Evidence map›Paper›PMID 26452328›Full record

ArticleContraception2016

Clotting factor changes during the first cycle of oral contraceptive use.

Carolyn L Westhoff, Andrew Eisenberger, Rosalind Tang, Serge Cremers, Lisa V Grossman, Malcolm C Pike

Open access · greenAbstract read
In one paragraph

Article in Contraception, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% of its field
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 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Article
  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

6 authors at 2 institutions in 1 country.

Carolyn L WesthoffDepartment of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY 10032, USA; Department of Epidemiology, Columbia University Medical Center, New York, NY 10032, USA. Electronic address: clw3@columbia.edu.
Andrew EisenbergerDepartment of Medicine, Columbia University Medical Center, New York, NY 10032, USA.
Rosalind TangDepartment of Obstetrics and Gynecology, Columbia University Medical Center, New York, NY 10032, USA.
Serge CremersDepartment of Pathology and Cell Biology, Columbia University Medical Center, New York, NY 10032, USA.
Lisa V GrossmanDepartment of Epidemiology, Columbia University Medical Center, New York, NY 10032, USA.
Malcolm C PikeDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.
Columbia University Irving Medical Center · USMemorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024156 · NCRR · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2006 to 2011
$53.0M
Clinical and Translational Science AwardUL1TR000040 · NCATS · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GINSBERG, HENRY N · 2012 to 2015
$26.2M
NCATS NIH HHS UL1 TR000040NCI NIH HHS P30 CA008748NCRR NIH HHS UL1 RR024156
6 · The paper itself

Abstract

objectivesThe risk of venous thromboembolism (VTE) is highest during the initial months of oral contraceptive (OC) use. We sought to evaluate the extent of hemostatic variable changes during the initial OC cycle and if such changes are related to systemic ethinyl estradiol (EE2) exposure. STUDY

designParticipants provided multiple blood samples during a 21-day OC cycle (30mcg EE2; 150mcg levonorgestrel) and after a single dose following a washout period. Analytes included D-dimer, factor VIII activity, protein C total antigen and the hepatic proteins corticosteroid-binding globulin (CBG) and sex-hormone-binding globulin (SHBG). EE2 pharmacokinetic analyses related to the 24h after the first OC tablet (OC1) and at steady state (OC21).

resultsSeventeen women completed the study. D-dimer more than doubled by OC6 (p=.013) and remained elevated at OC21 (p=.012). D-dimer levels within women varied widely from day to day. Factor VIII increased 27% by OC2 (p<.001) but declined to a 9% increase by OC21. Protein C increased only 6%. EE2 steady-state area-under-the-curve ranged from 488 to 1103pg∙h/mL; higher levels were not correlated with greater increases in clotting variables. CBG and SHBG increased significantly but were not significantly correlated with levels of EE2 or with the hemostatic variables.

conclusionsD-dimer increases during the first OC cycle were at least as great as increases seen with longer OC use. These results provide support for the increased VTE risk during initial OC use. The extreme variability in D-dimer levels may be an important component of this risk. IMPLICATIONS: This study showed that increases in D-dimer are clearly evident in the first cycle of OC use and may be larger than are seen after a longer duration of use and thus provide biological support for the increased VTE risk during initial OC use found in epidemiological studies.

Indexed as

AdultContraceptives, Oral, SyntheticEstrogensEthinyl EstradiolFactor VIIIFemaleFibrin Fibrinogen Degradation ProductsHumansLevonorgestrelPilot ProjectsProtein CSex Hormone-Binding GlobulinTranscortinYoung AdultContraceptives, Oral, SyntheticEstrogensEthinyl EstradiolFactor VIIIFibrin Fibrinogen Degradation Productsfibrin fragment DLevonorgestrelProtein CSex Hormone-Binding GlobulinTranscortinD-dimerFactor VIIIOral contraceptivesProtein CVenous thromboembolism

Identifiers

PMID26452328
PMCPMC5004596
OpenAlexW2210075417

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.