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Completed

NCT Number: NCT04744727

Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paracetamol-pethidine

Drug

100 ml containing 1000 mg paracetamol -50 mg pethidine HCL

Primary outcomes

  1. change of the intensity of perceived labor pain.

    Time frame: immediately after the intervention and up to 3 hours after the intervension

    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 outcomes

  1. 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

  2. duration of the 2nd stage of labor

    Time frame: immediately from start of second stage till deliver of fetus

  3. need for further analgesia

    Time frame: immediately after the intervention till the end of first stage of labour

  4. maternal dizziness, nausea and/or vomiting

    Time frame: immediately after the intervention till the end of first stage

  5. mode of delivery (vaginal or by caesarian

    Time frame: immediately after the intervention

  6. 1- and 5-minutes Apgar scores.

    Time frame: immediately after delivery of the fetus

  7. need for neonatal resuscitation

    Time frame: immediately after delivery of the fetus

  8. need for NICU admission

    Time frame: immediately after delivery of the fetus

  9. Neonatal respiratory distress .

    Time frame: immediately after delivery of the fetus

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain in a Low Resource Setting

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 9, 2021
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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