Clinical trial NCT04744727: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: change of the intensity of perceived labor pain.
timeFrame: immediately after the intervention and up to 3 hours after the intervension
Secondary outcomes:
measure: duration of the active phase of the 1st stage of labor
timeFrame: immediately from start of active phase of the 1st stage of labor till the end of first stage
measure: duration of the 2nd stage of labor
timeFrame: immediately from start of second stage till deliver of fetus
measure: need for further analgesia
timeFrame: immediately after the intervention till the end of first stage of labour
measure: maternal dizziness, nausea and/or vomiting
timeFrame: immediately after the intervention till the end of first stage
measure: mode of delivery (vaginal or by caesarian
timeFrame: immediately after the intervention
measure: 1- and 5-minutes Apgar scores.
timeFrame: immediately after delivery of the fetus
measure: need for neonatal resuscitation
timeFrame: immediately after delivery of the fetus
measure: need for NICU admission
timeFrame: immediately after delivery of the fetus
measure: Neonatal respiratory distress .
timeFrame: immediately after delivery of the fetus
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University hospital
state: Menoufia
Study officials:
affiliation: Faculty of medicine-Menoufia university-shebin elkom -egypt
name: Mohamed Anter
role: STUDY_DIRECTOR
References:
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.