Pregnant women expected to deliver between 24 and 30 weeks' gestation MedDRA version: 20.0 Level: LLT Classification code 10033762 Term: Paracetamol System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Paracetamol Fresenius Kabi RVG 10 mg/ml oplossing voor infusie
Pharmaceutical Form: Concentrate for solution for injection/infusion
Sponsors
Leiden University Medical Centre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Pregnant women expected to deliver between 24+0-29+6 weeks’ gestation and admitted to the LUMC. - Informed consent from caregiver(s) (see 10.2). Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Fetuses with congenital anomalies affecting the heart, lungs, kidneys or liver. - Pregnant women in whom the use of acetaminophen is contraindicated for any reason, consisting of: severe renal impairment, severe hepatic impairment, severe active liver disease (including HELLP-syndrome), a known alcohol addiction and a known hypersensitivity to acetaminophen or to any of the excipients in the intravenous formulation. - Pregnant women that use one of the following medication: probenecid, salicylamide, rifampicin, isoniazid, barbiturates, tricyclic antidepressants, anti-epileptic medication, zidovudine, oral coagulants, metoclopramide, domperidone, colestyramine and imatinib. - Acetaminophen administration required for standard care within 4 hours prior to birth. - Decision to give palliative care to the neonate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the feasibility of antenatal paracetamol administration to pregnant women 0.5-2 hours prior to birth.;Secondary Objective: The secondary objective of this study is to compare the effect of antenatal acetaminophen administration to standard care on breathing effort, which is expressed as minute volume of spontaneous breathing in the first 1-5 minutes after birth, of premature infants at birth.;Primary end point(s): The primary study outcome is the feasibility, expressed as the success rate, n (%), of pregnant women in the intervention group receiving acetaminophen 0.5-2 hours prior to birth. ;Timepoint(s) of evaluation of this end point: The primary endpoint is evaluated directly after birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary study outcome is breathing effort, expressed as average minute volume (mL/kg/min, continuous) in the first 1-5 minutes after birth, calculated using measured tidal volume of spontaneous breaths on CPAP (mL/kg/breath, continuous) and respiratory rate independent of respiratory support (breaths/min, continuous), and assessed by a respiratory function monitor used for respiratory support at birth in the LUMC (Advanced Life Diagnostics, Weener, Germany). .;Timepoint(s) of evaluation of this end point: During the time interval 1-5 minutes after birth. | — |
Countries
Netherlands
Contacts
Public ContactResearcher overseeing project
Leiden University Medical Center
Outcome results
None listed