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

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. 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. 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. 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.

DeNoble AE ，Wynn CE ，Weaver KE ，Wheeler SM ，Swamy GK ... -  《-》

Racial and ethnic disparities in use of 17-alpha hydroxyprogesterone caproate for prevention of preterm birth.

Racial/ethnic disparities in preterm birth remain a major public health challenge in the United States. While 17-alpha hydroxyprogesterone caproate (17OHP-C) is recommended for preterm birth prevention in women with a prior preterm birth, non-Hispanic black women continue to experience higher rates of recurrent preterm birth than white women receiving the same treatment. Further investigation of disparities in 17OHP-C use and adherence is warranted. We sought to evaluate whether racial and ethnic disparities exist in the use of and adherence to 17OHP-C within a population of eligible women. This was a retrospective cohort study of women with a prior spontaneous, singleton preterm birth who were eligible for 17OHP-C for preterm birth prevention and received care at a single institution from 2010 through 2014. Associations between self-identified race/ethnicity (non-Hispanic black vs women in all other racial/ethnic groups) and documented counseling about 17OHP-C, receipt of any 17OHP-C, and adherence to 17OHP-C administration were each estimated by bivariable analysis and multivariable logistic regression. Adherence to 17OHP-C was defined as not >1 missed dose, initiation <20 weeks' gestational age, and continuation until 37 weeks or delivery. Of 472 women who were clinically eligible for 17OHP-C, 72% (N = 296) had documented 17OHP-C counseling and 48.9% (N = 229) received 17OHP-C. There were no differences in likelihood of 17OHP-C counseling or receipt of 17OHP-C based on race/ethnicity. While overall 83% (N = 176) of women were adherent to 17OHP-C, only 70% (N = 58) of non-Hispanic black women were adherent, compared to 91% (N = 118) of all other women (P < .001). Non-Hispanic black women had more missed doses (2.4 vs 0.4 doses, P < .001) and later initiation of care (12.0 vs 10.2 weeks, P < .001) than women in other racial/ethnic groups. After adjustment for potential confounders, non-Hispanic black women were significantly less likely to be adherent to 17OHP-C (adjusted odds ratio, 0.16; 95% confidence interval, 0.04-0.65). A significant interaction between non-Hispanic black race/ethnicity and public insurance was identified (adjusted odds ratio, 0.16; 95% confidence interval, 0.05-0.52). In a diverse cohort of women eligible for preterm birth prevention, non-Hispanic black women are at an increased risk of nonadherence to 17OHP-C. Non-Hispanic black women with public insurance are at a particularly increased risk of nonadherence.

Yee LM ，Liu LY ，Sakowicz A ，Bolden JR ，Miller ES ... -  《-》

Disparities in 17-Hydroxyprogesterone Caproate Offer and Uptake in Pregnancies at a Risk of Preterm Birth.

To evaluate the offer, acceptance, uptake, and patient experience with 17-hydroxyprogesterone caproate (17OHP-C) over the course of 10 years. This is a retrospective cohort study with a qualitative component. We identified all women with spontaneous preterm deliveries with subsequent births in our hospital between 2005 and 2015. We used linear regression to calculate unadjusted odds ratios for 17OHP-C offer, acceptance, and doses received associated with predictors of interest, and multivariable modeling further adjusted for potential confounders. A grounded theory approach was used to glean recurrent themes surrounding the patient experience. A total of 265 women fit the eligibility criteria; 39.6% were offered 17OHP-C and 83.8% accepted 17OHP-C. The mean number of documented 17OHP-C doses was 15.7 ± 5.4. Women were less likely to be offered 17OHP-C if they had public insurance or if their earliest preterm birth was of greater gestational age. Non-Hispanic black women were documented to have received four fewer doses than white women. We also identified recurrent themes that hindered acceptance and adherence to 17OHP-C: insurance difficulties, unstable housing, lack of childcare, and job inflexibility. Women at a risk of preterm birth are more likely to be offered and receive 17OHP-C if they have private insurance and have had an earlier preterm birth. Non-Hispanic black women were documented to have received fewer doses of 17OHP-C than white women. Further inquiry into the structural causes that lead to disparities in care for women at a risk for preterm birth is important.

Berhie SH ，Riley LE ，Bryant AS 《-》

Patient characteristics associated with 17-alpha hydroxyprogesterone caproate use among a high-risk cohort.

Preterm birth (PTB) remains a significant cause of neonatal morbidity and mortality. Women with a prior PTB are at risk for recurrent PTB. Treatment with 17-alpha hydroxyprogesterone caproate (17OHP-C) has become standard of care for women with prior PTB to help reduce this risk. Factors that affect a woman's decision to use this medication are largely unknown. The objective of our study was to investigate patient-level barriers to 17OHP-C. We studied a cohort of women eligible for 17OHP-C with the hypothesis that 17OHP-C is underutilized and certain patient characteristics, such as obstetrical history, influence its use. A cross-sectional study of all women seen at a specialty prematurity clinic from 2009 through 2013 was performed. Women with a singleton pregnancy were included if they had a prior spontaneous PTB (sPTB). The χ(2) tests were performed for univariate analyses. Multivariable logistic regression was used to control for confounders. In all, 243 women had 17OHP-C recommended to them based on obstetrical history. There were 218 women with a pregnancy during our study period that were included in our analysis. A total of 163 (74.7%) had documented 17OHP-C use. Women were more likely to accept 17OHP-C if they had a history of a second-trimester loss only (odds ratio [OR], 2.32; 95% confidence interval [CI], 1.17-4.58) or received recommendation for cerclage due to a short cervical length (OR, 4.12; 95% CI, 1.55-10.99). Women with a prior full-term birth were less likely to accept 17OHP-C (OR, 0.48; 95% CI, 0.26-0.89), especially when the prior full-term birth was subsequent rather than prior to the PTB (OR, 0.19; 95% CI, 0.08-0.47). Race, obesity, and insurance status did not impact 17OHP-C use. There was no difference in the rate of sPTB between those who used and did not use 17OHP-C (37.2 vs 34.0%, P = .7). Obstetric history impacted 17OHP-C use. This study identifies biases regarding 17OHP-C at the patient level and can be used to develop strategies to increase its use. However, the similarity in the sPTB rate between users and nonusers highlights the importance of identifying specific populations where 17OHP-C is and is not effective in preventing PTB.

Turitz AL ，Bastek JA ，Purisch SE ，Elovitz MA ，Levine LD ... -  《-》

Gestational age at initiation of 17-alpha hydroxyprogesterone caproate and recurrent preterm birth.

Preterm birth is the leading cause of neonatal morbidity and mortality in nonanomalous neonates in the United States. Women with a previous early spontaneous preterm birth are at highest risk for recurrence. Weekly intramuscular 17-alpha hydroxyprogesterone caproate reduces the risk of recurrent prematurity. Although current guidelines recommend 17-alpha hydroxyprogesterone caproate initiation between 16 and 20 weeks, in clinical practice, 17-alpha hydroxyprogesterone caproate is started across a spectrum of gestational ages. The objective of the study was to examine the relationship between the gestational age at 17-alpha hydroxyprogesterone caproate initiation and recurrent preterm birth among women with a prior spontaneous preterm birth 16-28 weeks' gestation. This was a retrospective cohort study of women from a single tertiary care center, 2005-2016. All women with ≥1 singleton preterm births because of a spontaneous onset of contractions, preterm prelabor rupture of membranes, or painless cervical dilation between 16 and 28 weeks followed by a subsequent singleton pregnancy treated with 17-alpha hydroxyprogesterone caproate were included. Women were grouped based on quartiles of gestational age of 17-alpha hydroxyprogesterone caproate initiation (quartile 1, 140/7 to 161/7; quartile 2, 162/7 to 170/7; quartile 3, 171/7 to 186/7; and quartile 4, 190/7 to 275/7). Women with a gestational age of 17-alpha hydroxyprogesterone caproate initiation in quartiles 1 and 2 were considered to have early-start 17-alpha hydroxyprogesterone caproate; those in quartiles 3 and 4 were considered to have late-start 17-alpha hydroxyprogesterone caproate. The primary outcome was recurrent preterm birth <37 weeks' gestation. Secondary outcomes included recurrent preterm birth <34 and <28 weeks' gestation and composite major neonatal morbidity (diagnosis of grade III or IV intraventricular hemorrhage, periventricular leukomalacia, bronchopulmonary dysplasia, necrotizing enterocolitis stage II or III, or death). Gestational age at delivery was compared by quartile of 17-alpha hydroxyprogesterone caproate initiation using Kaplan-Meier survival curves and the log-rank test. Logistic regression models estimated odds ratios for the association between gestational age at 17-alpha hydroxyprogesterone caproate initiation and preterm birth <37 weeks' gestation, adjusting for demographics, prior pregnancy and antenatal characteristics. A total of 132 women met inclusion criteria; 52 (39.6%) experienced recurrent preterm birth <37 weeks in the studied pregnancy. 17-Alpha hydroxyprogesterone caproate was initiated at a mean 176/7 ± 2.5 weeks. Demographic and baseline characteristics were similar between women with early-start 17-alpha hydroxyprogesterone caproate (quartiles 1 and 2) compared with those with late-start 17-alpha hydroxyprogesterone caproate (quartiles 3 and 4). Women with early-start 17-alpha hydroxyprogesterone caproate trended toward lower rates of recurrent preterm birth <37 weeks compared with those with late-start 17-alpha hydroxyprogesterone caproate (41.3% vs 57.7%, P = .065). Delivery gestational age was inversely proportional to gestational age at 17-alpha hydroxyprogesterone caproate initiation (quartile 1, 374/7 weeks vs quartile 2, 365/7 vs quartile 3, 361/7 weeks vs quartile 4, 340/7, P = .007). In Kaplan-Meier survival analyses, these differences in delivery gestational age by 17-alpha hydroxyprogesterone caproate initiation quartile persisted across pregnancy (log-rank P < .001). In regression models, later initiation of 17-alpha hydroxyprogesterone caproate was significantly associated with increased odds of preterm birth <37 weeks. Women with early 17-alpha hydroxyprogesterone caproate initiation also had lower rates of major neonatal morbidity than those with later 17-alpha hydroxyprogesterone caproate initiation (1.5% vs 14.3%, P = .005). Rates of recurrent preterm birth among women with a prior spontaneous preterm birth 16-28 weeks are high. Women beginning 17-alpha hydroxyprogesterone caproate early deliver later and have improved neonatal outcomes. Clinicians should make every effort to facilitate 17-alpha hydroxyprogesterone caproate initiation at 16 weeks.

Ning A ，Vladutiu CJ ，Dotters-Katz SK ，Goodnight WH ，Manuck TA ... -  《-》