Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

February 4, 2013 updated by: Ahmed Elsayed Hassan Elbohoty, Ain Shams University

Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Start of medication till delivery and neonatal assesment. Participants will be followed during this duration of labour, an expected average of 10 hours.
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
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

August 15, 2011

First Submitted That Met QC Criteria

September 1, 2011

First Posted (ESTIMATE)

September 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PARACETAMOL-INTRAPARTUM (OTHER: Pharma Tech company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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