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NCT03635905 · ClinicalTrials.gov registry record · Phase 4
Gabapentin for Pain Management During Dilation and Evacuation
A Phase 4 study, sponsored by Medstar Health Research Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
NCT03635905 is a Phase 4 study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 130 participants.
The verdict
NCT03635905, a Phase 4 study, has completed, sponsored by Medstar Health Research Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
Study Summary
Justification. Pain control is still an issue for women undergoing second trimester abortion procedures. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. The investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the time of cervical preparation initiation will improve intra-operative pain control. The investigators also hypothesize that it will improve pre- and post-operative pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D\&E. To test the hypotheses the investigators plan to enroll 130 participants who will be randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of cervical preparation.
Interventions
- DRUG Placebo
- DRUG Gabapentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2017-05-26 |
| Est. Completion | 2020-05-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03635905
The ClinicalTrials.gov registry entry for NCT03635905 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medstar Health Research Institute, which has 115 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03635905 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03635905 about?
NCT03635905 is a clinical study titled "Gabapentin for Pain Management During Dilation and Evacuation". Justification. Pain control is still an issue for women undergoing second trimester abortion procedures. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. The investigators hypo...
What is the current status of trial NCT03635905?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2017-05-26. Estimated completion is 2020-05-20.
What interventions are being tested in trial NCT03635905?
The interventions under investigation include: Placebo (DRUG), Gabapentin (DRUG).
Who is sponsoring clinical trial NCT03635905?
This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.
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