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.

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 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

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.

scholarly journals Candida Chorioamnionitis in Mothers with Gestational Diabetes Mellitus: A Report of Two Cases

2021 ◽  
Vol 18 (14) ◽  
pp. 7450
Author(s):  
Elia Shazniza Shaaya ◽  
Siti Atiqah Abdul Halim ◽  
Ka Wen Leong ◽  
Kevin Boon Ping Ku ◽  
Pei Shan Lim ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Umbilical Cord ◽  
Neonatal Death ◽  
Periodic Acid ◽  
Careful Examination ◽  
Periodic Acid Schiff ◽  
History Of ◽  
Methenamine Silver

Background:Candida chorioamnionitis is rarely encountered, even though vulvovaginal candidiasis incidence is about 15%. Interestingly, it has characteristic gross and histological findings on the umbilical cord that are not to be missed. Case Report: We report two cases of Candida chorioamnionitis with presence of multiple yellowish and red spots of the surface of the umbilical cord. Microscopically, these consist of microabscesses with evidence of fungal yeasts and pseudohyphae. The yeasts and pseudohyphae were highlighted by periodic acid– Schiff and Grocott methenamine silver histochemical stains. Both cases were associated with a history of gestational diabetes mellitus. Discussion: Peripheral funisitis is a characteristic feature of Candida chorioamnionitis. It is associated with high risk of adverse perinatal and neonatal outcomes, such as preterm delivery, stillbirth and neonatal death. We recommend careful examination of the umbilical cord of mothers with gestational diabetes mellitus.

Eligibility, Utilization, and Effectiveness of 17-Alpha Hydroxyprogesterone Caproate (17OHPC) in a Statewide Population-Based Cohort of Medicaid Enrollees

2021 ◽  
Author(s):  
Xi Wang ◽  
Stephanie M. Garcia ◽  
Katherine S. Kellom ◽  
Rupsa C. Boelig ◽  
Meredith Matone
Keyword(s):  
Preterm Birth ◽  
Neonatal Intensive Care ◽  
Population Based ◽  
Primary Objective ◽  
Birth Certificates ◽  
Spontaneous Preterm Birth ◽  
Initiation Rate ◽  
Live Births ◽  
Hydroxyprogesterone Caproate ◽  
Comparison Groups

Objectives The primary objective was to estimate the initiation and adherence rates of 17 α-hydroxyprogesterone caproate (17OHPC) among eligible mothers in a statewide population-based cohort of Medicaid enrollees. The secondary objectives were to (1) determine the association of maternal sociodemographic and clinical characteristics with 17OHPC utilization and (2) assess the real-world effectiveness of 17OHPC on recurrent preterm birth prevention and admission to neonatal intensive care unit (NICU). Study Design This is a retrospective cohort study using a linked, longitudinal administrative dataset of birth certificates and medical assistance claims. Medicaid-enrolled mothers in Pennsylvania were included in this study if they had at least one singleton live birth from 2014 to 2016 following at least one spontaneous preterm birth. Maternal Medicaid claims were used to ascertain the use of 17OHPC from various manufacturers, including compounded formulations. Propensity score matching was used to create a covariate balance between 17OHPC treatment and comparison groups. Results We identified 4,781 Medicaid-covered 17OHPC-eligible pregnancies from 2014 to 2016 in Pennsylvania, 3.4% of all Medicaid-covered singleton live births. The population-based initiation rate was 28.5% among eligible pregnancies. Among initiators, 50% received ≥16 doses as recommended, while 10% received a single dose only. The severity of previous spontaneous preterm birth was the strongest predictor for the initiation and adherence of 17OHPC. In the matched treatment (n = 1,210) and comparison groups (n = 1,210), we found no evidence of 17OHPC effectiveness. The risks of recurrent preterm birth (relative risk [RR] 1.10, 95% confidence interval [CI] 0.97–1.24) and births admitted to NICU (RR 1.00, 95% CI 0.84–1.18) were similar in treated and comparison mothers. Conclusion The 17OHPC-eligible population represented 3.4% of singleton live births. Less than one-third of eligible mothers initiated treatment. Among initiators, 50% were treatment adherent. We found no difference in the risk of recurrent preterm birth or admission to NICU between treatment and comparison groups. Key Points

Effectiveness of 17-OHP for Prevention of Recurrent Preterm Birth: A Retrospective Cohort Study

2021 ◽  
Author(s):  
Blair J. Wylie ◽  
Andrew L. Beam ◽  
Joe B. Hakim ◽  
Amy Zhou ◽  
Sonia Hernandez-Diaz ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Propensity Score ◽  
Evidence Base ◽  
Inclusion Criteria ◽  
Spontaneous Preterm Birth ◽  
Real World Data ◽  
Recurrence Rates ◽  
Key Points ◽  
Hydroxyprogesterone Caproate ◽  
Risk Ratios

Objective 17-α-hydroxyprogesterone caproate (17-OHP) has been recommended by professional societies for the prevention of recurrent preterm birth, but subsequent clinical studies have reported conflicting efficacy results. This study aimed to contribute to the evidence base regarding the effectiveness of 17-OHP in clinical practice using real-world data. Study Design A total of 4,422 individuals meeting inclusion criteria representing recurrent spontaneous preterm birth (sPTB) were identified in a database of insurance claims, and 568 (12.8%) received 17-OHP. Crude and propensity score-matched recurrence rates and risk ratios (RRs) for the association of receiving 17-OHP on recurrent sPTB were calculated. Results Raw sPTB recurrence rates were higher among those treated versus not treated; after propensity score matching, no association was detected (26.3 vs. 23.8%, RR = 1.1, 95% CI: 0.9–1.4). Conclusion We failed to identify a beneficial effect of 17-OHP for the prevention of spontaneous recurrent preterm birth in our observational, U.S. based cohort. Key Points

Cervical Length Surveillance After 24 Weeks in Women With a History of Spontaneous Preterm Birth [09K]

2020 ◽  
Vol 135 ◽  
pp. 116s
Author(s):  
Eboni Jones ◽  
Kari Whitley ◽  
Joanne Quinones ◽  
Danielle Durie ◽  
Katherine Fradeneck
Keyword(s):  
Preterm Birth ◽  
Cervical Length ◽  
Spontaneous Preterm Birth ◽  
History Of
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