| The Safety of Progesterone and 17-Hydroxyprogesterone Caproate Administration for the Prevention of Preterm Birth: An Evidence-Based Assessment. | |
| | |
MedLine Citation:
|
PMID: 22773279 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
|
The safety of supplemental progestin therapy during pregnancy reflects whether an agent exclusively promotes or potentially inhibits progestational cellular functions and whether treatment incites a metabolic derangement or other pathophysiology to initiate rare untoward events. No safety signal has been identified from intravaginal administration of natural progesterone from phase III clinical trials. The Food and Drug Administration has identified a legitimate safety signal regarding second-trimester miscarriage and stillbirth with exposure to 17-hydroxyprogesterone caproate (17-OHPC). Results from recent phase II and III trials in multiples also demonstrates concern with exposure to this synthetic for fetal loss and increased severe respiratory distress in neonates (one study each), as well as repeated significant associations for shorter duration of pregnancy and poorer fetal growth in others. The biological plausibility for 17-OHPC to be associated with adverse outcomes can be suggested from pharmacogenomic observations, ex vivo experimentation, and clinical observations. Further data are needed interrogating the potential for rare fetal or maternal adverse events/safety outcomes with exposure to progestins. Safety concerns should be incorporated into prescribing decisions. |
| | |
Authors:
|
John M O'Brien |
Related Documents
:
|
1290069 - Diagnosis of toxoplasma infection in the pregnant woman and the unborn child: current p... 20028609 - Concurrent nematode infection and pregnancy induce physiological responses that impair ... 7659689 - The natural history of fetal cytomegalovirus infection as assessed by serial ultrasound... 8090389 - Safety of the new quinolones in pregnancy. 18246919 - Infective endocarditis in pregnancy complicated by septic embolization to the cerebellum. 21604069 - Acceptability of prenatal diagnosis by a sample of parents of sickle cell anemia patien... 439089 - Reliability factors of delivery due dates. 7593439 - The free form of insulin-like growth factor i increases in circulation during normal hu... 6635729 - Primary hyperparathyroidism and pregnancy. |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2012-7-6 |
Journal Detail:
|
Title: American journal of perinatology Volume: - ISSN: 1098-8785 ISO Abbreviation: - Publication Date: 2012 Jul |
Date Detail:
|
Created Date: 2012-7-9 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 8405212 Medline TA: Am J Perinatol Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
|
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA. |
Affiliation:
|
Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, University of Kentucky, Lexington, Kentucky. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Concentration and the Second Stage of Labor: Outcomes Associated with the Interactive Metronome.
Next Document: Effect of Clinical and Histological Chorioamnionitis on the Outcome of Preterm Infants.