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Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ahmed Elsayed Hassan Elbohoty, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01428375
First received: August 15, 2011
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of Paracetamol as intrapartum analgesic in the first stage of labour.


Condition Intervention Phase
Labor Pain
 Drug: (1) Paracetamol injection
Other: Sterile water
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Drinking Water
U.S. FDA Resources

Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women [ Time Frame: Start of medication till end of first stage of labour. Participants will be followed for the duration of labour, an expected average of 8 hours. ] [ Designated as safety issue: No ]
    By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process.


Secondary Outcome Measures:
  • To document safety [ Time Frame: Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours. ] [ Designated as safety issue: Yes ]
    By assessing the adverse events recorded during the study either maternal or fetal/neonatal.

  • To correlate with the duration of labor [ Time Frame: Start of medication till end of second stage of labour. Participants will be followed for the duration of labour, an expected average of 9 hours. ] [ Designated as safety issue: No ]
    The difference between both groups regarding labour duration


Estimated Enrollment: 120
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: (1) Active (Paracetamol) arm: n=60
(Paracetamol)
 Drug: (1) Paracetamol injection
Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion
Placebo Comparator: (2) Placbo (Sterile water) arm: n=60
Sterile water
 Other: Sterile water
Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion

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 intrapartum analgesia.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age between 18-35 years.
  2. Primigravida.
  3. The gestational age between 37- 42 weeks.
  4. Patient seeking analgesia.
  5. Single viable fetus.
  6. Vertex presentation.
  7. Spontaneous onset of labor.
  8. 1st stage of labor with cervical dilatation 3-4 cm ( in active phase).

Exclusion Criteria:

  1. Extreme of age (below 18-above 35).
  2. Multiparity.
  3. Multiple gestation.
  4. Malpresentation.
  5. Major degree of cephalopelvic disproportion.
  6. Any medical disorder with pregnancy e.g., Rheumatic heart disease, Diabetes mellitus, Hypertension, Anemia.
  7. Induction of labor.
  8. Cervical dilatation exceeds exceeding 4 cm.
  9. Use of any other kind of analgesia before recruitment in the study.
  10. Scared uterus.
  11. Fetal distress.
  12. Antepartum hemorrhage.
  13. Intrapartum bleeding.
  14. Polyhydramnios.
  15. Pre-mature rupture of membranes.
  16. Intra uterine infections.
  17. Hypersensitivity to paracetamol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428375

Locations
Egypt
Ain Shams Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: Ahmed E Elbohoty, MD OB GYN Department, faculty of Medicine, ASU
  More Information

No publications provided

Responsible Party: Ahmed Elsayed Hassan Elbohoty, Lecturer in OB GYN, Ain Shams University
ClinicalTrials.gov Identifier: NCT01428375     History of Changes
Other Study ID Numbers: PARACETAMOL-INTRAPARTUM, PARACETAMOL-INTRAPARTUM
Study First Received: August 15, 2011
Last Updated: February 4, 2013
Health Authority: Egypt: Ain Shams College of Medicine Research and Ethics Committee

Keywords provided by Ain Shams University:
intravenous paracetamol
intrapartum analgesia
labor pain
intrapartum pains

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Antipyretics
Physiological Effects of Drugs
 Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013