Other AbortionPhase 2GABANCT02725710

Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration

A Phase 2 study testing Gabapentin in people with Other Abortion and Spontaneous Abortion, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Other Abortion, Spontaneous Abortion
What is being tested?: Gabapentin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteUnited States
Study dates: Aug 2016to 14 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27701

Other trials in United States

About this study

Official title: Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial

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.

Conditions: Other Abortion, Spontaneous Abortion
Being tested: Gabapentin, Placebo
Keywords: uterine aspiration
Medical subject headings: Abortion, Spontaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GabapentinDrug
Also called Neurontin
600mg Gabapentin administered orally 1-2 hours prior to procedure
PlaceboDrug
Also called sugar pill
Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure

Study groups in NCT02725710
Study group	Role	What they receive
Group 1: Placebo	Active comparator	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Receives: Drug: Placebo
Group 2: Gabapentin	Active comparator	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Receives: Drug: Gabapentin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 minutes

Secondary outcomes (11)

Pain Score on the 100-mm VAS
Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Measured: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute
Perioperative Nausea as Measured by 100-mm VAS
Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.
Measured: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Number of Subjects Experiencing Perioperative Vomiting
Measured: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Perioperative Anxiety as Measured by the 100-mm VAS
Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.
Measured: 5 minutes, 10 minutes, 30 minutes, discharge
Number of Subjects Using Pain Medications
Pain medications included ibuprofen and oxycodone.
Measured: 24 hours post-operatively
Number of Subjects Experiencing Side Effects
Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.
Measured: 10 minutes post-procedure
Pain (on a 5-point Scale)
Measured: Post-operative day 1
Nausea (on a 5-point Scale)
Measured: Post-operative day 1
Vomiting (on a 5-point Scale)
Measured: Post-operative day 1
Side Effects (on a 5-point Scale)
Measured: Post-operative day 1
General Satisfaction With the Procedure (on a 5-point Scale)
Measured: Post-operative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201614 Jun 2018

First posted1 Apr 2016 (estimated)
Study startAug 2016
Primary completion13 Jun 2018
Study completion14 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Other AbortionStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02725710
Sponsor's protocol ID: Pro00063872
Acronym: GABA
Status last verified: Jun 2019
First submitted: 2 Mar 2016
Last updated: 2 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 31403587

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02725710
Acronym / sponsor ID: GABA / Pro00063872
Conditions: Other Abortion, Spontaneous Abortion
Keywords: uterine aspiration
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Study start: Aug 2016
Primary completion: 13 Jun 2018 (actual)
Study completion: 14 Jun 2018 (actual)
First posted: 1 Apr 2016 (estimated)
Results: Posted 2 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Group 1: Placebo	Active comparator	Drug: PlaceboUsual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Group 2: Gabapentin	Active comparator	Drug: GabapentinUsual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GabapentinAlso: Neurontin600mg Gabapentin administered orally 1-2 hours prior to procedure	Drug	Group 2: Gabapentin
PlaceboAlso: sugar pillIdentical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Drug	Group 1: Placebo

Primary outcome

Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
Time frame: 5 minutes
Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.

11 secondary outcomes

Pain Score on the 100-mm VAS
Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute
Perioperative Nausea as Measured by 100-mm VAS
Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Number of Subjects Experiencing Perioperative Vomiting
Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Perioperative Anxiety as Measured by the 100-mm VAS
Time frame: 5 minutes, 10 minutes, 30 minutes, discharge
Number of Subjects Using Pain Medications
Time frame: 24 hours post-operatively
Number of Subjects Experiencing Side Effects
Time frame: 10 minutes post-procedure
Pain (on a 5-point Scale)
Time frame: Post-operative day 1
Nausea (on a 5-point Scale)
Time frame: Post-operative day 1
Vomiting (on a 5-point Scale)
Time frame: Post-operative day 1
Side Effects (on a 5-point Scale)
Time frame: Post-operative day 1
General Satisfaction With the Procedure (on a 5-point Scale)
Time frame: Post-operative day 1

Results and safety

Results posted to the registry on 2 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Placebo	48	47
Group 2: Gabapentin	47	47

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

Time frame: 5 minutes. Mean (Standard Deviation). Unit: score on a scale

Measure	Group 1: Placebo n = 48	Group 2: Gabapentin n = 47
Value	35.7 (27.5)	37.1 (30.4)

Group 1: Placebo vs Group 2: Gabapentin: p = 0.56, Regression, Linear

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 minutes post-procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Placebo	0 of 48 (0%)	40 of 48 (83.3%)	0 of 48
Group 2: Gabapentin	0 of 47 (0%)	43 of 47 (91.5%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31403587Gray 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Beverly Gray, MD principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gabapentin in people with Other Abortion and Spontaneous Abortion, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02725710, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.