Status:
COMPLETED
Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control
Lead Sponsor:
University of Saskatchewan
Collaborating Sponsors:
Saskatoon Health Region
Conditions:
Post-Vaginal Delivery Perineal Pain
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
The primary objective of this study is to determine whether the route of administration of naproxen (either by mouth or rectally) influences post-vaginal delivery perineal pain control.
Detailed Description
Postpartum perineal pain is common after vaginal delivery. Naproxen suppositories have been shown to be effective at reducing postpartum perineal pain. To date, no studies have investigated the effica...
Eligibility Criteria
Inclusion
- Potential volunteers who meet all of the following criteria are eligible for this study:
- Active labor, whether spontaneous or induced
- Age between 18 and 40 years old
- Nulliparous
- BMI \< 40
- Single live intrauterine fetus in cephalic presentation
- Term gestation (370 weeks to 416 weeks inclusive) as defined by ultrasound or last menstrual period dating
- Intrapartum epidural labour analgesia
- Written informed consent
Exclusion
- Potential volunteers meeting one of more of the following criteria may not be enrolled:
- Medical conditions including:
- Naproxen, aspirin or other non-steroidal anti-inflammatory drug hypersensitivity
- Asthma
- Peptic ulcer disease or other inflammatory gastrointestinal disease
- Renal, hepatic or cardiac disease
- Coagulopathy
- Rectal or anal pathology including recent (within 1 month) rectal bleeding
- Prescribed medications including lithium, furosemide, antihypertensives, anticoagulants, aminoglycosides, hydantoins, or sulfonamides
- Obstetrical conditions including:
- Multiple pregnancy
- Extensive perineal trauma (third or fourth degree laceration)
- Forceps delivery
- Cesarean section delivery
- Paracervical or pudendal nerve blocks
- Vulval or vaginal hematomas
- Nulliparous women not requiring intrapartum epidural labour analgesia
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00222976
Start Date
September 1 2006
End Date
May 1 2007
Last Update
November 15 2007
Active Locations (1)
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1
Department of Anesthesia, Royal University Hospital, University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8