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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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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 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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo oral capsule | Placebo Comparator | Matched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin 600mg | Drug | Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 hours after insertion of last osmotic dilator |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 minutes after insertion of last osmotic dilator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Natasha Schimmoeller, MD, MPH, MA | University of California, Davis | Principal Investigator |
| Mitchell Creinin, MD | University of California, Davis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis Health System | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24281281 | Background | 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. | |
| 11966555 | Background | Rose 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin | 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 Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place) acetaminophen/codeine and ibuprofen: Over the counter analgesic medications |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 11, 2018 |
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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
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| Placebo oral capsule | Drug | Packaged identical to gabapentin dosing |
|
|
| acetaminophen/codeine and ibuprofen | Drug | Over the counter analgesic medications |
|
|
| 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. | 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. | 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. | 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) | Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure) |
| 25139724 | Background | Mercier 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. |
| FG001 | Placebo Oral Capsule | Matched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight Placebo oral capsule: Packaged identical to gabapentin dosing acetaminophen/codeine and ibuprofen: Over the counter analgesic medications |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin | 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 Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place) acetaminophen/codeine and ibuprofen: Over the counter analgesic medications |
| BG001 | Placebo Oral Capsule | Matched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight Placebo oral capsule: Packaged identical to gabapentin dosing acetaminophen/codeine and ibuprofen: Over the counter analgesic medications |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Reasons for abortion | Count of Participants | Participants |
| ||||||||||||||||
| Education | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Women who responded with pain scores by text using Numeric Rating Scale | Posted | Median | Full Range | Numeric rating scale pain score change | 8 hours after insertion of last osmotic dilator |
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| Secondary | 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. | Women who provided Numeric rating scale pain score | Posted | Median | Full Range | Numeric rating scale pain score change | 5 minutes after insertion of last osmotic dilator |
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| Secondary | 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. | Women who responded by text with numeric pain scale score | Posted | Median | Full Range | Numeric rating scale pain score change | 2 hours after insertion of last osmotic dilator |
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| Secondary | 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. | Women who responded by text with numeric pain scale score | Posted | Mean | Full Range | Numeric rating scale pain score change | 4 hours after insertion of last osmotic dilator |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Women who provided numeric pain scale scores | Posted | Median | Full Range | Numeric rating scale pain score change | Time of presentation for D&E (day after dilator insertion) |
| ||||||||||||||||||||||||||||||
| Secondary | 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) | Any use of narcotics | Posted | Count of Participants | Participants | Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure) |
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One day (from treatment initiation until procedure the following day
Only adverse events collected were specific to the intervention: dizziness and tiredness
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin | 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 Gabapentin 600mg: Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place) acetaminophen/codeine and ibuprofen: Over the counter analgesic medications | 0 | 60 | 0 | 60 | 57 | 60 |
| EG001 | Placebo Oral Capsule | Matched placebo Will receive standard regimen of acetaminophen/codeine and ibuprofen to take as needed for pain overnight Placebo oral capsule: Packaged identical to gabapentin dosing acetaminophen/codeine and ibuprofen: Over the counter analgesic medications | 0 | 58 | 0 | 58 | 51 | 58 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness at baseline | Nervous system disorders | Non-systematic Assessment | Dizziness |
| |
| Dizziness at 5 minutes after dilator placement | Nervous system disorders | Non-systematic Assessment | Dizziness |
| |
| Dizzines at 2 hours after dilator placement | Nervous system disorders | Non-systematic Assessment | Dizziness |
| |
| Dizziness at 4 hours after dilator placement | Nervous system disorders | Non-systematic Assessment | Dizziness |
| |
| Dizziness at 8 hours after dilator placement | Nervous system disorders | Non-systematic Assessment | Dizziness |
| |
| Dizziness at 18-24 hours after dilator placement | Nervous system disorders | Non-systematic Assessment | Dizziness |
| |
| Tiredness at baseline | General disorders | Non-systematic Assessment | Tiredness |
| |
| Tiredness at 5 minutes after dilator placement | General disorders | Non-systematic Assessment | Tiredness |
| |
| Tiredness at 2 hours after dilator placement | General disorders | Non-systematic Assessment | Tiredness |
| |
| Tiredness at 4 hours after dilator placement | General disorders | Non-systematic Assessment | Tiredness |
| |
| Tiredness at 8 hours after dilator placement | General disorders | Non-systematic Assessment | Tiredness |
| |
| Tiredness at 18-24 hours after dilator placment | General disorders | Non-systematic Assessment | Tiredness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Creinin, MD | University of California, Davis | 916-734-6670 | mdcreinin@ucdavis.edu |
| Feb 28, 2020 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D002266 | Carboxymethylcellulose Sodium |
| D000082 | Acetaminophen |
| D003061 | Codeine |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010666 | Phenylpropionates |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Asian |
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| Mixed |
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| Other |
|
| Declined |
|
| Fetal anomalies |
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| High school or equivalent |
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| Some college |
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| College or higher |
|
| Declined |
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