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NCT03080493 · ClinicalTrials.gov registry record · Phase 4
Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial
A Phase 4 study, sponsored by University of California, Davis.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
NCT03080493 is a Phase 4 study that has completed, run by University of California, Davis. The registered enrollment target is 121 participants.
The verdict
NCT03080493, a Phase 4 study, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
Study 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 th
Interventions
- DRUG Placebo oral capsule
- DRUG Gabapentin 600mg
- DRUG acetaminophen/codeine and ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2017-03-20 |
| Est. Completion | 2018-11-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03080493
The ClinicalTrials.gov registry entry for NCT03080493 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo oral capsule is the first listed.
NCT03080493 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03080493 about?
NCT03080493 is a clinical study titled "Gabapentin for Pain Control After Osmotic Dilator Insertion and Prior to D&E Procedure: a Randomized Controlled Trial". 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 ex...
What is the current status of trial NCT03080493?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2017-03-20. Estimated completion is 2018-11-05.
What interventions are being tested in trial NCT03080493?
The interventions under investigation include: Placebo oral capsule (DRUG), Gabapentin 600mg (DRUG), acetaminophen/codeine and ibuprofen (DRUG).
Who is sponsoring clinical trial NCT03080493?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
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