NCT02725710

Brief Summary

This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2018

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 2, 2019

Completed
Last Updated

July 2, 2019

Status Verified

June 1, 2019

Enrollment Period

1.9 years

First QC Date

March 2, 2016

Results QC Date

June 12, 2019

Last Update Submit

June 12, 2019

Conditions

Other AbortionSpontaneous Abortion

Keywords

uterine aspiration

Outcome Measures

Primary Outcomes (1)

  • Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure

    Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.

    5 minutes

Secondary Outcomes (11)

  • Pain Score on the 100-mm VAS

    Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute

  • Perioperative Nausea as Measured by 100-mm VAS

    Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

  • Number of Subjects Experiencing Perioperative Vomiting

    Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

  • Perioperative Anxiety as Measured by the 100-mm VAS

    5 minutes, 10 minutes, 30 minutes, discharge

  • Number of Subjects Using Pain Medications

    24 hours post-operatively

  • +6 more secondary outcomes

Study Arms (2)

Group 1: Placebo

ACTIVE COMPARATOR

Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.

Drug: Placebo

Group 2: Gabapentin

ACTIVE COMPARATOR

Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.

Drug: Gabapentin

Interventions

GabapentinDRUG

600mg Gabapentin administered orally 1-2 hours prior to procedure

Also known as: Neurontin
Group 2: Gabapentin
PlaceboDRUG

Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure

Also known as: sugar pill
Group 1: Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women \>=18 years-old
  • Presenting for a surgical abortion
  • No contraindication to outpatient abortion
  • No contraindication to gabapentin
  • Fluency in English and able to provide informed consent

You may not qualify if:

  • Allergy, sensitivity or contraindication to gabapentin
  • Severe renal disease
  • Currently using gabapentin or pregalabin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

Related Publications (1)

  • Gray BA, Hagey JM, Crabtree D, Wynn C, Weber JM, Pieper CF, Haddad LB. Gabapentin for Perioperative Pain Management for Uterine Aspiration: A Randomized Controlled Trial. Obstet Gynecol. 2019 Sep;134(3):611-619. doi: 10.1097/AOG.0000000000003398.

    PMID: 31403587DERIVED

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

GabapentinSugars

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Results Point of Contact

Title
Jeremy M. Weber
Organization
Duke University
jeremy.m.weber@duke.edu
919-681-4561

Study Officials

  • Beverly Gray, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

April 1, 2016

Study Start

August 1, 2016

Primary Completion

June 13, 2018

Study Completion

June 14, 2018

Last Updated

July 2, 2019

Results First Posted

July 2, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)