Post-Vaginal Delivery Perineal PainPhase 4NCT00222976
Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control
A Phase 4 study testing Naproxen in people with Post-Vaginal Delivery Perineal Pain, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Vaginal Delivery Perineal Pain
- What is being tested?
- Naproxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to May 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- Term gestation (370 weeks to 416 weeks inclusive) as defined by ultrasound or last menstrual period dating
- Intrapartum epidural labour analgesia
- Written informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Anesthesia, Royal University Hospital, University of Saskatchewan
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial
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.
Read the 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 efficacy of oral naproxen for perineal pain control. Currently, rectal naproxen is used postpartum because of an assumption that there is a "local effect" compared to oral administration. However, this effect has never been documented in the literature.
Principles of pharmacology dictate that the least invasive route of drug administration should be used when two or more routes are equally effective. If oral and rectal naproxen are equally efficacious at controlling post-vaginal delivery perineal pain, then current practice would be challenged.
The primary objective of this study is to determine whether the route of administration of naproxen influences post-vaginal delivery perineal pain control. Pain scores will be measured using a visual analog scale. The secondary outcome measures are three-fold: patient preference of route of administration, medication adverse effects, and additional requests for analgesia. The working hypothesis is that there is no difference in pain control between oral and rectal administration and that patients will prefer the oral route.
- Conditions
- Post-Vaginal Delivery Perineal Pain
- Being tested
- Naproxen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | A Naproxen PO + placebo PR Receives: Drug: Naproxen |
| 2 | Experimental | B Placebo PO + Naproxen PR Receives: Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-vaginal delivery perineal pain scores will be measured using a visual analog scale.
Measured: 1 day
Secondary outcomes (3)
patient preference of route of administration
Measured: 1 day
medication adverse effects
Measured: until completion of study
additional requests for analgesia.
Measured: until completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Vaginal Delivery Perineal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatoon Health Region
- Investigators
- David C Campbell, MD,MSC,FRCPC, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222976
- Sponsor's protocol ID
- Bio-REB 05-96
- Status last verified
- Nov 2007
- First submitted
- 19 Sep 2005
- Last updated
- 15 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral vs Rectal Administration of Naproxen for Post-Vaginal Perineal Pain Control: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00222976
- Acronym / sponsor ID
- Bio-REB 05-96
- Conditions
- Post-Vaginal Delivery Perineal Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatoon Health Region
- Study start
- Sep 2006
- Study completion
- May 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 efficacy of oral naproxen for perineal pain control. Currently, rectal naproxen is used postpartum because of an assumption that there is a "local effect" compared to oral administration. However, this effect has never been documented in the literature.
Principles of pharmacology dictate that the least invasive route of drug administration should be used when two or more routes are equally effective. If oral and rectal naproxen are equally efficacious at controlling post-vaginal delivery perineal pain, then current practice would be challenged.
The primary objective of this study is to determine whether the route of administration of naproxen influences post-vaginal delivery perineal pain control. Pain scores will be measured using a visual analog scale. The secondary outcome measures are three-fold: patient preference of route of administration, medication adverse effects, and additional requests for analgesia. The working hypothesis is that there is no difference in pain control between oral and rectal administration and that patients will prefer the oral route.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: NaproxenA Naproxen PO + placebo PR |
| 2 | Experimental | Drug: NaproxenB Placebo PO + Naproxen PR |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Potential volunteers who meet all of the following criteria are eligible for this study:
Key exclusion criteria (17 listed)
- Potential volunteers meeting one of more of the following criteria may not be enrolled:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaproxenTreatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR | Drug | 1, 2 |
Primary outcome
post-vaginal delivery perineal pain scores will be measured using a visual analog scale.
Time frame: 1 day
3 secondary outcomes
patient preference of route of administration
Time frame: 1 day
medication adverse effects
Time frame: until completion of study
additional requests for analgesia.
Time frame: until completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2007.
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Recruiting
Physiotherapeutic Protocol Compared to Usual Care in the Treatment of Primiparas After Perineal Trauma
Episiotomy, Lacerations Perineal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Campbell, MD,MSC,FRCPC principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen in people with Post-Vaginal Delivery Perineal Pain, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-vaginal delivery perineal pain scores will be measured using a visual analog scale. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2007.