Working... Menu

Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01428375
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : February 6, 2013
Information provided by (Responsible Party):
Ahmed Elsayed Hassan Elbohoty, Ain Shams University

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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: (1) Active (Paracetamol) arm: n=60
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

Primary Outcome Measures :
  1. 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. ]
    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 :
  1. 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. ]
    By assessing the adverse events recorded during the study either maternal or fetal/neonatal.

  2. 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. ]
    The difference between both groups regarding labour duration

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01428375

Layout table for location information
Ain Shams Maternity Hospital
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Layout table for investigator information
Principal Investigator: Ahmed E Elbohoty, MD OB GYN Department, faculty of Medicine, ASU

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ahmed Elsayed Hassan Elbohoty, Lecturer in OB GYN, Ain Shams University Identifier: NCT01428375     History of Changes
PARACETAMOL-INTRAPARTUM ( Other Identifier: Pharma Tech company )
First Posted: September 5, 2011    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013

Keywords provided by Ahmed Elsayed Hassan Elbohoty, Ain Shams University:
intravenous paracetamol
intrapartum analgesia
labor pain
intrapartum pains

Additional relevant MeSH terms:
Layout table for MeSH terms
Labor Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs