure itself, up to 7 days after the procedure.

Conditions

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Abortion in Second Trimester

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants will not know what type of dilator they have been assigned, however the medical care team (including investigators) will be aware.

Study Groups

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Dilapan-S

Synthetic osmotic dilator

Group Type ACTIVE_COMPARATOR

Dilapan-S

Intervention Type DEVICE

Synthetic osmotic dilator

Laminaria

Seaweed-based osmotic dilator

Group Type ACTIVE_COMPARATOR

Laminaria

Intervention Type DEVICE

Seaweed-based osmotic dilator

Interventions

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Dilapan-S

Synthetic osmotic dilator

Intervention Type DEVICE

Laminaria

Seaweed-based osmotic dilator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Albany Medical College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Albany Medical Center Obstetrics and Gynecology

Albany, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5209

Identifier Type: -

Identifier Source: org_study_id

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