Pregnancy Outcomes of Women Receiving Compounded 17 α-Hydroxyprogesterone Caproate for Prophylactic Prevention of Preterm Birth 2004 to 2011

Sibai, Bahaeddine M; Istwan, Niki; Palmer, Beverly; Stanziano, Gary

doi:10.1055/s-0032-1311979

Cited by 17 publications

(9 citation statements)

References 13 publications

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“…Based on the assumption that only 60% of eligible women used 17OHP-C (9), we would have at least 80% power to see the following differences: for exposure variables with a prevalence of 10%, we could detect a 2.25-fold difference in 17OHP-C use; 20% prevalence, a 1.25-fold difference; 40% prevalence, a 1.5-fold difference; and for 60% prevalence, a 1.5-fold difference.…”

Section: Methodsmentioning

confidence: 99%

“…Lastly, at the health systems level, women may not be seeking prenatal care at an early enough gestational age to initiate the medication, may have difficulty in obtaining it and arranging weekly administration, or their insurance may not fully cover the medication. (8–9) In a survey of general obstetrician-gynecologists exploring attitudes regarding the use of 17OHP-C, respondents reported that they prescribed 17OHP-C to only 59% of eligible patients. (10) While evidence regarding the efficacy of 17OHP-C in reducing the risk of recurrent spontaneous preterm birth continues to mount, it is of critical importance to understand what biases affect its use in clinical practice.…”

Section: Introductionmentioning

confidence: 99%

“…(10) While evidence regarding the efficacy of 17OHP-C in reducing the risk of recurrent spontaneous preterm birth continues to mount, it is of critical importance to understand what biases affect its use in clinical practice. (9, 11)…”

Section: Introductionmentioning

confidence: 99%

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

Turitz

Bastek

Purisch

et al. 2016

American Journal of Obstetrics and Gynecology

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BACKGROUND Preterm birth remains a significant cause of neonatal morbidity and mortality. Women with a prior preterm birth are at risk for recurrent preterm birth. Treatment with 17-alpha-hydroxyprogesterone caproate has become standard-of-care for women with prior preterm birth to help reduce this risk. Factors that affect a woman’s decision to use this medication are largely unknown. OBJECTIVE The objective of our study was to investigate patient level barriers to 17-alpha-hydroxyprogesterone caproate use. We studied a cohort of women eligible for 17-alpha-hydroxyprogesterone caproate with the hypothesis that 17-alpha-hydroxyprogesterone caproate is underutilized and certain patient characteristics, such as obstetrical history, influence its use. STUDY DESIGN A cross-sectional study of all women seen at a specialty prematurity clinic from 2009 to 2013 was performed. Women with a singleton pregnancy were included if they had a prior spontaneous preterm birth. Chi-squared tests were performed for univariate analyses. Multivariable logistic regression was used to control for confounders. RESULTS 243 women had 17-alpha-hydroxyprogesterone caproate recommended to them based on prior obstetrical history. There were 218 women with a pregnancy during our study period that were included in our analysis. 163 (74.7%) had documented 17-alpha-hydroxyprogesterone caproate use. Women were more likely to accept 17-alpha-hydroxyprogesterone caproate if they had a history of a second trimester loss only (OR 2.32, 1.17–4.58) or received recommendation for cerclage due to a short cervical length (OR 4.12, 1.55–10.99). Women with a prior full-term birth were less likely to accept 17-alpha-hydroxyprogesterone caproate (OR 0.48, 0.26–0.89), especially when the prior full-term birth was subsequent rather than prior to the preterm birth (OR 0.19, 0.08–0.47). Race, obesity, and insurance status did not impact 17-alpha-hydroxyprogesterone caproate use. There was no difference in the rate of spontaneous preterm birth between those who used and did not use 17-alpha-hydroxyprogesterone caproate (37.2 vs. 34.0%, p=0.7). CONCLUSION Past obstetric history impacted 17-alpha-hydroxyprogesterone caproate use. This study identifies biases regarding 17-alpha-hydroxyprogesterone caproate at the patient level and can be used to develop strategies to increase its use. However, the similarity in the spontaneous preterm birth rate between users and non-users highlights the importance of identifying specific populations where 17-alpha-hydroxyprogesterone caproate is and is not effective in preventing preterm birth.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Turitz

Bastek

Purisch

et al. 2016

American Journal of Obstetrics and Gynecology

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“…Arrangements were made for home delivery of unit dose, preservative-free vials of 17OHPC using the specifications and formulation of the 17OHPC used in the Meis et al Network Study including the vehicle (castor oil) [11]. Similar efficacy has been demonstrated between this compounded product and the product approved by the U.S. Food and Drug Administration, Makena (Ther-Rx Corporation, St. Louis, MO) [12]. A nurse and pharmacist were available continually for patient questions and concerns.…”

Section: Methodsmentioning

confidence: 99%

Maternal Characteristics Influencing the Development of Gestational Diabetes in Obese Women Receiving 17-alpha-Hydroxyprogesterone Caproate

et al. 2014

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Objective. Gestational diabetes (GDM) and obesity portend a high risk for subsequent type 2 diabetes. We examined maternal factors influencing the development of gestational diabetes (GDM) in obese women receiving 17-alpha-hydroxyprogesterone caproate (17OHPC) for preterm delivery prevention. Materials and Methods. Retrospectively identified were 899 singleton pregnancies with maternal prepregnancy body mass indices of ≥30 kg/m2 enrolled for either 17OHPC weekly administration (study group) or daily uterine monitoring and nursing assessment (control group). Patients with history of diabetes type 1, 2, or GDM were excluded. Maternal characteristics were compared between groups and for women with and without development of GDM. A logistic regression model was performed on incidence of GDM, controlling for significant univariate factors. Results. The overall incidence of GDM in the 899 obese women studied was 11.9%. The incidence of GDM in the study group (n = 491) was 13.8% versus 9.6% in the control group (n = 408) (P = 0.048). Aside from earlier initiation of 17OHP and advanced maternal age, other factors including African American race, differing degrees of obesity, and use of tocolysis were not significant risks for the development of GDM. Conclusion. In obese women with age greater than 35 years, earlier initiation of 17OHPC may increase the risk for GDM.

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“…One factor that the agency considers in determining whether a drug may be compounded is whether the prescribing practitioner has determined that a compounded product is necessary for the particular patient and would provide a significant difference for the patient as compared to the FDAapproved commercially available drug product" [33]. In addition, the safety and effectiveness of compounded 17-OHPC was confirmed in the pregnancy outcomes study of women receiving for prophylactic prevention of preterm birth [34]. Quality control of the active pharmaceutical ingredients and compounded products of 17 alpha hydroxyprogesterone caproate Further, our stability-indicating study [35] ( Table 4) also demonstrated that 17-OHPC appeared to be fairly stable when exposed for a short term to high temperature, light, strong acid, different preservatives, and different dispensing containers under respective experimental conditions.…”

Section: Fda-approved Product and Compounded Versionmentioning

confidence: 99%

Pharmacy Compounding Quality Control and Pharmaceutical Development Strategies for Seventeen alpha Hydroxyprogesterone Caproate in Prevention of Preterm Delivery

Zhao¹,

Caritis²,

Venkataramanan³

2014

Journal of Pharmaceutics and Drug Development

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Pregnancy Outcomes of Women Receiving Compounded 17 α-Hydroxyprogesterone Caproate for Prophylactic Prevention of Preterm Birth 2004 to 2011

Abstract: Home nurse administration of compounded 17P is safe and effective.

Cited by 17 publications

References 13 publications

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

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

Maternal Characteristics Influencing the Development of Gestational Diabetes in Obese Women Receiving 17-alpha-Hydroxyprogesterone Caproate

Pharmacy Compounding Quality Control and Pharmaceutical Development Strategies for Seventeen alpha Hydroxyprogesterone Caproate in Prevention of Preterm Delivery

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