search
Back to results

Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

Primary Purpose

Labor Pain

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
(1) Paracetamol injection
Sterile water
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring intravenous paracetamol, intrapartum analgesia, labor pain, intrapartum pains

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

(1) Active (Paracetamol) arm: n=60

(2) Placbo (Sterile water) arm: n=60

Arm Description

(Paracetamol)

Sterile water

Outcomes

Primary Outcome Measures

To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
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
By assessing the adverse events recorded during the study either maternal or fetal/neonatal.
To correlate with the duration of labor
The difference between both groups regarding labour duration

Full Information

First Posted
August 15, 2011
Last Updated
February 4, 2013
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT01428375
Brief Title
Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor
Official Title
Evaluation of Intravenous Infusion of Paracetamol as Intrapartum Analgesic in the First Stage of Labor: a Double-blind Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 intrapartum analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain
Keywords
intravenous paracetamol, intrapartum analgesia, labor pain, intrapartum pains

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
(1) Active (Paracetamol) arm: n=60
Arm Type
Active Comparator
Arm Description
(Paracetamol)
Arm Title
(2) Placbo (Sterile water) arm: n=60
Arm Type
Placebo Comparator
Arm Description
Sterile water
Intervention Type
Drug
Intervention Name(s)
(1) Paracetamol injection
Intervention Description
Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion
Intervention Type
Other
Intervention Name(s)
Sterile water
Intervention Description
Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion
Primary Outcome Measure Information:
Title
To assess the efficacy of intravenous infusion of paracetamol in comparison with placebo (sterile water for injection) in labouring women
Description
By recoding the need for a rescue additional analgesia and measuring the degree of pain relief (Visual analogue score) during the labor process.
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.
Secondary Outcome Measure Information:
Title
To document safety
Description
By assessing the adverse events recorded during the study either maternal or fetal/neonatal.
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.
Title
To correlate with the duration of labor
Description
The difference between both groups regarding labour duration
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed E Elbohoty, MD
Organizational Affiliation
OB GYN Department, faculty of Medicine, ASU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
25132459
Citation
Abd-El-Maeboud KH, Elbohoty AE, Mohammed WE, Elgamel HM, Ali WA. Intravenous infusion of paracetamol for intrapartum analgesia. J Obstet Gynaecol Res. 2014 Nov;40(11):2152-7. doi: 10.1111/jog.12465. Epub 2014 Aug 11.
Results Reference
derived

Learn more about this trial

Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

We'll reach out to this number within 24 hrs