Clinical trial NCT03105830: Pain Management at Latent Period of Labour
Official title: Pain Management Efficiency at Latent Period of Labour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labour
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2017-04-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* latent phase of labour
* low risk

Exclusion Criteria:

* high risk
* allergy to paracetamol
* liver insufficiency

Primary outcomes:
measure: pain score
timeFrame: 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:
measure: level of paracetamol
timeFrame: 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
measure: pain experience
timeFrame: 72 hours after labor , the data will be presented through study completion, an average of 1 year
measure: pain influences
timeFrame: 72 hours after labor, the data will be presented through study completion, an average of 1 year
measure: pain experience and analgesia
timeFrame: 72 hours after labor, the data will be presented through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References: