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The inability to support the growth and development of a mature fetus up to delivery results in significant human suffering. Current available solutions include adoption, surrogacy, and uterus transplantation. However, these options are subject to several ethical, religious, economic, social, and medical concerns. Ectogenesis is the process in which an embryo develops in an artificial uterus from implantation through to the delivery of a live infant. This current narrative review summarizes the state of recent research focused on human ectogenesis. First, a literature search was performed to identify published reports of previous experiments and devices used for embryo implantation in an extracorporeally perfused human uterus. Furthermore, studies fitting that aim were selected and critically evaluated. Results were synthesized, interpreted, and used to design a prospective strategy for future research. Therefore, this study suggests that full ectogenesis might be obtained using a computer-controlled system with extracorporeal blood perfusion provided by a digitally controlled heart-lung-kidney system. From a clinical perspective, patients who will derive significant benefits from this technology are mainly those women diagnosed with anatomical abnormalities of the uterus and those who have undergone previous hysterectomies, numerous abortions, and experienced premature birth. Ectogenesis is the complete development of an embryo in an artificial uterus. It represents the solutions for millions of women suffering from premature deliveries, and the inability to supply growth and development of embryos/fetuses in the womb. In the future, ectogenesis might replace uterine transplantation and surrogacy.

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Vaginal progesterone (VP) has been recommended to prevent preterm birth (PTB) in women at high-risk. However, there is controversy as to whether VP is efficacious in some subsets of high-risk women. In this review, we examined the current best evidence on the efficacy of VP to prevent PTB in several subsets of high-risk women and provided recommendations for its clinical use. Compelling evidence indicates that VP reduces the risk of PTB and improves perinatal outcomes in singleton gestations with a short cervix (≤25 mm), both with and without a history of spontaneous PTB. VP appears promising to reduce the risk of PTB in twin gestations with a short cervix (≤25 mm) and in singleton gestations conceived by assisted reproductive technologies, but further research is needed. There is no convincing evidence that supports prescribing VP to prevent PTB in singleton gestations based solely on the history of spontaneous preterm birth. Persuasive evidence shows that VP does not prevent PTB nor does it improve perinatal outcomes in unselected twin gestations and in singleton gestations with a history of spontaneous PTB and a cervical length >25 mm. There is no evidence supporting the use of VP to prevent PTB in triplet or higher-order multifetal gestations, singleton gestations with a positive fetal fibronectin test and clinical risk factors for PTB, and gestations with congenital uterine anomalies or uterine leiomyoma. In conclusion, current evidence indicates that VP should only be recommended in singleton gestations with a short cervix, regardless of the history of spontaneous PTB.

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OBJECTIVES: The US preterm birth rate varies dramatically by race and ethnicity yet the racial and ethnic representation within studies evaluating 17-hydroxprogesterone caproate (17-P) for preterm birth prevention is unknown. The objectives of our study were to 1) examine the racial and ethnic representation of participants in 17-P preterm birth prevention studies, 2) evaluate adherence to the NIH race and ethnicity reporting guidelines and 3) compare racial and ethnic representation in research studies to national preterm birth incidence. METHODS: We systematically reviewed US studies published between January 2000 and December 2019. Study participant's race and ethnicity were reported using descriptive statistics then compared to US 2017//2018 preterm birth data using Pearson's chi-square. RESULTS: Eighteen studies met the inclusion criteria, 17 studies reported race, 11 studies reported ethnicity, and yet none of the studies followed the NIH criteria. Compared to 2017/2018 US preterm births, the proportion of black/African American study participants was significantly higher whereas the proportions of all other race categories were lower. CONCLUSIONS: More detailed reporting of race and ethnicity is needed in 17-P literature. Black women appear to be well represented while other racial and ethnic groups may be understudied.

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BACKGROUND: Preterm birth (PTB) is a syndrome resulting from a complex list of underlying causes and factors, and whether these risk factors differ in the context of prior PTB history is less understood. The aim of this study was to explore whether PTB risk factors in a second pregnancy were different in women with versus without previous PTB. METHODS: We conducted a population-based cohort study using data from the birth cohort of the Center for Data and Knowledge Integration for Health (CIDACS) for the period 2001 to 2015. We used longitudinal transition models with multivariate logistic regression to investigate whether risk factors varied between incident and recurrent PTB. RESULTS: A total of 3,528,050 live births from 1,764,025 multiparous women were analyzed. We identified different risk factors (Pdifference <0.05) between incident and recurrent PTB. The following were associated with an increased chance for PTB incidence, but not recurrent: household overcrowding (OR 1.09), maternal race/ethnicity [(Black/mixed-OR 1.04) and (indigenous-OR 1.34)], young maternal age (14 to 19 years-OR 1.16), and cesarean delivery (OR 1.09). The following were associated with both incident and recurrent PTB, respectively: single marital status (OR 0.85 vs 0.90), reduced number of prenatal visits [(no visit-OR 2.56 vs OR 2.16) and (1 to 3 visits-OR 2.44 vs OR 2.24)], short interbirth interval [(12 to 23 months-OR 1.04 vs OR 1.22) and (<12 months, OR 1.89, 95 vs OR 2.58)], and advanced maternal age (35-49 years-OR 1.42 vs OR 1.45). For most risk factors, the point estimates were higher for incident PTB than recurrent PTB. CONCLUSIONS: The risk factors for PTB in the second pregnancy differed according to women's first pregnancy PTB status. The findings give the basis for the development of specific prevention strategies for PTB in a subsequent pregnancy.

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OBJECTIVES: Emergency caesarean sections (EmCS), particularly those performed in the second stage of labour, have been associated with a risk of subsequent preterm birth. More worrying is that the risk of sPTB recurrence appears to be high in women who have had a second stage EmCS and a subsequent sPTB. However, there is a paucity of evidence regarding the risk of recurrence in women who have had a prior term EmCS at any stage of labour followed by a sPTB. This study aims to investigate the relationship between all term in labour EmCS and the risk of recurrent spontaneous preterm birth (sPTB). STUDY DESIGN: This is an observational, retrospective cohort study conducted at St Thomas' Hospital, a tertiary-level maternity hospital in London, United Kingdom. 259 women were included; 59 women with a term in labour EmCS preceding a sPTB (EmCS group) and 200 women with a prior sPTB only (control group). The initial EmCS was further categorised into first stage (FS)-EmCS or second stage (SS)-EmCS. Primary outcome was sPTB in Pregnancy C < 37 weeks' gestation. Secondary outcomes included sPTB < 34 weeks' and < 24 weeks' gestation. RESULTS: 54% (32/59) of the EmCS group had a recurrent sPTB < 37 weeks compared to 20% (40/200) of the control women (p < 0.0001) with a relative risk of 2.71 [95%CI 1.87-3.87]). Of women who had a SS-EmCS and a subsequent PTB, 61.9% (13/21) had a further sPTB (RR 3.0 [95%CI, 1.8-4.5] compared to control women). In addition, there is nearly a 6-fold increased risk of a recurrent sPTB or midtrimester loss < 24 weeks' gestation in these women (RR 5.65 [95%CI2.6-12.0]). CONCLUSIONS: In women who have had a previous sPTB in which a term in labour EmCS is a risk factor, the risk of a further sPTB is much higher than in those women where a prior sPTB is the sole risk factor. Furthermore, EmCS at both the first and second stage of labour are associated with a increased risk of recurrent sPTB. Further work should ascertain which women who have had a prior term EmCS are at risk of sPTB and recurrence, and how best to identify and treat them.

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OBJECTIVE: This study aimed to clarify the effectiveness of cervical cerclage in preventing recurrent preterm births. MATERIALS AND METHODS: A retrospective study was conducted using the perinatal registration database of the Japan Society of Obstetrics and Gynecology for the Perinatal Center from 2014 to 2016. The efficacies of history-indicated, ultrasound-indicated, and physical examination-indicated cerclage as preventive treatments for women with a history of preterm birth were evaluated by comparing cerclage and non-cerclage cases. Fisher's exact test was performed to evaluate any significant differences in patient backgrounds. Prior to the evaluation, propensity score matching was performed for history-indicated and ultrasound-indicated cerclage patients. RESULTS: For this study, 6060 multiparous women with a history of preterm birth were reviewed. After excluding 17 patients with unknown indications for cervical cerclage, 6043 patients were included in the study. History-indicated and ultrasound-indicated cerclage did not reduce the risk of preterm birth in subsequent pregnancies for any of the pregnancy periods (p = 0.413, p = 1.000). In contrast, physical examination-indicated cerclage significantly reduced the risk of subsequent preterm births for all pregnancy periods (p < 0.001). CONCLUSION: Subsequent preterm births were effectively prevented only in physical examination-indicated cerclage cases. For history- or ultrasound-indicated cerclage, statistically significant differences in subsequent preterm births were not evident.

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Major fetal anomalies (MFA) are a known risk factor for preterm birth (PTB), though the etiology of this is not well-studied, making counseling of these patients difficult. Thus, we sought to describe the rate of recurrent PTB in a second-observed pregnancy among persons with a history of PTB of an infant with a MFA in a first observed pregnancy, and to assess the difference in delivery timing between the first- and second-observed pregnancy. This was a retrospective cohort study of patients with a first-observed pregnancy complicated by MFA and a second-observed pregnancy in single healthcare system between 2013 and 2017. The primary outcome was recurrent PTB (PTB in second-observed pregnancy) and secondary outcomes were recurrent spontaneous PTB (SPTB), delivery gestational age (GA) in second-observed pregnancy, and difference in delivery GA between the first- and second-observed pregnancy. Recurrent PTB in the setting of prior PTB complicated by an MFA is common (∼1/4 patients), though median delivery timing for individuals who delivered preterm in the first-observed pregnancy was 6 weeks later in the second-observed pregnancy. These data suggest that PTB in the setting of MFA is a comparable risk factor to PTB in the absence of MFA.

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OBJECTIVE: To investigate the recurrence of preterm birth (PTB) among the poorest half of the Brazilian population. METHODS: A population-based retrospective study was conducted in Brazil with the live births of multiparous women extracted from the CIDACS Birth Cohort between 2001 and 2015. We used multivariate logistic regression to estimate the odds of recurrent PTB in second and third births. RESULTS: A total of 3 528 050 live births from 1 764 025 multiparous women were analyzed. The adjusted odds for the occurrence of a PTB given a previous PTB was 2.58 (95% confidence interval [CI] 2.53-2.62). Lower gestational age increased the odds of a subsequent PTB (<28 weeks: adjusted OR [aOR] 3.61, 95% CI 3.41-3.83; 28-31 weeks: aOR 3.34, 95% CI 3.19-3.49; and 32-36 weeks: aOR 2.42, 95% CI 2.38-2.47). Women who had two previous PTBs were at high risk of having a third (aOR 4.98, 95% CI 4.70-5.27). Recurrence of PTB was more likely when the inter-birth interval was less than 12 months. CONCLUSION: In Brazil, a middle-income country, women with a previous PTB had an increased risk of a subsequent one. This association was affected by gestational age, the number of PTBs, severity of previous PTBs, and a short interval between births.

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Background: Preterm birth (PTB) is a leading cause of neonatal morbidity and mortality. Objective: To estimate the effect of 17-alpha-hydroxyprogesterone caproate (17-OHPC) compared to placebo in singleton gestations for reducing the risk of recurrent PTB and neonatal morbidity and mortality. Work Design: Systematic review and meta-analysis. Search Strategy: Searching MEDLINE, Embase, Web of Science, SCOPUS, Cochrane Library, and clinical trial registries. Selection Criteria: Randomized controlled trials of singleton gestations with a history of PTB and treated with a weekly intramuscular injection of 17-OHPC or placebo. Data Collection and Analysis: A random meta-analysis model was performed for the PTB outcomes (<32, <35, and <37 weeks) and neonatal outcomes (neonatal death, grade 3 or 4 intraventricular hemorrhage, respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, and sepsis). Effect estimates were measured by relative risk ratio (RR) with a 95% confidence interval (CI). Main Results: Six works were included. There were no statistically significant reductions in the PTB risk following the use of 17-OHPC at <32 weeks (RR = 0.61, 95% CI: 0.13-2.77, and I 2 = 39%), <35weeks (RR = 0.60, 95% CI: 0.10-3.67, and I 2 = 51%), and <37 weeks (RR = 0.68, 95% CI: 0.46-1, and I 2 = 75%). Furthermore, all the neonatal outcomes were statistically similar between the two groups. Conclusion: Treatment with 17-OHPC is not associated with reducing the risk of PTB or neonatal outcomes compared to placebo.

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Background: Preterm birth (PTB) is a pressing maternal and child health issue with long-standing racial inequities in outcomes and care provision. 17-Alpha-hydroxyprogesterone caproate (17OHPC) has been one of few clinical interventions for recurrent PTB prevention. Little is known about the factors influencing successful administration and receipt of 17OHPC among mothers in the Medicaid program. Materials and Methods: We conducted individual semistructured interviews with 17OHPC-eligible pregnant women and obstetric providers from two academic medical centers in Philadelphia, PA. Patient participants were publicly insured, eligible for 17OHPC treatment, and purposively sampled as either (1) actively receiving treatment or (2) declining/discontinuing treatment. Providers had experience providing care to Medicaid-enrolled patients. Interview transcripts were coded and analyzed to identify themes related to treatment acceptability, access, and adherence. Results: Of the 17 patient participants, the mean age was 30 years. Ten providers (MDs, nurse practitioners, and registered nurses) were also interviewed. Factors facilitating 17OHPC uptake and adherence among patients included severity of prior PTB, provider counseling, and coordination among the clinic, pharmacy, and insurance. Pain was cited as the most significant barrier to 17OHPC for patients, while providers perceived social adversity and beliefs about patients' commitment to treatment to be primary patient barriers. For providers, clinical experience and practice guidelines contributed to their use of 17OHPC. Administrative complexity and coordination of services were the primary provider barrier to 17OHPC administration. Conclusions: Patient-provider communication is a primary driver of 17OHPC acceptability and adherence. Comprehensive patient-centered consultation may improve uptake of clinical therapies among pregnant women at high risk for PTB.

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BACKGROUND: Progesterone has been used for preventing preterm birth with mixed results. The American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine recommended the use of 17-hydroxyprogesterone caproate for risk reduction of recurrent spontaneous preterm birth based on the results of a multicenter, randomized trial in the United States. However, recent literature lacks consensus for efficacy in the American population. In addition, partial adherence and outcomes thereof are underreported. Hence, the relationship between practical adherence to 17-hydroxyprogesterone caproate and outcomes were evaluated. OBJECTIVE: The objective of this study was to evaluate the adherence to 17-hydroxyprogesterone caproate, defined as receipt of greater than 80% of intended injections, at an outpatient maternal-fetal medicine center and its effect on maternal and neonatal outcomes. STUDY DESIGN: This retrospective cohort study included women older than 18 years with a singleton gestation, history of spontaneous preterm birth who initiated 17-hydroxyprogesterone caproate weekly injections between 16 and 20 weeks' gestational age and delivered between the years 2014 and 2017. Women receiving 17-hydroxyprogesterone caproate injections outside of the clinic were excluded. The primary outcome of adherence and secondary outcomes of gestational age at delivery, birthweight, and neonatal outcomes were analyzed using descriptive data, independent t-test, Mann-Whitney U test, chi-square test, and Fisher exact test, where appropriate, with a P value <.05 being considered significant. RESULTS: Adherence to 17-hydroxyprogesterone caproate occurred in 38 of 92 (41.3%) women included in the study. At baseline, there was a difference in age between groups of adherent and nonadherent women (adherent: 30.8 years; nonadherent: 27.4 years; P=.002). The rate of spontaneous preterm birth less than 37, 35, and 32 weeks were not significantly different in those who were adherent vs nonadherent to 17-hydroxyprogesterone caproate. There were no differences in gestational age at delivery (adherent: 36.8±2.6 weeks; nonadherent: 36.5±3.8 weeks; P=.66), birthweight (adherent: 2776 g; nonadherent: 2709 g; P=.68), or composite neonatal morbidity (adherent: 18.4%; nonadherent: 20.4%; P=.86) between the adherent and nonadherent groups. Neonatal intensive care unit length of stay was 15.5 days in the adherent group compared with 15 days in the nonadherent group (P=.72). CONCLUSION: Real-world adherence to 17-hydroxyprogesterone caproate is suboptimal with less than half of women adherent to in-clinic administration. Adherence to 17-hydroxyprogesterone caproate was not associated with a difference in gestational age at delivery or birthweight compared with nonadherence. Further studies are needed to assess the outpatient administration and benefit of 17-hydroxyprogesterone caproate therapy.

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BACKGROUND: Preterm birth causes an increased risk for perinatal morbidity and mortality. OBJECTIVE: To determine whether mid-trimester 17-alpha-hydroxyprogesterone caproate (17-OHPC) reduces the risk of recurrent preterm birth and adverse perinatal outcomes. SEARCH STRATEGY: Systematic search to identify relevant studies published in different languages, registered after 2000, using appropriate MeSH terms. SELECTION CRITERIA: Inclusion criteria were women between 16 and 26+6  weeks of pregnancy with history of preterm delivery in any pregnancy randomized to either 17-OHPC or placebo/no treatment. DATA COLLECTION AND ANALYSIS: The number of preterm births and adverse outcomes in the 17-OHPC and placebo arms over the total number of patients in each randomized group were used to calculate the risk ratio (RR) by random-effects models using the Mantel-Haenszel method. Between-study heterogeneity was assessed using tau2 , χ2 (Cochrane Q), and I2 statistics. MAIN RESULTS: Four studies were included. There was a 29% (RR 0.71; 95% CI, 0.53-0.96; P=0.001), 26% (RR 0.74; 95% CI, 0.58-0.96; P=0.021), and 40% (RR 0.60; 95% CI, 0.42-0.85; P=0.004) reduction in recurrent preterm birth at <37, <35, and <32 weeks, respectively, in the 17-OHPC group compared with placebo. The reduction in neonatal death was 68% (RR 0.32; 95% CI, 0.15-0.66; P=0.002). CONCLUSIONS: 17-OHPC could reduce the risk of recurrent preterm birth at <37, <35, and <28 weeks and neonatal death. PROSPERO: CDR42017082190.

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BACKGROUND: An indirect comparison meta-analysis published in 2013 reported that both vaginal progesterone and cerclage are equally efficacious for preventing preterm birth and adverse perinatal outcomes in women with a singleton gestation, previous spontaneous preterm birth, and a sonographic short cervix. The efficacy of vaginal progesterone has been challenged after publication of the OPPTIMUM study. However, this has been resolved by an individual patient-data meta-analysis (Am J Obstet Gynecol. 2018;218:161-180). OBJECTIVE: To compare the efficacy of vaginal progesterone and cerclage in preventing preterm birth and adverse perinatal outcomes in women with a singleton gestation, previous spontaneous preterm birth, and a midtrimester sonographic short cervix. DATA SOURCES: MEDLINE, EMBASE, LILACS, and CINAHL (from their inception to March 2018); Cochrane databases, bibliographies, and conference proceedings. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials comparing vaginal progesterone to placebo/no treatment or cerclage to no cerclage in women with a singleton gestation, previous spontaneous preterm birth, and a sonographic cervical length <25 mm. STUDY APPRAISAL AND SYNTHESIS METHODS: Updated systematic review and adjusted indirect comparison meta-analysis of vaginal progesterone vs cerclage using placebo/no cerclage as the common comparator. The primary outcomes were preterm birth <35 weeks of gestation and perinatal mortality. Pooled relative risks (RRs) with 95% confidence intervals were calculated. RESULTS: Five trials comparing vaginal progesterone vs placebo (265 women) and 5 comparing cerclage vs no cerclage (504 women) were included. Vaginal progesterone, compared to placebo, significantly reduced the risk of preterm birth <35 and <32 weeks of gestation, composite perinatal morbidity/mortality, neonatal sepsis, composite neonatal morbidity, and admission to the neonatal intensive care unit (RRs from 0.29 to 0.68). Cerclage, compared to no cerclage, significantly decreased the risk of preterm birth <37, <35, <32, and <28 weeks of gestation, composite perinatal morbidity/mortality, and birthweight <1500 g (RRs from 0.64 to 0.70). Adjusted indirect comparison meta-analyses did not show statistically significant differences between vaginal progesterone and cerclage in the reduction of preterm birth or adverse perinatal outcomes. CONCLUSION: Vaginal progesterone and cerclage are equally effective for preventing preterm birth and improving perinatal outcomes in women with a singleton gestation, previous spontaneous preterm birth, and a midtrimester sonographic short cervix. The choice of treatment will depend on adverse events and cost-effectiveness of interventions and patient/physician's preferences.

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We examined the risk of preterm birth (PTB, <37 weeks' gestation) in a second pregnancy and analyzed the extent to which this risk varies by maternal age and race/ethnicity. The sample included nulligravida mothers in California who delivered two singletons between 2005 and 2011. Logistic regression was used to calculate the odds of PTB in the second pregnancy. Within each race/ethnicity stratum, women delivering term infants in their first pregnancy and between 25 and 34 years old for both pregnancies served as the referent group. There were 2,90,834 women included in the study. Among women who delivered their first infant at term, the odds of delivering their second infant early differed by race and age. Hispanic, Black and Asian non-Hispanic women who were <18 years for both pregnancies were at higher odds of having a PTB in their second pregnancy (adjusted odds ratios 1.7, 3.3 and 2.9, respectively). Asian non-Hispanic women who were <18 years for their first delivery at term and between 18 and 24 years for their second delivery, or were >34 years for both, were also at higher odds of delivering their second baby prematurely (adjusted odds ratios 1.9 and 1.3, respectively). Women who deliver their first infant at <37 weeks of gestation are at 3 to 7 times higher odds of delivering their second infant preterm. Providers should consider including information about these risks in counseling their patients.

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Prematurity is a major public health problem in the United States and worldwide. Women with a history of a previous preterm birth are at high risk for recurrence. Progesterone is a key hormone involved in pregnancy maintenance. In general, progesterone is thought to maintain pregnancy through several closely linked mechanisms: (1) promotion of uterine quiescence, (2) inhibition of pro-inflammatory cells, and (3) immunosuppressive action. 17-Alpha hydroxyprogesterone caproate is currently the only medication approved to prevent recurrent preterm birth. The purpose of this review is to discuss the history of 17-alpha hydroxyprogesterone caproate use for recurrent preterm birth prevention, the rationale behind 17-alpha hydroxyprogesterone caproate administration, and current evidence-based indications for 17-alpha hydroxyprogesterone caproate use.

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BACKGROUND: Preterm birth (birth before 37 weeks of gestation) is a major problem in obstetrics and affects an estimated 15 million pregnancies worldwide annually. A history of previous preterm birth is the strongest risk factor for preterm birth, and recurrent spontaneous preterm birth affects more than 2.5 million pregnancies each year. A recent meta-analysis showed possible benefits of the use of low dose aspirin in the prevention of recurrent spontaneous preterm birth. We will assess the (cost-)effectiveness of low dose aspirin in comparison with placebo in the prevention of recurrent spontaneous preterm birth in a randomized clinical trial. METHODS/DESIGN: Women with a singleton pregnancy and a history of spontaneous preterm birth in a singleton pregnancy (22-37 weeks of gestation) will be asked to participate in a multicenter, randomized, double blinded, placebo controlled trial. Women will be randomized to low dose aspirin (80 mg once daily) or placebo, initiated from 8 to 16 weeks up to maximal 36 weeks of gestation. The primary outcome measure will be preterm birth, defined as birth at a gestational age (GA) < 37 weeks. Secondary outcomes will be a composite of adverse neonatal outcome and maternal outcomes, including subgroups of prematurity, as well as intrauterine growth restriction (IUGR) and costs from a healthcare perspective. Preterm birth will be analyzed as a group, as well as separately for spontaneous or indicated onset. Analysis will be performed by intention to treat. In total, 406 pregnant women have to be randomized to show a reduction of 35% in preterm birth from 36 to 23%. If aspirin is effective in preventing preterm birth, we expect that there will be cost savings, because of the low costs of aspirin. To evaluate this, a cost-effectiveness analysis will be performed comparing preventive treatment with aspirin with placebo. DISCUSSION: This trial will provide evidence as to whether or not low dose aspirin is (cost-) effective in reducing recurrence of spontaneous preterm birth. TRIAL REGISTRATION: Clinical trial registration number of the Dutch Trial Register: NTR 5675 . EudraCT-registration number: 2015-003220-31.

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BACKGROUND: 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. OBJECTIVE: 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. STUDY DESIGN: 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. RESULTS: 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). CONCLUSION: 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.

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OBJECTIVE: To evaluate the clinical utility of a novel means of assessing the cervix by measuring the angle of the curvature and to evaluate the performance of this technique as well as two other commonly used techniques of cervical length assessment in predicting spontaneous preterm birth (SPTB). METHODS: This was a retrospective cohort analysis of singleton gestations with a history of SPTB. Transvaginal ultrasound images of cervical length obtained between 20 and 23 6/7 weeks were re-measured using three techniques: (1) straight linear distance between the internal and external os, (2) sum of two contiguous linear segments tracing the internal to the external os, and (3) measurement of the angle of the curve within the cervix using an electronic protractor. A short cervical length was defined as ≤25 mm. RESULTS: A total of 181 women were included. The relative risk (RR) for SPTB by cervical angle ≤160° was 1.2 (95% CI 0.7-2.0) and the ROC curve revealed an area under the curve of 0.54 (95% CI 0.44-0.63). The RR for SPTB by short cervical length measured by the straight technique was 2.3 (95% CI 1.3-4.0) and by the segmental technique 2.1 (95% CI 1.2-3.8). There was a 99.4% agreement between the two techniques with an intraclass Kappa coefficient of 0.96. CONCLUSIONS: In women with a history of SPTB, cervical angle measurement does not correlate with the risk of SPTB. Cervical length measured via straight and segmental techniques had excellent agreement in identifying short cervix, and both identified a short cervix predictive of SPTB.

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PURPOSE: To analyze the effect of partial compliance on preterm birth (PTB) prevention among women with previous PTB and receiving 17 alpha-hydroxyprogesterone caproate (17-OHPC). STUDY DESIGN: This is a secondary analysis of a multicenter trial for the prevention of recurrent PTB. Women with prior PTB were randomly assigned between 15 0/7 and 20 3/7 weeks to weekly injections of either 17-OHPC or placebo. Full 100% compliance (group 1) was compared to 40-80% (group 2). Recurrent PTB rates and odds ratios were calculated. Student's t, Chi-square, Wilcoxon Rank-Sum, multivariate logistic regression and Breslow-Day tests were used. RESULTS: Group 1 included 370 women versus 35 in group 2. In each group, the PTB rate was significantly reduced in pregnancies receiving 17-OHPC compared to placebo. The adjusted odds ratio for PTB rate in group 1 was 0.48 (95% CI 0.31-0.75) versus 0.18 (95% CI 0.04-0.92) in group 2. Comparing the homogeneity of both odds ratios, the rates of recurrent PTB prevention in both groups were not statistically different (Breslow-Day test; p= .15). CONCLUSION: A compliance rate of 40-80% did not significantly reduce 17-OHPC's efficacy. If confirmed, our findings could lead to a dramatic decrease in costs related to prevention of recurrent PTB.

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BACKGROUND: Women with at least 1 prior occurrence of premature birth often have demographic and medical risk factors that are not modifiable. However, smoking cessation could be a targeted intervention in which a woman with a history of premature birth may be able to reduce her future risk of recurrence. OBJECTIVE: This study aims to assess how trimester-specific smoking patterns influence the risk of recurrent premature birth. STUDY DESIGN: This was a population-based retrospective cohort study of singleton nonanomalous live births in Ohio, 2006-2012 using vital statistics birth records. This analysis was limited to women with at least 1 prior premature birth. Rates of birth <37 weeks were compared among nonsmokers, women who smoked in the 3 months prior to pregnancy and quit in the first vs quit in the second vs quit in the third trimester. Multivariate logistic regression analyses assessed the association between smoking cessation at various time points in pregnancy and recurrent premature birth while adjusting for maternal race, education, Medicaid enrollment, and marital status. RESULTS: We analyzed the outcomes of 36,432 women with a prior premature birth who subsequently delivered at 20-42 weeks. One third of women with a prior premature birth smoked during pregnancy. Of smokers, 16% quit early in the first trimester, 7% quit in the second, 5% quit in the third trimester, and 72% smoked throughout pregnancy. The rate of recurrent premature birth in nonsmokers was high 28% in this cohort. Smoking in pregnancy with cessation in the first or second trimester was not significantly associated with an increase in recurrent premature birth rates (first trimester, 29% adjusted odds ratio, 0.97 [95% confidence interval, 0.9-1.1], and second trimester, 31% adjusted odds ratio, 1.10 [95% confidence interval, 0.9-1.3], respectively). However, quitting late in pregnancy (third trimester) was associated with a high rate (43%) of delivery <37 weeks, adjusted odds ratio, 1.81 (95% confidence interval, 1.48-2.21). Continued smoking throughout pregnancy was also associated with an increased recurrent premature birth (32%), adjusted odds ratio, 1.14 (95% confidence interval, 1.07-1.22), despite adjustment for concomitant premature birth risk factors. CONCLUSION: Smoking cessation in pregnancy and its relationship to preterm birth has been studied extensively, and it is widely accepted that smoking in pregnancy increases preterm birth rates. However, this study provides novel information quantifying the risk of recurrent preterm birth and stratifies the increased risk of recurrent preterm birth by trimester-specific smoking behavior. Although women with even 1 prior premature birth are at an inherently high risk of recurrence, women who stopped smoking early in the first 2 trimesters experienced similar preterm birth rates compared with nonsmokers. However, delayed smoking cessation or smoking throughout pregnancy significantly increased recurrent premature birth risk. Smoking cessation is a potential modifiable risk factor for recurrent preterm birth in high-risk pregnancies. This study highlights the importance of early pregnancy smoking cessation in those at especially high risk, women with a prior preterm birth.

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