Pain Management at Latent Period of Labour

Labour Clinical Trial

Official title:

Pain Management Efficiency at Latent Period of Labour

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03105830
• Other study ID #: 0037-16-NHR-shnaider
• Status: Not yet recruiting
• Phase: N/A
• First received: February 6, 2017
• Last updated: April 7, 2017
• Start date: May 2017
• Est. completion date: June 2018

Study information

• Verified date: April 2017
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• latent phase of labour

• low risk

Exclusion Criteria:

• high risk

• allergy to paracetamol

• liver insufficiency

Related Conditions & MeSH terms

• Labour

Intervention

Drug:
• iv paracetamol
iv paracetamol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score	vas	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	level of paracetamol	samples of blood	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
Secondary	pain experience	pain scores by vas scale 0-10 scale. 0 no pain- 10 sever pain	72 hours after labor , the data will be presented through study completion, an average of 1 year
Secondary	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	72 hours after labor, the data will be presented through study completion, an average of 1 year
Secondary	pain experience and analgesia	analgesia, which kind of analgesia medicines had used	72 hours after labor, the data will be presented through study completion, an average of 1 year