Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor

NCT01428375

Labor Pain

COMPLETED PHASE3

Analgesic Effects of Intravenous Paracetamol on Labor Pain

NCT01394731

Labor Pain

COMPLETED PHASE4

Patient Controlled Remifentanil Analgesia for Normal Labour

NCT04541719

Labor Pain Full Term Pregnancy

WITHDRAWN PHASE2

Labor Induction and Pain Relief With Paracetamol Versus Placebo

NCT05097950

Labor Pain

COMPLETED NA

Hyoscine ButylBromide for Intrapartum Analgesia

NCT02557087

Analgesia, Obstetrical

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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 Type ACTIVE_COMPARATOR

paracetamol-pethidine

Intervention Type DRUG

100 ml containing 1000 mg paracetamol -50 mg pethidine HCL

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

Group Type ACTIVE_COMPARATOR

paracetamol-pethidine

Intervention Type DRUG

100 ml containing 1000 mg paracetamol -50 mg pethidine HCL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

paracetamol-pethidine

100 ml containing 1000 mg paracetamol -50 mg pethidine HCL

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes