Department of Medicine, Division of Infectious Diseases, University of Wisconsin-Madison School of Medicine and Public Health, Madison, WI, United States of America.
Department of Medicine, Division of Infectious Diseases, William S. Middleton VA Hospital, Madison, WI, United States of America.
Sorbonne université, hôpital Pitié-Salpêtrière, service d'urologie, assistance publique-hôpitaux de Paris, Paris, France. Electronic address: veronique.phe@aphp.fr.
To describe regional differences in utilization of 17α-hydroxyprogesterone caproate (17-OHP)....
Retrospective cohort study of a large, US commercial managed care plan claims database with pharmacy coverage from 2008 to 2018. Singleton pregnancies with at least one prior spontaneous preterm birth...
Of the 4,514 individuals with an indication for 17-OHP, 580 (12.8%) were prescribed 17-OHP. Regional and state-based differences in 17-OHP utilization were identified; Northeast 15.7%, Midwest 13.7%, ...
While significant regional differences in 17-OHP utilization were demonstrated, 17-OHP utilization remained low despite this cohort having insurance through a US commercial managed care plan. Suboptim...
On April 5, 2023, the US Food and Drug Administration withdrew the approval of 17-alpha hydroxyprogesterone caproate, effective immediately, because of the lack of evidence that it reduces the risk of...
The U.S. Food and Drug Administration has recently withdrawn approval for 17-α hydroxyprogesterone caproate for prevention of recurrent preterm birth, and recent studies have called into question bene...
The effectiveness of 17-hydroxyprogesterone caproate is unclear as trials have provided conflicting results. With the absence of fundamental pharmacologic studies addressing dosing or the relationship...
This study aimed to evaluate the relationship between plasma concentrations of 17-hydroxyprogesterone caproate and preterm birth rates and gestational age at preterm delivery and to assess the safety ...
This study recruited 2 cohorts with previous spontaneous preterm birth; 1 cohort (n=143) was randomly assigned to either 250-mg or 500-mg 17-hydroxyprogesterone caproate, and the other cohort (n=16) w...
There was a dose proportional increase in trough plasma concentrations with the 250-mg (median, 8.6 ng/m; n=66) and 500-mg (median, 16.2 ng/mL; n=55) doses. In 116 compliant participants with blood sa...
In this pharmacodynamic study, trough plasma 17-hydroxyprogesterone caproate concentrations were significantly associated with gestational age at preterm birth but not with the preterm birth rate. Pos...
A history of spontaneous preterm birth (sPTB) is a significant risk factor for recurrence. Intra-muscular-7α-hydroxyprogesterone caproate (17P) has been the preventive treatment of choice until the re...
To determine the benefit of (17P) treatment in preventing reoccurrence of sPTB, by evaluating two presenting symptoms of the first sPTB: premature contractions (PMC) and preterm premature rupture of m...
This retrospective study included 342 women with a previous singleton sPTB followed by a subsequent pregnancy. sPTB were either due to PMC (n = 145) or pPROM (n = 197). During the subsequent pregnancy...
Patients treated with 17P in the subsequent pregnancy had delivered earlier in the previous pregnancy (33.4w vs. 35.3w in the PMC group, and 34.1w vs. 35.7w in the pPROM group, p<0.001). In the follow...
17P might delay preterm delivery in patients with a previous sPTB on an individual level (prolongation of the pregnancy for each patient compared to her previous delivery). Therefore, our results impl...
Randomized trials have found benefits of both vaginal progesterone and 17-alpha-hydroxyprogesterone caproate in the prevention of recurrent preterm birth. A previous meta-analysis directly comparing t...
Searches were performed in MEDLINE, Ovid, Scopus, ClinicalTrials.gov, the International Prospective Register of Systematic Reviews (PROSPERO), SciELO, Embase, and the Cochrane Central Register of Cont...
We included all randomized controlled trials of asymptomatic singleton gestations with previous spontaneous preterm birth that were randomized to prophylactic treatment with either vaginal progesteron...
The primary outcome was preterm birth <34 weeks' gestation. The summary measures were reported as relative risks with 95% confidence intervals....
Seven randomized controlled trials including 1910 patients were included in the meta-analysis. Patients who received vaginal progesterone had a significantly lower rate of preterm birth at <34 weeks (...
Overall, vaginal progesterone was superior to 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth at <34 weeks' gestation in singleton pregnancies with previous spontaneous preter...
The US preterm birth rate varies dramatically by race and ethnicity yet the racial and ethnic representation within studies evaluating 17-hydroxprogesterone caproate (17-P) for preterm birth preventio...
We systematically reviewed US studies published between January 2000 and December 2019. Study participant's race and ethnicity were reported using descriptive statistics then compared to US 2017//2018...
Eighteen studies met the inclusion criteria, 17 studies reported race, 11 studies reported ethnicity, and yet none of the studies followed the NIH criteria. Compared to 2017/2018 US preterm births, th...
More detailed reporting of race and ethnicity is needed in 17-P literature. Black women appear to be well represented while other racial and ethnic groups may be understudied....
The IPOP trial demonstrated a reduced risk of severe small for gestational age among infants born to women with HIV who received weekly intramuscular 17 alpha-hydroxyprogesterone caproate. This second...
Spontaneous preterm birth significantly increases the risk for a recurrent preterm birth. Only a few identifiable clinical risk factors can be referenced in counseling for recurrent preterm birth. Fur...
This study aimed to determine if histologic patterns are associated with recurrent preterm birth among patients with an index spontaneous preterm birth. A secondary objective was to determine if place...
This was a retrospective cohort study at a single institution of women with singleton pregnancies with an index spontaneous preterm birth and a subsequent birth within the same hospital system between...
A total of 352 patients were included. Acute inflammation was the most common histologic type seen among patients with spontaneous preterm birth (44.1%), followed by chronic inflammation (40.9%) and m...
Although acute inflammation was prevalent among spontaneous preterm births, more than half of the spontaneous preterm births were not associated with acute inflammation. Low-grade acute inflammation w...
Makena (17-hydroxyprogesterone caproate) was FDA approved for prevention of recurrent spontaneous preterm birth in 2011 under the accelerated approval pathway but fundamental pharmacokinetic or pharma...
The purpose of this study was to evaluate the dosing regimen for 17-hydroxyprogesterone by analyzing three data sets that evaluated 17-hydroxyprogesterone caproate pharmacology: the Maternal-Fetal Med...
Data from the Omega 3 study were utilized to determine if plasma concentration was related to spontaneous preterm birth risk and if a threshold concentration could be identified. Data from the Obstetr...
Analysis of the Omega 3 dataset indicated that the risk of spontaneous preterm birth decreased as the log of 17-hydroxyprogesterone caproate increased [odds ratio (95%CI) 0.04 (0.00 - 0.90)]. A steady...
The dosing regimen for 17-hydoxyprogesterone caproate was inadequate. There is a significant inverse relationship between drug concentration and spontaneous preterm birth. Risk is lowest when concentr...
