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Replication of clinical associations with 17-hydroxyprogesterone in preterm newborns.

ABSTRACT: Nationally, newborn screening programs use 17-hydroxyprogesterone (17-OHP) as the biomarker to detect the rare but potentially fatal inherited disease, congenital adrenal hyperplasia. However, this biomarker is highly variable, with a high false-positive rate of detection, particularly in neonates born preterm. Several studies have examined various clinical and genetic factors to explain the variability of 17-OHP in preterm infants. The purpose of this study was to replicate previous clinical and genetic associations with 17-OHP in a well-characterized cohort of 762 preterm infants. We replicated previous findings that respiratory distress syndrome (p = 2 x 10(-3)) is associated with higher 17-OHP. Higher 17-OHP and false positives were significantly associated with lower gestational age and birth weight, as previously reported. Incorporating gestational age and birth weight together decreases the false-positive rate.

SUBMITTER: Ryckman KK

PROVIDER: S-EPMC3552557 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature

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Replication of clinical associations with 17-hydroxyprogesterone in preterm newborns.

Ryckman Kelli K KK Cook Daniel E DE Berberich Stanton L SL Shchelochkov Oleg A OA Berends Susan K SK Busch Tamara T Dagle John M JM Murray Jeffrey C JC

Journal of pediatric endocrinology & metabolism : JPEM 20120101 3-4

Nationally, newborn screening programs use 17-hydroxyprogesterone (17-OHP) as the biomarker to detect the rare but potentially fatal inherited disease, congenital adrenal hyperplasia. However, this biomarker is highly variable, with a high false-positive rate of detection, particularly in neonates born preterm. Several studies have examined various clinical and genetic factors to explain the variability of 17-OHP in preterm infants. The purpose of this study was to replicate previous clinical an ...[more]

PMID: 22768660

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Project description:BackgroundA 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 recent "Prolong study" that reported no benefit.ObjectiveTo 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 membranes (pPROM).Study designThis 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, 90 (26.3%) patients received 250 mg 17P IM. Each presenting symptom-PMC or pPROM-was evaluated within itself comparing treated vs. untreated groups. Data were analyzed using t-test, Chi-square and Fisher's exact test. Logistic regression analysis was also performed.ResultsPatients 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 following pregnancy, they had higher admission rates due to suspected preterm labor (31.7% vs. 10.9% in the treated vs. untreated PMC group (p = 0.003) and 26.1% vs. 5.4% in the treated vs. untreated pPROM group (p<0.001). In both groups, but more prominently in the previous PMC group, treatment compared to non-treatment in the subsequent pregnancy significantly prolonged it (4.3w vs. 2.6w in the PMC group (p = 0.007), and 3.7w vs. 2.7w in the pPROM group (p = 0.018)). The presenting symptom of sPTB in the following pregnancy tended to recur in cases of another sPTB, with a significantly greater likelihood of repeating the sPTB mechanism in cases with PMC, regardless of receiving 17P (69% in the PMC cohort and 60% in the pPROM cohort, p<0.001).Conclusions17P 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 imply that 17P can decrease potential premature delivery complications for patients with a previous sPTB due to PMC or pPROM.

Project description:Background17-alpha Hydroxyprogesterone caproate for prevention of recurrent preterm birth is recommended for use in the United States.ObjectiveWe sought to assess the clinical effectiveness of 17-alpha hydroxyprogesterone caproate to prevent recurrent preterm birth ≤35 weeks compared to similar births in our obstetric population prior to the implementation of 17-alpha hydroxyprogesterone caproate.Study designThis was a prospective cohort study of 17-alpha hydroxyprogesterone caproate in our obstetric population. The primary outcome was the recurrence of birth ≤35 weeks for the entire study cohort compared to a historical referent rate of 16.8% of recurrent preterm birth in our population. There were 3 secondary outcomes. First, did 17-alpha hydroxyprogesterone caproate modify a woman's history of preterm birth when taking into account her prior number and sequence of preterm and term births? Second, was recurrence of preterm birth related to 17-alpha hydroxyprogesterone caproate plasma concentration? Third, was duration of pregnancy modified by 17-alpha hydroxyprogesterone caproate treatment compared to a prior preterm birth?ResultsFrom January 2012 through March 2016, 430 consecutive women with prior births ≤35 weeks were treated with 17-alpha hydroxyprogesterone caproate. Nearly two thirds of the women (N = 267) began injections ≤18 weeks and 394 (92%) received a scheduled weekly injection within 10 days of reaching 35 weeks or delivery. The overall rate of recurrent preterm birth was 25% (N = 106) for the entire cohort compared to the 16.8% expected rate (P = 1.0). The 3 secondary outcomes were also negative. First, 17-alpha hydroxyprogesterone caproate did not significantly reduce the rates of recurrence regardless of prior preterm birth number or sequence. Second, plasma concentrations of 17-alpha hydroxyprogesterone caproate were not different (P = .17 at 24 weeks; P = .38 at 32 weeks) between women delivered ≤35 weeks and those delivered later in pregnancy. Third, the mean (±SD) interval in weeks of recurrent preterm birth before 17-alpha hydroxyprogesterone caproate use was 0.4 ± 5.3 weeks and the interval of recurrent preterm birth after 17-alpha hydroxyprogesterone caproate treatment was 0.1 ± 4.7 weeks (P = .63). A side effect of weekly 17-alpha hydroxyprogesterone caproate injections was an increase in gestational diabetes. Specifically, the rate of gestational diabetes was 13.4% in 17-alpha hydroxyprogesterone caproate-treated women compared to 8% in case-matched controls (P = .001).Conclusion17-alpha Hydroxyprogesterone caproate was ineffective for prevention of recurrent preterm birth and was associated with an increased rate of gestational diabetes.

Dataset Information

Replication of clinical associations with 17-hydroxyprogesterone in preterm newborns.

Publications

Replication of clinical associations with 17-hydroxyprogesterone in preterm newborns.

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