Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

NCT04744727 | Completed DMC

• 1 other identifier: 11/2019OBSGN/27
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  immediately after the intervention and up to 3 hours after the intervension

Secondary Outcomes (9)

• duration of the active phase of the 1st stage of labor

  immediately from start of active phase of the 1st stage of labor till the end of first stage

• duration of the 2nd stage of labor

  immediately from start of second stage till deliver of fetus

• need for further analgesia

  immediately after the intervention till the end of first stage of labour

• maternal dizziness, nausea and/or vomiting

  immediately after the intervention till the end of first stage

• mode of delivery (vaginal or by caesarian

  immediately after the intervention

Study Arms (2)

paracetamol group

ACTIVE COMPARATOR

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 \[roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%\].

Drug: paracetamol-pethidine

pethidine group

ACTIVE COMPARATOR

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 \[roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%\].

Drug: paracetamol-pethidine

Interventions

paracetamol-pethidine DRUG

100 ml containing 1000 mg paracetamol -50 mg pethidine HCL

paracetamol group; pethidine group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University hospital

Shibīn al Kawm, Menoufia, 11111, Egypt

Location

Related Publications (1)

• 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.

  PMID: 33902372 DERIVED

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed Anter

  Faculty of medicine-Menoufia university-shebin elkom -egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of obstetrics and gynecology

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 9, 2021
• Study Start: March 1, 2019
• Primary Completion: March 10, 2020
• Study Completion: May 10, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

EG (1)