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NCT03470675 · ClinicalTrials.gov registry record · Phase 4
Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 67
- Enrollment target
NCT03470675 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 67 participants.
The verdict
NCT03470675, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 67 participants
- Enrollment target
Study Summary
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS. This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS. The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
Interventions
- DRUG Epidural saline + IV saline
- DRUG Epidural morphine 3 mg + IV saline
- DRUG Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2024-06-20 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03470675
The ClinicalTrials.gov registry entry for NCT03470675 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Epidural saline + IV saline is the first listed.
NCT03470675 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03470675 about?
NCT03470675 is a clinical study titled "Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries". Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women...
What is the current status of trial NCT03470675?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 67 participants. The study started on 2018-06-27. Estimated completion is 2024-06-20.
What interventions are being tested in trial NCT03470675?
The interventions under investigation include: Epidural saline + IV saline (DRUG), Epidural morphine 3 mg + IV saline (DRUG), Epidural morphine 3 mg + IV ketamine 0.3 mg/kg (DRUG).
Who is sponsoring clinical trial NCT03470675?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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