Abortion, Induced, Cervical Preparation, Pain
Conditions
Keywords
Abortion, Osmotic dilators, Gabapentin, Text message
Brief 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. 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: 1. Women's pain experience with dilators in their cervix overnight before the abortion procedure 2. 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.
Interventions
DRUGGabapentin 600mg
Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
DRUGPlacebo oral capsule
Packaged identical to gabapentin dosing
DRUGacetaminophen/codeine and ibuprofen
Over the counter analgesic medications
Sponsors
Society of Family Planning
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion | 5 minutes 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 in person before subject leaves clinic appointment. |
| Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion | 2 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. |
| Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion | 4 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. |
| Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion) | Time of presentation for D&E (day 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 in person upon presentation for D&E procedure. |
| Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine) | Collected between each subject contact (2 hours, 4 hours, 8 hours after dilator insertion and at time of presentation for D&E procedure) | Subject account of how many used acetaminophen/codeine (standard medications given for supplement NSAID as needed after dilator insertion) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| 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 | 58 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Did not provide NRS pain results | 1 | 0 |
| Overall Study | Randomization error (parity group) | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo Oral Capsule | Total | Gabapentin |
|---|---|---|---|
| Age, Continuous | 27.2 years STANDARD_DEVIATION 6.1 | 26.2 years STANDARD_DEVIATION 5.9 | 25.4 years STANDARD_DEVIATION 5.6 |
| Education College or higher | 6 Participants | 14 Participants | 8 Participants |
| Education Declined | 1 Participants | 1 Participants | 0 Participants |
| Education High school or equivalent | 15 Participants | 45 Participants | 30 Participants |
| Education Not completed high school | 4 Participants | 10 Participants | 6 Participants |
| Education Some college | 32 Participants | 48 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 42 Participants | 85 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 31 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants | 10 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Black | 11 Participants | 22 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Declined | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Mixed | 5 Participants | 19 Participants | 14 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Race White | 34 Participants | 57 Participants | 23 Participants |
| Reasons for abortion Fetal anomalies | 7 Participants | 14 Participants | 7 Participants |
| Reasons for abortion Unwanted pregnancy | 51 Participants | 104 Participants | 53 Participants |
| Region of Enrollment United States | 58 participants | 118 participants | 60 participants |
| Sex: Female, Male Female | 58 Participants | 118 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 58 |
| other Total, other adverse events | 57 / 60 | 51 / 58 |
| serious Total, serious adverse events | 0 / 60 | 0 / 58 |
Outcome results
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.
Time frame: 8 hours after insertion of last osmotic dilator
Population: Women who responded with pain scores by text using Numeric Rating Scale
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion | 2 Numeric rating scale pain score change |
| Placebo Oral Capsule | Mean Change From Baseline in NRS Pain Score at 8 Hours After Dilator Insertion | 2.5 Numeric rating scale pain score change |
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.
Time frame: 2 hours after insertion of last osmotic dilator
Population: Women who responded by text with numeric pain scale score
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion | 3.5 Numeric rating scale pain score change |
| Placebo Oral Capsule | Mean Change From Baseline in NRS Pain Score at 2 Hours After Dilator Insertion | 4 Numeric rating scale pain score change |
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.
Time frame: 4 hours after insertion of last osmotic dilator
Population: Women who responded by text with numeric pain scale score
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gabapentin | Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion | 3 Numeric rating scale pain score change |
| Placebo Oral Capsule | Mean Change From Baseline in NRS Pain Score at 4 Hours After Dilator Insertion | 3.5 Numeric rating scale pain score change |
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.
Time frame: 5 minutes after insertion of last osmotic dilator
Population: Women who provided Numeric rating scale pain score
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion | 1 Numeric rating scale pain score change |
| Placebo Oral Capsule | Mean Change From Baseline in NRS Pain Score at 5 Minutes After Last Dilator Insertion | 2 Numeric rating scale pain score change |
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.
Time frame: Time of presentation for D&E (day after dilator insertion)
Population: Women who provided numeric pain scale scores
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion) | 0.5 Numeric rating scale pain score change |
| Placebo Oral Capsule | Mean Change From Baseline in NRS Pain Score at Time of Presentation for D&E Procedure (Day Following Dilator Insertion) | 1 Numeric rating scale pain score change |
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)
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)
Population: Any use of narcotics
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gabapentin | Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine) | 35 Participants |
| Placebo Oral Capsule | Number of Participants Using Narcotic Pain Medication (Acetaminophen/Codeine) | 40 Participants |