Labor PainPhase 3NCT01428375
Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor
A Phase 3 study testing (1) Paracetamol injection and Sterile water in people with Labor Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- (1) Paracetamol injection and Sterile water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2011to Oct 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-35 years.
- Primigravida.
- The gestational age between 37- 42 weeks.
- Patient seeking analgesia.
- Single viable fetus.
- Vertex presentation.
- Spontaneous onset of labor.
- 1st stage of labor with cervical dilatation 3-4 cm ( in active phase).
Who cannot join
- Extreme of age (below 18-above 35).
- Multiparity.
- Multiple gestation.
- Malpresentation.
- Major degree of cephalopelvic disproportion.
- Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia.
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- Induction of labor.
- Cervical dilatation exceeds exceeding 4 cm.
- Use of any other kind of analgesia before recruitment in the study.
- Scared uterus.
- Fetal distress.
- Antepartum hemorrhage.
- Intrapartum bleeding.
- Polyhydramnios.
- Pre-mature rupture of membranes.
- Intra uterine infections.
- Hypersensitivity to paracetamol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial
This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.
Read the detailed description
Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.
- Conditions
- Labor Pain
- Being tested
- (1) Paracetamol injection, Sterile water
- Keywords
- intravenous paracetamol, intrapartum analgesia, labor pain, intrapartum pains
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(1) Paracetamol injectionDrug
Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion
Sterile waterOther
Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| (1) Active (Paracetamol) arm: n=60 | Active comparator | (Paracetamol) Receives: Drug: (1) Paracetamol injection |
| (2) Placbo (Sterile water) arm: n=60 | Placebo comparator | Sterile water Receives: Other: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process.
Measured: Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours.
Secondary outcomes (2)
To document safety
By assessing the adverse events recorded during the study either maternal or fetal/neonatal.
Measured: Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours.
To correlate with the duration of labor
The difference between both groups regarding labour duration
Measured: Start of medication till end of second stage of labour. Participants will be followed for the duration of labour, an expected average of 9 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 120 participants (estimated)
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
- Investigators
- Ahmed E Elbohoty, MD, Principal investigator, OB GYN Department, faculty of Medicine, ASU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428375
- Sponsor's protocol ID
- PARACETAMOL-INTRAPARTUM
- Other IDs
- PARACETAMOL-INTRAPARTUM
- Status last verified
- Feb 2013
- First submitted
- 15 Aug 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Abd-El-Maeboud KH, Elbohoty AE, Mohammed WE, Elgamel HM, Ali WA. Intravenous infusion of paracetamol for intrapartum analgesia. J Obstet Gynaecol Res. 2014 Nov;40(11):2152-7. doi: 10.1111/jog.12465. Epub 2014 Aug 11.
PubMed 25132459
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT01428375
- Acronym / sponsor ID
- PARACETAMOL-INTRAPARTUM
- Conditions
- Labor Pain
- Keywords
- intravenous paracetamol, intrapartum analgesia, labor pain, intrapartum pains
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 5 Sep 2011 (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.
This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.
Detailed description
Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo (intravenous sterile water infusion) in parturient women in active first phase of labour and requiring intrapartum analgesia.
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 |
|---|---|---|
| (1) Active (Paracetamol) arm: n=60 | Active comparator | Drug: (1) Paracetamol injection(Paracetamol) |
| (2) Placbo (Sterile water) arm: n=60 | Placebo comparator | Other: Sterile waterSterile water |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18-35 years.
- Primigravida.
- The gestational age between 37- 42 weeks.
- Patient seeking analgesia.
- Single viable fetus.
Key exclusion criteria (17 listed)
- Extreme of age (below 18-above 35).
- Multiparity.
- Multiple gestation.
- Malpresentation.
- Major degree of cephalopelvic disproportion.
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 |
|---|---|---|
| (1) Paracetamol injectionDrugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion | Drug | (1) Active (Paracetamol) arm: n=60 |
| Sterile waterDrugs: (2) Bottle containing 100 ml sterile water for intravenous infusion | Other | (2) Placbo (Sterile water) arm: n=60 |
Primary outcome
To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
Time frame: Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours.
By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process.
2 secondary outcomes
To document safety
Time frame: Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours.
To correlate with the duration of labor
Time frame: Start of medication till end of second stage of labour. Participants will be followed for the duration of labour, an expected average of 9 hours.
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 6 Feb 2013.
- Derived from this study: PubMed 25132459Abd-El-Maeboud KH, Elbohoty AE, Mohammed WE, Elgamel HM, Ali WA. Intravenous infusion of paracetamol for intrapartum analgesia. J Obstet Gynaecol Res. 2014 Nov;40(11):2152-7. doi: 10.1111/jog.12465. Epub 2014 Aug 11.
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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.
Ahmed E Elbohoty, MD principal investigator
OB GYN Department, faculty of Medicine, ASU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing (1) Paracetamol injection and Sterile water in people with Labor Pain, run by Ain Shams University at 1 site in Egypt.
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 8 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 6 Feb 2013. 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 Egypt. 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. 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?
To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women (time frame: Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours.). 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 NCT01428375, which also lists 1 linked publication.
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 6 Feb 2013.