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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: Completed Phase 4 study, sponsored by Northwestern University.
NCT03470675 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 67 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good)and 10 highest pain (poor).
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 |
What the finished NCT03470675 record still lists
NCT03470675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Epidural saline + IV saline is the first listed.
NCT03470675 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03470675's enrollment target sits among peer trials
67 1083rd of 2000 higher than 918 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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