Evidence map›Paper›PMID 27133963›Full record

ArticleBritish journal of clinical pharmacology2016

Population pharmacokinetics of 17α-hydroxyprogesterone caproate in singleton gestation.

Shringi Sharma, Steve Caritis, Gary Hankins, Menachem Miodovnik, Mary F Hebert, Don Mattison, Raman Venkataramanan

Abstract read
In one paragraph

Article in British journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Shringi SharmaDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA. shringisharma@yahoo.com.
Steve CaritisDepartments of Obstetrics, Gynecology and Reproductive Sciences, Magee-Women's Hospital, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Gary HankinsDepartment of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, TX, USA.
Menachem MiodovnikMedstar Health Research Institute, Hyatsville, MD, USA.
Mary F HebertDepartment of Pharmacy and Obstetrics & Gynecology, University of Washington, Seattle, WA, USA.
Don MattisonMcLaughlin Centre for Population Health Risk Assessment, University of Ottawa, and Risk Sciences International, Ottawa, ON, Canada.
Raman VenkataramananDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA.

Funding

Pregnancy and Drug Metabolizing Enzymes and TransportersU10HD047905 · NICHD · MAGEE-WOMEN'S RES INST AND FOUNDATION · PI CARITIS, STEVE N · 2004 to 2014
$9.7M
UW Obstetric-Fetal Pharmacology Research UnitU10HD047892 · NICHD · UNIVERSITY OF WASHINGTON · PI EASTERLING, THOMAS R, HEBERT, MARY F · 2004 to 2014
$9.4M
NICHD NIH HHS U10 HD047892NICHD NIH HHS U10 HD047905
6 · The paper itself

Abstract

aims17α-hydroxyprogesterone caproate (17-OHPC) reduces the rate of preterm birth in women with a prior preterm birth. Limited data exist on the pharmacokinetics (PK) of 17-OHPC or the plasma concentrations achieved during therapy. In this study, we evaluated the population PK of 17-OHPC in pregnant subjects with singleton gestation and also evaluated intrinsic and extrinsic factors that may potentially affect 17-OHPC PK in this patient population.

methodsSixty-one women with singleton pregnancies participated in this trial. Subjects received weekly intramuscular injections of 250 mg 17-OHPC in 1 ml castor oil from the time of enrolment (16 0/7 weeks - 20 6/7 weeks) up to 35 weeks gestation or until delivery. Blood samples were obtained between 24 and 28 weeks, between 32 and 35 weeks and over a 28-day period beyond the last injection. Maternal and/or cord blood were obtained at delivery. Data analysis was performed by nonlinear mixed effects modelling (NONMEM(®) ).

resultsThe 17-OHPC PK were best described by a model with one maternal compartment and one fetal compartment, with first-order absorption and elimination from the maternal compartment. Maternal body weight was a significant covariate for both clearance (CL/F) and volume of distribution (Vmaternal /F). The final population mean estimates were: CL/F 1797 l/d, Vmaternal /F 32 610 l and mother to cord rate constant 0.005 day(-1) . This report describes for the first time the population PK of 17-OHPC in singleton pregnancy.

conclusionsThe population PK study reported here represents the initial steps in understanding and optimizing 17-OHPC therapy for preventing preterm birth.

Indexed as

17 alpha-Hydroxyprogesterone CaproateAdultBody WeightFemaleFetal BloodHumansHydroxyprogesteronesModels, BiologicalPregnancyYoung Adult17 alpha-Hydroxyprogesterone CaproateHydroxyprogesterones17α-hydroxyprogesterone caproatepopulation pharmacokineticspreterm birth

Identifiers

PMID27133963
PMCPMC5137834

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.