LabourNCT03105830
Pain Management at Latent Period of Labour
A study testing iv paracetamol in people with Labour, run by Western Galilee Hospital-Nahariya.
Trial summary
Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor. Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug in blood Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour
- What is being tested?
- iv paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2017to Jun 2018
- Phase
- Interventional
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- latent phase of labour
- low risk
Who cannot join
- high risk
- allergy to paracetamol
- liver insufficiency
About this study
Official title: Pain Management Efficiency at Latent Period of Labour
Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor.
Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug in blood
Read the detailed description
Maternity are latent or first stage of labor and complained of pain at the level of 4 or higher on a scale VAS, and are not in risk (HIGH RISK). And did not receive analgesics within 4 hours.
The sample will consist of at least 100 women in labor.
- women, will be identified in the reception room of a delivery room by midwives.
- The research team will ask for consent after receiving an explanation and confirmation of understanding.
- The midwife will perform and will record pain assessment by visual analog scores .
- Maternity reported pain level 4 and above will be asked four questions out of data collection and offered them treatment I.V. PARACETAMOL 1gr as directed by the physician.
- After giving I.V. PARACETAMOL 1g, carried out and documented estimate of the pain returns (by visual analog scores) after an hour wait at any time to wait four hours and two hours after birth. In cases of an outbreak of pain can give one of the following: Option A: Another portion of the I.V. PARACETAMOL 1gr within 4-6 hours the previous dose. The maximum daily dose of 4 grams. Option B: N2O by procedure A third possibility: Epidural physician approval
- At the end of the birth fetal blood sample taken from the placenta for testing the level of paracetamol.
- At the end of a blood sample taken birth for the client in liver function tests.
- Interview woman with postpartum questionnaire will be made during her stay in the maternity ward.
Filling out a questionnaire that includes demographic data and about the process of birth, medical records.
- Conditions
- Labour
- Being tested
- iv paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iv paracetamolDrug
Also called perfalgan
iv paracetamol
| Study group | Role | What they receive |
|---|---|---|
| intervention and data collection | Experimental | pain management by iv paracetamol Receives: Drug: iv paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
vas
Measured: pain assessmant by vas scale during the latent phase of labor at delivery room. the data will be presented through study completion, an average of 1 year
Secondary outcomes (4)
level of paracetamol
samples of blood
Measured: at the end of labor , blood samples from the mother and from the umbelical cord. the data will be presented through study completion, an average of 1 year
pain experience
pain scores by vas scale 0-10 scale. 0 no pain- 10 sever pain
Measured: 72 hours after labor , the data will be presented through study completion, an average of 1 year
pain influences
influences of pain on daily activities, BPI scale behavioral pain scale , the inflouences of pain on movement, breast feeding, taking a bath, talking with visitors, 0- no influencs, 10 very much
Measured: 72 hours after labor, the data will be presented through study completion, an average of 1 year
pain experience and analgesia
analgesia, which kind of analgesia medicines had used
Measured: 72 hours after labor, the data will be presented through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study startMay 2017 (estimated)
- Primary completion20 Apr 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LabourStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oleg Shnaider, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105830
- Sponsor's protocol ID
- 0037-16-NHR-shnaider
- Status last verified
- Apr 2017
- First submitted
- 6 Feb 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management Efficiency at Latent Period of Labour
- ClinicalTrials.gov ID
- NCT03105830
- Acronym / sponsor ID
- 0037-16-NHR-shnaider
- Conditions
- Labour
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- May 2017 (estimated)
- Primary completion
- 20 Apr 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 10 Apr 2017 (actual)
- 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.
Examine the effectiveness of an analgesic in PERFALGAN maternity latent phase of labor.
Examine the safety in PERFALGAN in the mother and the newborn in terms of the level of drug in blood
Detailed description
Maternity are latent or first stage of labor and complained of pain at the level of 4 or higher on a scale VAS, and are not in risk (HIGH RISK). And did not receive analgesics within 4 hours.
The sample will consist of at least 100 women in labor.
- women, will be identified in the reception room of a delivery room by midwives.
- The research team will ask for consent after receiving an explanation and confirmation of understanding.
- The midwife will perform and will record pain assessment by visual analog scores .
- Maternity reported pain level 4 and above will be asked four questions out of data collection and offered them treatment I.V. PARACETAMOL 1gr as directed by the physician.
- After giving I.V. PARACETAMOL 1g, carried out and documented estimate of the pain returns (by visual analog scores) after an hour wait at any time to wait four hours and two hours after birth. In cases of an outbreak of pain can give one of the following: Option A: Another portion of the I.V. PARACETAMOL 1gr within 4-6 hours the previous dose. The maximum daily dose of 4 grams. Option B: N2O by procedure A third possibility: Epidural physician approval
- At the end of the birth fetal blood sample taken from the placenta for testing the level of paracetamol.
- At the end of a blood sample taken birth for the client in liver function tests.
- Interview woman with postpartum questionnaire will be made during her stay in the maternity ward.
Filling out a questionnaire that includes demographic data and about the process of birth, medical records.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention and data collection | Experimental | Drug: iv paracetamolpain management by iv paracetamol |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- latent phase of labour
- low risk
Key exclusion criteria (3 listed)
- high risk
- allergy to paracetamol
- liver insufficiency
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 |
|---|---|---|
| iv paracetamolAlso: perfalganiv paracetamol | Drug | intervention and data collection |
Primary outcome
pain score
Time frame: pain assessmant by vas scale during the latent phase of labor at delivery room. the data will be presented through study completion, an average of 1 year
vas
4 secondary outcomes
level of paracetamol
Time frame: at the end of labor , blood samples from the mother and from the umbelical cord. the data will be presented through study completion, an average of 1 year
pain experience
Time frame: 72 hours after labor , the data will be presented through study completion, an average of 1 year
pain influences
Time frame: 72 hours after labor, the data will be presented through study completion, an average of 1 year
pain experience and analgesia
Time frame: 72 hours after labor, the data will be presented through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing iv paracetamol in people with Labour, run by Western Galilee Hospital-Nahariya.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Apr 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.
Are results available for this study?
Results are not available in the source record.
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?
pain score (time frame: pain assessmant by vas scale during the latent phase of labor at delivery room. the data will be presented through study completion, an average of 1 year). 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 10 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.