Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

2021 ◽  
pp. 38-42
Author(s):  
Emily A. Oliver ◽  
Amanda Roman-Camargo
Keyword(s):  
Preterm Birth ◽  
Child Health ◽  
Human Development ◽  
Intraventricular Hemorrhage ◽  
Controlled Trial ◽  
Supplemental Oxygen ◽  
Spontaneous Preterm Birth ◽  
Increased Risk ◽  
Hydroxyprogesterone Caproate ◽  
History Of

Women with a history of spontaneous preterm birth have an increased risk of recurrent preterm birth. In this randomized placebo-controlled trial funded by the National Institute of Child Health and Human Development, patients between 16 and 20 weeks of gestation with a history of spontaneous preterm birth were administered intramuscular 17 alpha-hydroxyprogesterone caproate (17P) or placebo, weekly until 36 weeks of gestation. Treatment with 17P significantly reduced the rate of preterm birth (36.3% vs. 54.9%, p <0.001). Rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen were all significantly decreased in the 17P group. In women with a history of spontaneous preterm birth, weekly 17P decreases the rate of recurrent preterm birth.

scholarly journals Impact of Obesity on the Rate of Recurrent Spontaneous Preterm Birth in Women Treated with 17-alpha Hydroxyprogesterone Caproate

2018 ◽  
Vol 35 (09) ◽  
pp. 809-814 ◽  
Author(s):  
Lara Lemon ◽  
Allison Serra ◽  
Shringi Sharma ◽  
Raman Venkataramanan ◽  
Steve Caritis ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Pharmacokinetic Studies ◽  
Maternal Body Mass Index ◽  
Omega 3 ◽  
Spontaneous Preterm Birth ◽  
Obesity Class ◽  
Hydroxyprogesterone Caproate ◽  
The Impact

Objective We sought to determine if the rate of recurrent spontaneous preterm birth (PTB) in women treated with 17-α hydroxyprogesterone caproate (17-OHPC) is modified by maternal body mass index (BMI). Study Design We performed a secondary analysis of the Maternal-Fetal Medicine Units Network omega-3 fatty acid supplementation to prevent recurrent PTB randomized controlled trial. All women received 17-OHPC. Results A total of 708 women were included. Rates of spontaneous PTB did not vary significantly by BMI category. With stratification by obesity class and gestational age at delivery, the unadjusted risk for PTB using earlier gestational cutoffs (< 35, 32, and 28 weeks) demonstrated an association between preterm delivery and increasing severity of obesity. With adjustment for potential confounders, there was no statistically significant relationship between BMI and spontaneous PTB. Conclusion We demonstrated that the risk of PTB in women receiving 250 mg 17-OHPC is not dependent on maternal BMI after adjustment for confounding variables. Pharmacokinetic studies have demonstrated a wide variation in plasma concentration of 17-OHPC across the population with likely considerable overlap in plasma concentrations among the obese and nonobese population. Further studies are needed to evaluate the impact of BMI on efficacy of 17-OHPC prior to any dose adjustment in this population.

scholarly journals Safety review of hydroxyprogesterone caproate in women with a history of spontaneous preterm birth

2020 ◽  
Author(s):  
Baha Sibai ◽  
George R. Saade ◽  
Anita F. Das ◽  
Jennifer Gudeman
Keyword(s):  
Preterm Birth ◽  
Gestational Diabetes ◽  
Neonatal Death ◽  
Safety Data ◽  
Spontaneous Preterm Birth ◽  
Relative Risks ◽  
Hydroxyprogesterone Caproate ◽  
History Of ◽  
Favorable Safety ◽  
Confirmatory Trial

Abstract 17-alpha-hydroxyprogesterone caproate (17P) has been in use for prevention of recurrent preterm birth since 2003 when the Meis trial was published. A requirement for Food and Drug Administration approval of 17P was a confirmatory trial, called “PROLONG”, which was recently completed, but did not replicate the efficacy demonstrated in the Meis trial. This review analyzes the safety data from each trial, as well as integrated data from the two trials. The relative risks (95% CI) with 17P versus placebo in the integrated dataset were 0.66 (0.25–1.78) for miscarriage, 1.83 (0.68–4.91) for stillbirth, and 0.86 (0.53–1.41) for all fetal and neonatal death. The rate of gestational diabetes in the integrated dataset was 3.6% for 17P vs. 3.8% for placebo. Similar findings with low and comparable rates between 17P and placebo were also found for other adverse events. The integrated safety data demonstrate a favorable safety profile that was comparable to placebo.

scholarly journals 929: Characteristics of women not receiving treatment with 17-alpha-hydroxyprogesterone-caproate for a history of spontaneous preterm birth

2020 ◽  
Vol 222 (1) ◽  
pp. S574-S575
Author(s):  
Katherine Massa ◽  
Megan L. Lawlor ◽  
Ashley Boerrigter ◽  
Laura K. Vricella ◽  
Katherine S. Childress
Keyword(s):  
Preterm Birth ◽  
Spontaneous Preterm Birth ◽  
Hydroxyprogesterone Caproate ◽  
History Of

scholarly journals CRAFT (Cerclage after full dilatation caesarean section): protocol of a mixed methods study investigating the role of previous in-labour caesarean section in preterm birth risk

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Naomi Carlisle ◽  
Agnieszka Glazewska-Hallin ◽  
Lisa Story ◽  
Jenny Carter ◽  
Paul T. Seed ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Caesarean Section ◽  
Controlled Trial ◽  
Transvaginal Ultrasound ◽  
Subsequent Pregnancy ◽  
Spontaneous Preterm Birth ◽  
Short Cervix ◽  
Fetal Fibronectin ◽  
Increased Risk ◽  
Late Miscarriage

Abstract Background Full dilatation caesarean sections are associated with recurrent early spontaneous preterm birth and late miscarriage. The risk following first stage caesarean sections, are less well defined, but appears to be increased in late-first stage of labour. The mechanism for this increased risk of late miscarriage and early spontaneous preterm birth in these women is unknown and there are uncertainties with regards to clinical management. Current predictive models of preterm birth (based on transvaginal ultrasound and quantitative fetal fibronectin) have not been validated in these women and it is unknown whether the threshold to define a short cervix (≤25 mm) is reliable in predicting the risk of preterm birth. In addition the efficacy of standard treatments or whether benefit may be derived from prophylactic interventions such as a cervical cerclage is unknown. Methods There are three distinct components to the CRAFT project (CRAFT-OBS, CRAFT-RCT and CRAFT-IMG). CRAFT-OBS: Observational Study; To evaluate subsequent pregnancy risk of preterm birth in women with a prior caesarean section in established labour. This prospective study of cervical length and quantitative fetal fibronectin data will establish a predictive model of preterm birth. CRAFT-RCT: Randomised controlled trial arm; To assess treatment for short cervix in women at high risk of preterm birth following a fully dilated caesarean section. CRAFT-IMG: Imaging sub-study; To evaluate the use of MRI and transvaginal ultrasound imaging of micro and macrostructural cervical features which may predispose to preterm birth in women with a previous fully dilated caesarean section, such as scar position and niche. Discussion The CRAFT project will quantify the risk of preterm birth or late miscarriage in women with previous in-labour caesarean section, define the best management and shed light on pathological mechanisms so as to improve the care we offer to women and their babies. Trial registration CRAFT was prospectively registered on 25th November 2019 with the ISRCTN registry (10.1186/ISRCTN15068651).

Factors Associated with Utilization of 17-Hydroxyprogesterone Caproate for the Prevention of Recurrent Preterm Birth

2019 ◽  
Vol 37 (03) ◽  
pp. 264-270 ◽  
Author(s):  
Anna E. DeNoble ◽  
Clara E. Wynn ◽  
Kristin E. Weaver ◽  
Sarahn M. Wheeler ◽  
Geeta K. Swamy
Keyword(s):  
Preterm Birth ◽  
Prenatal Care ◽  
Stepwise Logistic Regression ◽  
Spontaneous Preterm Birth ◽  
Hispanic Ethnicity ◽  
Factors Associated ◽  
Hydroxyprogesterone Caproate ◽  
History Of ◽  
Term Births ◽  
17 Hydroxyprogesterone

Objective Weekly 17-hydroxyprogesterone caproate (17OHP-C) from 16 to 36 weeks' gestation reduces the risk of recurrent spontaneous preterm birth (sPTB). Limited data suggest poor adherence to published guidelines. This study aimed to identify factors associated with 17OHP-C utilization. Study Design This retrospective cohort study included women with a singleton pregnancy who delivered within one academic health system between January 2014 and December 2015. Eligible women had a history of ≥1 singleton sPTB. Primary outcomes were counseling about, receipt of, and adherence to 17OHP-C therapy. Demographic and clinical predictors of the primary outcomes were determined using stepwise logistic regression. Results Of 410 eligible subjects, 69% (N = 284) were counseled about and 36% (N = 148) received 17OHP-C. Hispanic ethnicity, delay in prenatal care initiation, and a history of prior term births were associated with lower odds of 17OHP-C counseling. Each week delay in prenatal care initiation, Hispanic ethnicity, and each additional week's gestation of the earliest prior sPTB decreased the odds of receiving 17OHP-C. Maternal age and prior term births were associated with adherence. Conclusion Utilization of evidence-based 17OHP-C therapy remains suboptimal: cultural and access-to-care barriers for eligible women may impede efforts to decrease recurrent sPTB rates.

Women with high plasma levels of PBDE-47 are at increased risk of preterm birth

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Morgan R. Peltier ◽  
Michael J. Fassett ◽  
Yuko Arita ◽  
Vicki Y. Chiu ◽  
Jiaxiao M. Shi ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Los Angeles ◽  
Polybrominated Diphenyl Ethers ◽  
Flame Retardants ◽  
Plasma Concentrations ◽  
First Trimester ◽  
High Plasma ◽  
Thyroid Stimulating Hormone ◽  
Spontaneous Preterm Birth ◽  
Increased Risk

Abstract Objectives Nearly 100% of North American women have detectable levels of flame retardants such as polybrominated diphenyl ethers (PBDEs) in their plasma. These molecules have structural homology to thyroid hormones and may function as endocrine disruptors. Thyroid dysfunction has previously been associated with increased risk for preterm birth. Therefore, we conducted a multi-center, case-cohort study to evaluate if high plasma concentrations of a common PBDE congener in the first trimester increases the risk of preterm birth and its subtypes. Methods Pregnant women were recruited at the onset of initiation of prenatal care at Kaiser-Permanente Southern California (KPSC)-West Los Angeles and KPSC-San Diego medical centers. Plasma samples from women whose pregnancies ended preterm and random subset of those delivering at term were assayed for PBDE-47 and thyroid-stimulating hormone (TSH) by immunoassay. Quartile cutoffs were calculated for the patients at term and used to determine if women with exposures in the 4th quartile are at increased risk for preterm birth using logistic regression. Results We found that high concentrations of PBDE-47 in the first trimester significantly increased the odds of both indicated (adjusted odds ratio, adjOR=2.35, 95% confidence interval [CI]: 1.31, 4.21) and spontaneous (adjOR=1.76, 95% CI: 1.02, 3.03) preterm birth. Regardless of pregnancy outcome, TSH concentrations did not differ between women with high and low concentrations of PBDE-47. Conclusions These results suggest that high plasma concentrations of PBDE-47 in the first trimester, increases the risk of indicated and spontaneous preterm birth.

scholarly journals An observational claims data analysis on the risk of maternal chronic kidney disease after preterm delivery and preeclampsia

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Maren Goetz ◽  
Mitho Müller ◽  
Raphael Gutsfeld ◽  
Tjeerd Dijkstra ◽  
Kathrin Hassdenteufel ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Preterm Birth ◽  
Kidney Disease ◽  
Preterm Delivery ◽  
Claims Data ◽  
Maternal Risk ◽  
Live Births ◽  
Increased Risk ◽  
History Of

AbstractWomen with complications of pregnancy such as preeclampsia and preterm birth are at risk for adverse long-term outcomes, including an increased future risk of chronic kidney disease (CKD) and end-stage kidney disease (ESKD). This observational cohort study aimed to examine the risk of CKD after preterm delivery and preeclampsia in a large obstetric cohort in Germany, taking into account preexisting comorbidities, potential confounders, and the severity of CKD. Statutory claims data of the AOK Baden-Wuerttemberg were used to identify women with singleton live births between 2010 and 2017. Women with preexisting conditions including CKD, ESKD, and kidney replacement therapy (KRT) were excluded. Preterm delivery (< 37 gestational weeks) was the main exposure of interest; preeclampsia was investigated as secondary exposure. The main outcome was a newly recorded diagnosis of CKD in the claims database. Data were analyzed using Cox proportional hazard regression models. The time-dependent occurrence of CKD was analyzed for four strata, i.e., births with (i) neither an exposure of preterm delivery nor an exposure of preeclampsia, (ii) no exposure of preterm delivery but exposure of at least one preeclampsia, (iii) an exposure of at least one preterm delivery but no exposure of preeclampsia, or (iv) joint exposure of preterm delivery and preeclampsia. Risk stratification also included different CKD stages. Adjustments were made for confounding factors, such as maternal age, diabetes, obesity, and dyslipidemia. The cohort consisted of 193,152 women with 257,481 singleton live births. Mean observation time was 5.44 years. In total, there were 16,948 preterm deliveries (6.58%) and 14,448 births with at least one prior diagnosis of preeclampsia (5.61%). With a mean age of 30.51 years, 1,821 women developed any form of CKD. Compared to women with no risk exposure, women with a history of at least one preterm delivery (HR = 1.789) and women with a history of at least one preeclampsia (HR = 1.784) had an increased risk for any subsequent CKD. The highest risk for CKD was found for women with a joint exposure of preterm delivery and preeclampsia (HR = 5.227). These effects were the same in magnitude only for the outcome of mild to moderate CKD, but strongly increased for the outcome of severe CKD (HR = 11.90). Preterm delivery and preeclampsia were identified as independent risk factors for all CKD stages. A joint exposure or preterm birth and preeclampsia was associated with an excessive maternal risk burden for CKD in the first decade after pregnancy. Since consequent follow-up policies have not been defined yet, these results will help guide long-term surveillance for early detection and prevention of kidney disease, especially for women affected by both conditions.

Intelligence at Six Years in Relation to Neonatal Bilirubin Level: Follow-up of The National Institute of Child Health and Human Development Clinical Trial of Phototherapy

PEDIATRICS ◽  
1991 ◽  
Vol 87 (6) ◽  
pp. 797-805
Author(s):  
Peter C. Scheidt ◽  
Barry I. Graubard ◽  
Howard J. Hoffman ◽  
Dolores A. Bryla ◽  
Karin B. Nelson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Birth Weight ◽  
Child Health ◽  
Human Development ◽  
Bilirubin Level ◽  
Controlled Trial ◽  
Full Scale ◽  
The Central Nervous System ◽  
Bilirubin Toxicity

Results of the National Institute of Child Health and Human Development Randomized Controlled Trial of Phototherapy were examined for the relationship of neonatal bilirubin level to neurological and developmental outcome at 6-year follow-up. This analysis focused on 224 control children with birth weight of less than 2000 g. Bilirubin levels were maintained below previously specified levels by the use of exchange transfusion only (24%). Rates of cerebral palsy were not significantly higher for children with elevated maximum bilirubin level than for those whose level remained low. No association was evident between maximum bilirubin level and IQ (Full Scale, Verbal, or Performance) by simple correlation analysis (r = -.087, P = .2 for Full Scale) or by multiple linear regression adjusting for factors that covary with IQ (β = -.15, P = .58). IQ was not associated with mean bilirubin level, time and duration of exposure to bilirubin, or measures of bilirubin-albumin binding. Thus, over the range of bilirubin levels permitted in this clinical trial, there was no evidence of bilirubin toxicity to the central nervous system. Measures used to control the level of bilirubin in low birth weight neonates appear to prevent effectively the risk of bilirubin-induced neurotoxicity.

Sign in / Sign up

Export Citation Format

Share Document