Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Disposition of Intravenous Paracetamol in Young Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02590900
Recruitment Status : Completed
First Posted : October 29, 2015
Last Update Posted : October 29, 2015
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

Compared to early postpartum (10-15 weeks) observations, paracetamol clearance was significantly higher (21.1 vs 11.7 l.h-1, + 80 %) at delivery. This higher clearance was due to a disproportional increase in glucuronidation (11.6 vs 4.76 l.h-1, + 144 %), a proportional increase in oxidation clearance (4.95 vs 2.77 l.h-1, 78 %) and primary renal clearance (1.15 vs 0.75 l.h-1, 53 %) [KUlo et al, Int J Obstet Anesth]. This increase in glucuronidation clearance may in part be driven by oestradiol, and may explain within and between individual differences in paracetamol metabolism (e.g. oral contraceptives, follicular vs luteal phase, postpartum, pregnancy, or duration of pregnancy) in young women.

Based on a pooled analysis, investigators aimed to further explore the impact of these covariates on paracetamol metabolism based on plasma and urine collections in women at delivery, in postpartum (early, or late) and healthy volunteers, either or not on oral contraceptives (OC) following intravenous (iv) paracetamol administration.


Condition or disease Intervention/treatment
Pain Drug: intravenous paracetamol (acetaminophen)

Detailed Description:

This study aims to perform a pooled analysis of:

  1. Paracetamol PK data recently published in 47 pregnant women. In these cases, iv paracetamol was administered q6h after delivery (caesarean) for 24 h. 8 were recruited a second time for an additional single dose pK study in postpartum (Kulo et al, Br J Clin Pharmacol 2013).
  2. The PK data as initially published by Gregoire et al, but limited to female volunteers, all on oral contraceptives (n=14) (Gregoire et al, Clin Pharm Ther 2007)
  3. A dataset in 8 young women not on oral contraceptives, iv paracetamol, single dose.

Layout table for study information
Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Disposition of Intravenous Paracetamol in Young Women, Including During Pregnancy, in Postpartum or When on Oral Contraceptives
Study Start Date : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Group/Cohort Intervention/treatment
at delivery
women who underwent cesarean at delivery, and needed iv paracetamol as part of multimodal analgesia. In these cases, paracetamol was administered q6h (2g loading dose, 1g q6h for 24 h), and blood and urine samples were collected to describe paracetamol disposition at delivery.
Drug: intravenous paracetamol (acetaminophen)
paracetamol disposition in young women, exploring the impact of covariates (pregnancy, postpartum, oral contraceptives) in this population.
Other Name: Perfusalgan, paracetamol Fresenius,

postpartum
a subgroup of 8 women initially included in at delivery, underwent a second PK study 2-3 months postpartum and another PK study about 1 year after delivery. This PK study was based on a single iv paracetamol administration (2 g), and blood and urine samples were collected to describe paracetamol disposition in postpartum
Drug: intravenous paracetamol (acetaminophen)
paracetamol disposition in young women, exploring the impact of covariates (pregnancy, postpartum, oral contraceptives) in this population.
Other Name: Perfusalgan, paracetamol Fresenius,

healthy female volunteers

a group of 8 young healthy women not on oral contraceptives underwent a single PK study (2 g intravenous paracetamol) and blood and urine samples were collected to described paracetamol disposition in healthy female volunteers, not on oral contraceptives.

Raw data as published by Gregoire et al (Clin Pharm Ther 2007) were available in 14 young women, all on contraceptives.

Drug: intravenous paracetamol (acetaminophen)
paracetamol disposition in young women, exploring the impact of covariates (pregnancy, postpartum, oral contraceptives) in this population.
Other Name: Perfusalgan, paracetamol Fresenius,




Primary Outcome Measures :
  1. paracetamol disposition in young women: total clearance and metabolite specific clearance estimates [ Time Frame: 24 h is the maximal time frame of this pharmacokinetic study (PK is the outcome measured ]
    pooled analysis of plasma and urine paracetamol and paracetamol metabolite data published in literature in young women following iv paracetamol administration. Samples (plasma and urine) will be collected in the 24 h time interval after initiation of intravenous paracetamol administration (time interval of the PK study)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pooled analysis of different cohorts of young women who all underwent PK study on paracetamol disposition after iv paracetamol administration.
Criteria

Inclusion Criteria:

  1. informed consent
  2. for patients (pregnant women at delivery), there has to be a clinical indication (post caesarean analgesia, NPO) to administer iv paracetamol.

Exclusion Criteria:

  1. intolerance to paracetamol
  2. withdrawal of informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590900


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Layout table for investigator information
Principal Investigator: karel allegaert, MD, PhD Universitaire Ziekenhuizen Leuven

Publications of Results:
Layout table for additonal information
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02590900    
Other Study ID Numbers: ML6563
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015
Keywords provided by Universitaire Ziekenhuizen Leuven:
pharmacokinetics
pregnancy
oral contraceptives
oestradiol
Additional relevant MeSH terms:
Layout table for MeSH terms
Acetaminophen
Contraceptive Agents
Contraceptives, Oral
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Reproductive Control Agents
Contraceptive Agents, Female