Perineal TearPhase 2SuPPerPNCT03041779
Comparison Between Rectal Suppository Acetaminophen and Diclofenac Sodium as Analgesia for Postpartum Perineal Tear
A Phase 2 study testing Diclofenac Sodium 50Mg Suppository and Paracetamol 500Mg Suppository in people with Perineal Tear and Perineal Laceration (Obstetric), run by Clinical Research Centre, Malaysia.
Trial summary
To assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain secondary to perineal trauma. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Perineal Tear, Perineal Laceration (Obstetric)
- What is being tested?
- Diclofenac Sodium 50Mg Suppository and Paracetamol 500Mg Suppository
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 909 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stage 1:
- All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery
- Stage 2:
- All pregnant women who have planned vaginal delivery in HSAJB from 1st January 2016 till 30th June 2016.
- All pregnant women who sustained 1st degree/ 2nd degree perineal tear or episiotomy tear post vaginal delivery.
- All pregnant women who have consented to involve in the study.
Who cannot join
- Stage 1:
- Patient who sustained additional perineal tear (eg. Labial tear or periurethral tear) following childbirth.
- Patient who developed post-partum complications.
- Stage 2:
- Patient who is allergic to paracetamol or voltaren.
- Patient who is unable to or unwilling to give consent.
Show all 9Show fewer
- Patient who is ended up with caesarean section.
- Patient who sustained additional perineal tear including labial tear or periurethral tear.
- Patient who developed postpartum complications (eg. Retained placenta, uterine atony, postpartum haemorrhage, multiple vaginal wall tear etc. )
About this study
Official title: A Single Blinded, Open-labelled, Randomized Control Trial Comparing Acetaminophen Rectal Suppository With Diclofenac Rectal Suppository as Analgesia for Perineal Injury Following Childbirth
To assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain secondary to perineal trauma.
Read the detailed description
Studies has demonstrated that non-steroidal anti-inflammatory drugs (NSAIDs) rectal suppositories are associated with less pain up to 24 hours after birth, and less additional analgesia is required. Therefore, In view of rectal route of analgesic administration is better in local action and systemic paracetamol also proven to be effective in controlling post-partum perineal pain with unknown effectiveness in its suppository form; the investigators would like to conduct this study to investigate the effectiveness of acetaminophen rectal suppository versus diclofenac rectal suppository in controlling postpartum perineal pain. This study will be conducted in 2 stages. Stage 1 is a 3 months prospective observational study which aims to determine the prevalence and severity of perineal pain following childbirth in Hospital Sultanah Aminah, Johor Bahru; while Stage 2 is a single blinded, open-labelled, randomized control trial study design which will determine if acetaminophen rectal suppository is as equivalence as diclofenac rectal suppository in reducing postpartum perineal pain secondary to perineal trauma.
- Conditions
- Perineal Tear, Perineal Laceration (Obstetric)
- Being tested
- Diclofenac Sodium 50Mg Suppository, Paracetamol 500Mg Suppository
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac Sodium 50Mg SuppositoryDrug
Also called Voltaren 50Mg Suppository
Paracetamol 500Mg SuppositoryDrug
Also called Acetaminophen 500Mg Suppository
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Active comparator | Paracetamol 500Mg Suppository Receives: Drug: Diclofenac Sodium 50Mg Suppository |
| Voltaren | Active comparator | Diclofenac Sodium 50Mg Suppository Receives: Drug: Paracetamol 500Mg Suppository |
What is being measured
The primary outcome is the main question the study is designed to answer.
perineum pain score following childbirth
Measured: at 2nd to 3rd hour post repair
Secondary outcomes (4)
perineum pain score following childbirth
Measured: immediate after delivery
perineum pain score following childbirth
Measured: immediate post perineum repair
perineum pain score following childbirth
Measured: at 5th to 6th hour post repair
perineum pain score following childbirth
Measured: prior to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Perineal TearStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 909 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woon Shu Yuan, Clinical Research Centre, Malaysia
- Investigators
- Shu Yuan Woon, MBBS, Principal investigator, O&G department, Hospital Sultanah Aminah Johor Bahru, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041779
- Sponsor's protocol ID
- NMRR-15-868-26140
- Acronym
- SuPPerP
- Status last verified
- Feb 2017
- First submitted
- 12 Dec 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cunningham G, Leveno K, Bloom S, et al. Maternal Anatomy. Williams obstetrics. 22nd Edition. New York: McGraw-Hill, 2005:21.
Albers L, Garcia J, Renfrew M, McCandlish R, Elbourne D. Distribution of genital tract trauma in childbirth and related postnatal pain. Birth. 1999 Mar;26(1):11-7. doi: 10.1046/j.1523-536x.1999.00011.x.
PubMed 10352050Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
PubMed 15507941Williams A, Herron-Marx S, Carolyn H. The prevalence of enduring postnatal perineal morbidity and its relationship to perineal trauma. Midwifery. 2007 Dec;23(4):392-403. doi: 10.1016/j.midw.2005.12.006. Epub 2006 Dec 29.
PubMed 17196714Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. doi: 10.1002/14651858.CD003931.
PubMed 12917995Chou D, Abalos E, Gyte GM, Gulmezoglu AM. Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD008407. doi: 10.1002/14651858.CD008407.pub2.
PubMed 23440827Gilman G. Drug absorption, bioavailability, and routes of administration. The pharmacological basis of therapeutics. 8th Edition. New York: Macmillan Publishing Co. 1990:7.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blinded, Open-labelled, Randomized Control Trial Comparing Acetaminophen Rectal Suppository With Diclofenac Rectal Suppository as Analgesia for Perineal Injury Following Childbirth
- ClinicalTrials.gov ID
- NCT03041779
- Acronym / sponsor ID
- SuPPerP / NMRR-15-868-26140
- Conditions
- Perineal Tear, Perineal Laceration (Obstetric)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 909 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 3 Feb 2017 (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.
To assess the prevalence of pain score for perineum pain following childbirth followed by phase 2 study to assess the analgesic effectiveness of acetaminophen and diclofenac rectal suppository in postpartum perineum pain secondary to perineal trauma.
Detailed description
Studies has demonstrated that non-steroidal anti-inflammatory drugs (NSAIDs) rectal suppositories are associated with less pain up to 24 hours after birth, and less additional analgesia is required. Therefore, In view of rectal route of analgesic administration is better in local action and systemic paracetamol also proven to be effective in controlling post-partum perineal pain with unknown effectiveness in its suppository form; the investigators would like to conduct this study to investigate the effectiveness of acetaminophen rectal suppository versus diclofenac rectal suppository in controlling postpartum perineal pain. This study will be conducted in 2 stages. Stage 1 is a 3 months prospective observational study which aims to determine the prevalence and severity of perineal pain following childbirth in Hospital Sultanah Aminah, Johor Bahru; while Stage 2 is a single blinded, open-labelled, randomized control trial study design which will determine if acetaminophen rectal suppository is as equivalence as diclofenac rectal suppository in reducing postpartum perineal pain secondary to perineal trauma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Active comparator | Drug: Diclofenac Sodium 50Mg SuppositoryParacetamol 500Mg Suppository |
| Voltaren | Active comparator | Drug: Paracetamol 500Mg SuppositoryDiclofenac Sodium 50Mg Suppository |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- All pregnant women who sustained perineal trauma (either 1st degree tear, 2nd degree tear or episiotomy) post vaginal delivery
- All pregnant women who have planned vaginal delivery in HSAJB from 1st January 2016 till 30th June 2016.
- All pregnant women who sustained 1st degree/ 2nd degree perineal tear or episiotomy tear post vaginal delivery.
- All pregnant women who have consented to involve in the study.
Key exclusion criteria (9 listed)
- Patient who sustained additional perineal tear (eg. Labial tear or periurethral tear) following childbirth.
- Patient who developed post-partum complications.
- Patient who is allergic to paracetamol or voltaren.
- Patient who is unable to or unwilling to give consent.
- Patient who is ended up with caesarean section.
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 |
|---|---|---|
| Diclofenac Sodium 50Mg SuppositoryAlso: Voltaren 50Mg Suppository | Drug | Paracetamol |
| Paracetamol 500Mg SuppositoryAlso: Acetaminophen 500Mg Suppository | Drug | Voltaren |
Primary outcome
perineum pain score following childbirth
Time frame: at 2nd to 3rd hour post repair
4 secondary outcomes
perineum pain score following childbirth
Time frame: immediate after delivery
perineum pain score following childbirth
Time frame: immediate post perineum repair
perineum pain score following childbirth
Time frame: at 5th to 6th hour post repair
perineum pain score following childbirth
Time frame: prior to discharge
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 3 Feb 2017.
- Results publicationCunningham G, Leveno K, Bloom S, et al. Maternal Anatomy. Williams obstetrics. 22nd Edition. New York: McGraw-Hill, 2005:21.
- Results publication: PubMed 10352050Albers L, Garcia J, Renfrew M, McCandlish R, Elbourne D. Distribution of genital tract trauma in childbirth and related postnatal pain. Birth. 1999 Mar;26(1):11-7. doi: 10.1046/j.1523-536x.1999.00011.x.
- Results publication: PubMed 15507941Macarthur AJ, Macarthur C. Incidence, severity, and determinants of perineal pain after vaginal delivery: a prospective cohort study. Am J Obstet Gynecol. 2004 Oct;191(4):1199-204. doi: 10.1016/j.ajog.2004.02.064.
- Results publication: PubMed 17196714Williams A, Herron-Marx S, Carolyn H. The prevalence of enduring postnatal perineal morbidity and its relationship to perineal trauma. Midwifery. 2007 Dec;23(4):392-403. doi: 10.1016/j.midw.2005.12.006. Epub 2006 Dec 29.
- Results publication: PubMed 12917995Hedayati H, Parsons J, Crowther CA. Rectal analgesia for pain from perineal trauma following childbirth. Cochrane Database Syst Rev. 2003;(3):CD003931. doi: 10.1002/14651858.CD003931.
- Results publication: PubMed 23440827Chou D, Abalos E, Gyte GM, Gulmezoglu AM. Paracetamol/acetaminophen (single administration) for perineal pain in the early postpartum period. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD008407. doi: 10.1002/14651858.CD008407.pub2.
- Results publicationGilman G. Drug absorption, bioavailability, and routes of administration. The pharmacological basis of therapeutics. 8th Edition. New York: Macmillan Publishing Co. 1990:7.
- Individual participant dataSharing planned: Undecided
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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.
Shu Yuan Woon, MBBS principal investigator
O&G department, Hospital Sultanah Aminah Johor Bahru, Malaysia
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diclofenac Sodium 50Mg Suppository and Paracetamol 500Mg Suppository in people with Perineal Tear and Perineal Laceration (Obstetric), run by Clinical Research Centre, Malaysia.
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 6 inclusion and 9 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 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
perineum pain score following childbirth (time frame: at 2nd to 3rd hour post repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03041779, which also lists 7 linked publications.
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 3 Feb 2017.