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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: Completed Phase 4 study, sponsored by Medstar Health Research Institute.
NCT03635905 is a Phase 4 study that has completed, run by Medstar Health Research Institute. The registered enrollment target is 130 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured on 100-mm visual analog scale (higher score = more pain)
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 |
What the finished NCT03635905 record still lists
NCT03635905 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03635905 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03635905's enrollment target sits among peer trials
130 622nd of 2000 higher than 1,370 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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