Labor PainPhase 3NCT01817829
Oral Paracetamol as Preemptive Analgesia for Labor Pain
A Phase 3 study testing paracetamol in people with Labor Pain, run by Ain Shams University.
Trial summary
It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jun 2012
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- primigravida
- The gestational age between 37- 42 weeks
- Not seeking analgesia
- Singleton pregnancy
- vertex
- Spontaneous onset of labour
- 1st stage of labour (less than 5 cm)
Who cannot join
- Extreme of age (below18-above 40)
- Multiparous
- Multiple gestation
- Malpresentation
- Congenital or acquired pelvic abnormalities(eg. Poliomyelitis)
- Any medical disorder with pregnancy
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- Induction of labour
- Advanced 1st stage > 5 cm
- Use of any other kind of analgesia before recruitment in the study
- Scared uterus
- Fetal distress
About this study
It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.
Read the detailed description
It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.
- Conditions
- Labor Pain
- Being tested
- paracetamol, placebo
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
500 mg oral tablet
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| paracetamol | Active comparator | paracetamol 2 tablets1000mg PO. Receives: Drug: paracetamol |
| placebo | Placebo comparator | placebo 2 tablets containing Starch PO Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy
To document the efficacy of oral paracetamol, in pregnant women in labor, as demonstrated by the degree of pain relief and need for additional analgesia during the labor process and the early postpartum period.
Measured: intrapartum
Secondary outcomes (2)
Safety
To document safety and evaluate adverse events recorded during the study either maternal or fetal.
Measured: Start of medication till 24 hours postpartum
Duration of labor
To assess the effect of the duration of labor.
Measured: Start of medication till delivery of fetus.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startDec 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Elsayed Hassan Elbohoty, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817829
- Sponsor's protocol ID
- OPPALP
- Other IDs
- Personal
- Status last verified
- Mar 2013
- First submitted
- 4 Feb 2013
- Last updated
- 26 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Paracetamol as Preemptive Analgesia for Labor Pain
- ClinicalTrials.gov ID
- NCT01817829
- Acronym / sponsor ID
- OPPALP
- Conditions
- Labor Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 26 Mar 2013 (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.
It is a double blinded randomized control trial assessing the use of Oral paracetamol in managing the intrapartum pain.
Detailed description
It is a double blinded randomized control trial comparing the use of Oral paracetamol to placebo in managing the intrapartum pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paracetamol | Active comparator | Drug: paracetamolparacetamol 2 tablets1000mg PO. |
| placebo | Placebo comparator | Drug: placeboplacebo 2 tablets containing Starch PO |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- primigravida
- The gestational age between 37- 42 weeks
- Not seeking analgesia
- Singleton pregnancy
- vertex
Key exclusion criteria (11 listed)
- Extreme of age (below18-above 40)
- Multiparous
- Multiple gestation
- Malpresentation
- Congenital or acquired pelvic abnormalities(eg. Poliomyelitis)
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 |
|---|---|---|
| paracetamol500 mg oral tablet | Drug | paracetamol |
| placebo | Drug | placebo |
Primary outcome
Efficacy
Time frame: intrapartum
To document the efficacy of oral paracetamol, in pregnant women in labor, as demonstrated by the degree of pain relief and need for additional analgesia during the labor process and the early postpartum period.
2 secondary outcomes
Safety
Time frame: Start of medication till 24 hours postpartum
Duration of labor
Time frame: Start of medication till delivery of fetus.
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 26 Mar 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing paracetamol in people with Labor Pain, run by Ain Shams University.
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 7 inclusion and 11 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 26 Mar 2013. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy (time frame: intrapartum). 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 26 Mar 2013.