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NCT01513447 · ClinicalTrials.gov registry record · NA
Intracutaneous Sterile Water Injections
A NA study, sponsored by Northwestern University.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT01513447 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 8 participants.
The verdict
NCT01513447, a NA study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study Summary
For most women, the most significant pain they will experience is the pain associated with childbirth. Up to one-third of women experience "back labor", this typically occurs when the fetus assumes varying degrees of malposition, especially the occiput posterior position, and causes additional constant pressure against the maternal spine and pelvis. "Back labor" presents as constant pain, that occurs even between contractions. It is often difficult to manage, by the patient, the obstetrician, and the anesthesiologist, and may increase the rate of instrumental and caesarian delivery. Epidural anesthesia/analgesia is the most common and effective intervention used to help women cope with labor pain. Dilute concentrations of local anesthetic and opioid provide complete analgesia for most women. Some women, however, have breakthrough pain, often due to "back labor," and require more concentrated drug solutions. This increases the side effects associated with these drugs (e.g., hypotension, pruritus, motor block), thus treatment of this pain poses a challenge for the anesthesiologist and the obstetrician. Sterile water injections (SWI) are a simple and well-established method of managing labor pain among midwives. This intervention was first used to alleviate pain associated with kidney stones, and was introduced to obstetrics in the 1970s. Using a syringe, small amounts of sterile water is deposited subcutaneously near the sacral area. The sterile water causes osmotic and mechanical irritation resulting in a brief (15-30 second) and significant stinging sensation. The onset of pain relief follows almost immediately and may last for up to two hours. The procedure can be repeated a number of times. Sterile water for pain management is most often administered using four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 cm below and 1-2 cm medial to the original two injection sites. 0.1 mL of sterile water is injected between the der
Interventions
- DRUG Intracutaneous injections
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01513447
The ClinicalTrials.gov registry entry for NCT01513447 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 8 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 1 intervention - of which Intracutaneous injections is the first listed.
NCT01513447 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01513447 about?
NCT01513447 is a clinical study titled "Intracutaneous Sterile Water Injections". For most women, the most significant pain they will experience is the pain associated with childbirth. Up to one-third of women experience "back labor", this typically occurs when the fetus assumes varying degrees of malposition, especially the occiput posterior position, and causes additional const...
What is the current status of trial NCT01513447?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2011-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01513447?
The interventions under investigation include: Intracutaneous injections (DRUG).
Who is sponsoring clinical trial NCT01513447?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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