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Pain Management at Latent Period of Labour

Pain Management Efficiency at Latent Period of Labour

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03105830
Enrollment
150
Registered
2017-04-10
Start date
2017-05-31
Completion date
2018-06-30
Last updated
2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour

Brief 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

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. 1. women, will be identified in the reception room of a delivery room by midwives. 2. The research team will ask for consent after receiving an explanation and confirmation of understanding. 3. The midwife will perform and will record pain assessment by visual analog scores . 4. 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. 5. 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 6. At the end of the birth fetal blood sample taken from the placenta for testing the level of paracetamol. 7. At the end of a blood sample taken birth for the client in liver function tests. 8. 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.

Interventions

iv paracetamol

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* latent phase of labour * low risk

Exclusion criteria

* high risk * allergy to paracetamol * liver insufficiency

Design outcomes

Primary

MeasureTime frameDescription
pain scorepain 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 yearvas

Secondary

MeasureTime frameDescription
level of paracetamolat 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 yearsamples of blood
pain experience72 hours after labor , the data will be presented through study completion, an average of 1 yearpain scores by vas scale 0-10 scale. 0 no pain- 10 sever pain
pain influences72 hours after labor, the data will be presented through study completion, an average of 1 yearinfluences 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
pain experience and analgesia72 hours after labor, the data will be presented through study completion, an average of 1 yearanalgesia, which kind of analgesia medicines had used

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026