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Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

Primary Purpose

Labor Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
paracetamol-pethidine
Sponsored by
Menoufia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Primiparous
  • aged 18-35 years,
  • Term live singleton pregnancy,
  • Vertex presentation,
  • Spontaneous onset of labor at term 37-42 weeks gestation,
  • In active phase of of 1st stage of labour (cervix dilatation 3- 4 cm).

Exclusion Criteria:

Clinical evidence of cephalopelvic disproportion

  • Use of any kind of analgesia prior to study
  • Any medical disorder during pregnancy (liver or kidney impairment)
  • Induction of labor, Intrauterine fetal death
  • Evidence of fetal distress
  • Antenatal diagnosis of congenital malformation
  • Previous history of hypersensitivity to either drug
  • Extremes of age (i.e. below 18 or above 35)
  • Multiple pregnancies
  • Cervical dilatation more than 6 cm.

Sites / Locations

  • Menoufia University hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

paracetamol group

pethidine group

Arm Description

Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%].

Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%].

Outcomes

Primary Outcome Measures

change of the intensity of perceived labor pain.
Labour pain was semi-objectively assessed using the visual analogue scale (VAS). In this technique, the patient is shown a ten cm line which represent at one end no pain and the other worst pain, and the patient is asked to point on the line where her pain lies. This scale has the added advantage that the pain can be given a numerical value.

Secondary Outcome Measures

duration of the active phase of the 1st stage of labor
duration of the 2nd stage of labor
need for further analgesia
maternal dizziness, nausea and/or vomiting
mode of delivery (vaginal or by caesarian
1- and 5-minutes Apgar scores.
need for neonatal resuscitation
need for NICU admission
Neonatal respiratory distress .

Full Information

First Posted
February 1, 2021
Last Updated
February 4, 2021
Sponsor
Menoufia University
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1. Study Identification

Unique Protocol Identification Number
NCT04744727
Brief Title
Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain
Official Title
Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain in a Low Resource Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
May 10, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains
Detailed Description
investigators conducted a randomized clinical study included including 96 primiparous women admitted to Obstetrics and Gynecology Department, Menoufia University Hospitals, starting the study from May 2019 to March 2020 to assess the use of paracetamol intravenously versus Pethidine HCL intravenously in management of intrapartum pain. After obtaining approval from the local ethics committee, women who agreed to participate gave their signed informed consent after explanation of the trial benefits and hazards

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cases were divided into 2 groups: Group I (paracetamol group): Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. Group 2 (pethidine group): Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. Randomization was done by a computer-generated randomization system. Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
Masking
Participant
Masking Description
Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
paracetamol group
Arm Type
Active Comparator
Arm Description
Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%].
Arm Title
pethidine group
Arm Type
Active Comparator
Arm Description
Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%].
Intervention Type
Drug
Intervention Name(s)
paracetamol-pethidine
Intervention Description
100 ml containing 1000 mg paracetamol -50 mg pethidine HCL
Primary Outcome Measure Information:
Title
change of the intensity of perceived labor pain.
Description
Labour pain was semi-objectively assessed using the visual analogue scale (VAS). In this technique, the patient is shown a ten cm line which represent at one end no pain and the other worst pain, and the patient is asked to point on the line where her pain lies. This scale has the added advantage that the pain can be given a numerical value.
Time Frame
immediately after the intervention and up to 3 hours after the intervension
Secondary Outcome Measure Information:
Title
duration of the active phase of the 1st stage of labor
Time Frame
immediately from start of active phase of the 1st stage of labor till the end of first stage
Title
duration of the 2nd stage of labor
Time Frame
immediately from start of second stage till deliver of fetus
Title
need for further analgesia
Time Frame
immediately after the intervention till the end of first stage of labour
Title
maternal dizziness, nausea and/or vomiting
Time Frame
immediately after the intervention till the end of first stage
Title
mode of delivery (vaginal or by caesarian
Time Frame
immediately after the intervention
Title
1- and 5-minutes Apgar scores.
Time Frame
immediately after delivery of the fetus
Title
need for neonatal resuscitation
Time Frame
immediately after delivery of the fetus
Title
need for NICU admission
Time Frame
immediately after delivery of the fetus
Title
Neonatal respiratory distress .
Time Frame
immediately after delivery of the fetus

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primiparous aged 18-35 years, Term live singleton pregnancy, Vertex presentation, Spontaneous onset of labor at term 37-42 weeks gestation, In active phase of of 1st stage of labour (cervix dilatation 3- 4 cm). Exclusion Criteria: Clinical evidence of cephalopelvic disproportion Use of any kind of analgesia prior to study Any medical disorder during pregnancy (liver or kidney impairment) Induction of labor, Intrauterine fetal death Evidence of fetal distress Antenatal diagnosis of congenital malformation Previous history of hypersensitivity to either drug Extremes of age (i.e. below 18 or above 35) Multiple pregnancies Cervical dilatation more than 6 cm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Anter
Organizational Affiliation
Faculty of medicine-Menoufia university-shebin elkom -egypt
Official's Role
Study Director
Facility Information:
Facility Name
Menoufia University hospital
City
Shibīn Al Kawm
State/Province
Menoufia
ZIP/Postal Code
11111
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
33902372
Citation
Anter ME, Abdel Attey Saleh S, Shawkey Allam S, Mohamed Nofal A. Efficacy and safety of intravenous paracetamol in management of labour pains in a low resource setting: a randomized clinical trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6320-6328. doi: 10.1080/14767058.2021.1911995. Epub 2021 Apr 26.
Results Reference
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Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

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