Status:
COMPLETED
Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor
Lead Sponsor:
Ain Shams University
Conditions:
Labor Pain
Eligibility:
FEMALE
18-35 years
Phase:
PHASE3
Brief 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.
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 intrapart...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01428375
Start Date
August 1 2011
End Date
October 1 2012
Last Update
February 6 2013
Active Locations (1)
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1
Ain Shams Maternity Hospital
Cairo, Egypt