Abortion, InducedPhase 4GABANCT03080493
Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
A Phase 4 study testing Gabapentin 600mg and acetaminophen/codeine and ibuprofen in people with Abortion, Induced and Cervical Preparation, run by University of California, Davis at 1 site in United States.
Trial summary
Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age on the day of their procedure commonly have dilators placed in their cervix overnight before the abortion procedure. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Abortion, Induced, Cervical Preparation, Pain
- What is being tested?
- Gabapentin 600mg and acetaminophen/codeine and ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 5 Nov 2018
- Phase
- Phase 4
- 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
- 15 weeks 0 days gestational age - 23 weeks 5 days gestational age at time of dilator insertion
- Able to read and write in English
- Active cell phone with text messaging capability
- Ride home from dilator insertion clinic appointment
Who cannot join
- Current use of gabapentin or pregabalin
- Allergy to gabapentin, acetaminophen, codeine, or ibuprofen
- Self reported renal disease (severe impaired renal function)
- Self reported current or chronic narcotic use (typical daily use)
- Women with any issue that, in the opinion of the investigator, would interfere with study participation or generating accurate study data
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Davis Health System
Sacramento, California, 95817
About this study
Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age on the day of their procedure commonly have dilators placed in their cervix overnight before the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after women go home they expand slowly overnight to open the cervix before the abortion procedure the next day. This can be a painful experience and health care providers often give women different kinds of pain medicine to help them.
The investigators are interested in whether a medicine called gabapentin, which is a non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are also using it to decrease pain for people having surgical procedures.
Read more
The main goals of our study are to learn about:
- Women's pain experience with dilators in their cervix overnight before the abortion procedure
- How well gabapentin works to decrease women's pain while they have the dilators in their cervix
Women who enroll in the study will get a dose of either gabapentin or placebo (a pill with no medicine in it) before their dilators are placed in the clinic. The medication they get (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in the study nor the doctors giving them the medication will know which medication they receive so the investigators can learn about their pain without being influenced by knowing which medication they take. Doctors will be able to find out which medication women got if there is an emergency or if it changes their medical care.
The investigators will communicate with women in real time overnight by text messaging to see how much pain they are having in the moment and how much pain medicine they are taking.
The investigators hypothesize that women who receive gabapentin will have a smaller increase in their pain with the dilators than women who receive placebo (a pill with no medicine in it).
The investigators' findings will help doctors understand women's pain experience with dilators better and possibly provide a new way of treating pain with gabapentin.
Read the detailed description
The investigators have planned a double-blind randomized controlled trial of repeated doses of gabapentin compared to placebo for pain management during the time after dilator insertion and prior to D\&E the subsequent day.
- Participants will receive gabapentin 600 mg or placebo prior to dilator insertion
- Pain scores will be measured via numeric rating scale (NRS) at baseline and 5 minutes after last dilator insertion while the participant is in clinic
- Additional pain scores, side effects (specifically dizziness and sedation), and additional analgesic use will be obtained by text message while the patient is home at 2 hours, 4 hours, and 8 hours after time of dilator insertion
- Subjects will take a second dose of study drug (either gabapentin 600 mg or placebo, concordant with their initial medication) at 8 hours after their first dose
- Final pain score, side effect, and analgesic use assessment will occur upon presentation to the pre-operative are for D\&E the subsequent day
There will be no change in standard insertion of osmotic dilators (hygroscopic dilators only with Lidocaine 20mL cervical anesthesia), or provision of home analgesic medications (ibuprofen and acetaminophen with codeine in our practice).
The investigators hypothesize that women who receive gabapentin will report a smaller increase in pain from baseline at 8 hours after dilator placement compared to women receiving placebo.
- Conditions
- Abortion, Induced, Cervical Preparation, Pain
- Being tested
- Gabapentin 600mg, Placebo oral capsule, acetaminophen/codeine and ibuprofen
- Keywords
- Abortion, Osmotic dilators, Gabapentin, Text message
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 600mgDrug
Also called Neurontin
Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
Placebo oral capsuleDrug
Also called Carboxymethyl cellulose
Packaged identical to gabapentin dosing
acetaminophen/codeine and ibuprofenDrug
Also called Tylenol-Codeine No. 3, Advil
Over the counter analgesic medications
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Gabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home)
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight Receives: Drug: Gabapentin 600mg; Drug: acetaminophen/codeine and ibuprofen |
| Placebo oral capsule | Placebo comparator | Matched placebo
Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight Receives: Drug: Placebo oral capsule; Drug: acetaminophen/codeine and ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion
Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.
Measured: 8 hours after insertion of last osmotic dilator
Secondary outcomes (5)
Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion
Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person before subject leaves clinic appointment.
Measured: 5 minutes after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion
Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.
Measured: 2 hours after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion
Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.
Measured: 4 hours after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)
Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained in person upon presentation for D\&E procedure.
Measured: Time of presentation for D&E (day after dilator insertion)
Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)
Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion)
Measured: Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start20 Mar 2017
- Primary completion5 Nov 2018
- Study completion5 Nov 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 (3)Papers the sponsor has linked to this study.
- Other trials for Abortion, InducedStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized placebo controlled trial, stratified block randomization based on prior vaginal parity (vaginal parity - yes or no). Goal of even distribution of prior vaginal parity between gabapentin and placebo groups as may impact osmotic dilator pain experience
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Sponsor
- Investigators
- Natasha Schimmoeller, MD, MPH, MA, Principal investigator, University of California, DavisMitchell Creinin, MD, Study director, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080493
- Sponsor's protocol ID
- 987072
- Acronym
- GABA
- Status last verified
- Apr 2020
- First submitted
- 9 Mar 2017
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yan PZ, Butler PM, Kurowski D, Perloff MD. Beyond neuropathic pain: gabapentin use in cancer pain and perioperative pain. Clin J Pain. 2014 Jul;30(7):613-29. doi: 10.1097/AJP.0000000000000014.
PubMed 24281281Rose MA, Kam PC. Gabapentin: pharmacology and its use in pain management. Anaesthesia. 2002 May;57(5):451-62. doi: 10.1046/j.0003-2409.2001.02399.x.
PubMed 11966555Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.
PubMed 25139724
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03080493
- Acronym / sponsor ID
- GABA / 987072
- Conditions
- Abortion, Induced, Cervical Preparation, Pain
- Keywords
- Abortion, Osmotic dilators, Gabapentin, Text message
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 5 Nov 2018 (actual)
- Study completion
- 5 Nov 2018 (actual)
- First posted
- 15 Mar 2017 (actual)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women having abortion procedures between 15 weeks 0 days and 23 weeks 6 days gestational age on the day of their procedure commonly have dilators placed in their cervix overnight before the abortion procedure. The dilators are put in during a pelvic exam in the clinic and after women go home they expand slowly overnight to open the cervix before the abortion procedure the next day. This can be a painful experience and health care providers often give women different kinds of pain medicine to help them.
The investigators are interested in whether a medicine called gabapentin, which is a non-narcotic medicine, could help. Gabapentin is approved by the U.S. Food and Drug Administration (FDA) for prevention of seizures and for treating nerve pain and doctors are also using it to decrease pain for people having surgical procedures.
The main goals of our study are to learn about:
- Women's pain experience with dilators in their cervix overnight before the abortion procedure
- How well gabapentin works to decrease women's pain while they have the dilators in their cervix
Women who enroll in the study will get a dose of either gabapentin or placebo (a pill with no medicine in it) before their dilators are placed in the clinic. The medication they get (gabapentin or placebo) will be chosen by chance, like flipping a coin. Neither the women in the study nor the doctors giving them the medication will know which medication they receive so the investigators can learn about their pain without being influenced by knowing which medication they take. Doctors will be able to find out which medication women got if there is an emergency or if it changes their medical care.
The investigators will communicate with women in real time overnight by text messaging to see how much pain they are having in the moment and how much pain medicine they are taking.
The investigators hypothesize that women who receive gabapentin will have a smaller increase in their pain with the dilators than women who receive placebo (a pill with no medicine in it).
The investigators' findings will help doctors understand women's pain experience with dilators better and possibly provide a new way of treating pain with gabapentin.
Detailed description
The investigators have planned a double-blind randomized controlled trial of repeated doses of gabapentin compared to placebo for pain management during the time after dilator insertion and prior to D\&E the subsequent day.
- Participants will receive gabapentin 600 mg or placebo prior to dilator insertion
- Pain scores will be measured via numeric rating scale (NRS) at baseline and 5 minutes after last dilator insertion while the participant is in clinic
- Additional pain scores, side effects (specifically dizziness and sedation), and additional analgesic use will be obtained by text message while the patient is home at 2 hours, 4 hours, and 8 hours after time of dilator insertion
- Subjects will take a second dose of study drug (either gabapentin 600 mg or placebo, concordant with their initial medication) at 8 hours after their first dose
- Final pain score, side effect, and analgesic use assessment will occur upon presentation to the pre-operative are for D\&E the subsequent day
There will be no change in standard insertion of osmotic dilators (hygroscopic dilators only with Lidocaine 20mL cervical anesthesia), or provision of home analgesic medications (ibuprofen and acetaminophen with codeine in our practice).
The investigators hypothesize that women who receive gabapentin will report a smaller increase in pain from baseline at 8 hours after dilator placement compared to women receiving placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized placebo controlled trial, stratified block randomization based on prior vaginal parity (vaginal parity - yes or no). Goal of even distribution of prior vaginal parity between gabapentin and placebo groups as may impact osmotic dilator pain experience
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: Gabapentin 600mg, Drug: acetaminophen/codeine and ibuprofenGabapentin 600 mg PO - first dose in clinic prior to osmotic dilator placement, second dose 8 hours later (at home) Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsule, Drug: acetaminophen/codeine and ibuprofenMatched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 15 weeks 0 days gestational age - 23 weeks 5 days gestational age at time of dilator insertion
- Able to read and write in English
- Active cell phone with text messaging capability
- Ride home from dilator insertion clinic appointment
Key exclusion criteria (5 listed)
- Current use of gabapentin or pregabalin
- Allergy to gabapentin, acetaminophen, codeine, or ibuprofen
- Self reported renal disease (severe impaired renal function)
- Self reported current or chronic narcotic use (typical daily use)
- Women with any issue that, in the opinion of the investigator, would interfere with study participation or generating accurate study data
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 |
|---|---|---|
| Gabapentin 600mgAlso: NeurontinGabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place) | Drug | Gabapentin |
| Placebo oral capsuleAlso: Carboxymethyl cellulosePackaged identical to gabapentin dosing | Drug | Placebo oral capsule |
| acetaminophen/codeine and ibuprofenAlso: Tylenol-Codeine No. 3, AdvilOver the counter analgesic medications | Drug | Gabapentin, Placebo oral capsule |
Primary outcome
Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion
Time frame: 8 hours after insertion of last osmotic dilator
Pain score based on numeric rating scale (NRS [0 lowest value to 10 highest value, in which 0 is the lowest amount of pain and 10 is the highest amount of pain]); Baseline obtained prior to study drug ingestion/dilator insertion. NRS pain score obtained via text message.
5 secondary outcomes
Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion
Time frame: 5 minutes after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion
Time frame: 2 hours after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion
Time frame: 4 hours after insertion of last osmotic dilator
Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion)
Time frame: Time of presentation for D&E (day after dilator insertion)
Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine)
Time frame: Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24281281Yan PZ, Butler PM, Kurowski D, Perloff MD. Beyond neuropathic pain: gabapentin use in cancer pain and perioperative pain. Clin J Pain. 2014 Jul;30(7):613-29. doi: 10.1097/AJP.0000000000000014.
- Background: PubMed 11966555Rose MA, Kam PC. Gabapentin: pharmacology and its use in pain management. Anaesthesia. 2002 May;57(5):451-62. doi: 10.1046/j.0003-2409.2001.02399.x.
- Background: PubMed 25139724Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.
- Individual participant dataSharing planned: No
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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.
Natasha Schimmoeller, MD, MPH, MA principal investigator
University of California, Davis
Mitchell Creinin, MD study director
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin 600mg and acetaminophen/codeine and ibuprofen in people with Abortion, Induced and Cervical Preparation, run by University of California, Davis 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 4 inclusion and 5 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 14 Apr 2020. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 14 Apr 2020). 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?
Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion (time frame: 8 hours after insertion of last osmotic dilator). 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 NCT03080493, which also lists 3 linked publications.
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 14 Apr 2020.