scholarly journals 17-Hydroxyprogesterone Caproate for the Prevention of Recurrent Preterm Birth – A Systematic Review and Meta-analysis Taking into Account the PROLONG Trial

2021 ◽  
Vol 81 (01) ◽  
pp. 61-69
Author(s):  
Ruben-J. Kuon ◽  
Richard Berger ◽  
Werner Rath
Keyword(s):  
Risk Factors ◽  
Preterm Birth ◽  
Meta Analysis ◽  
Selection Criterion ◽  
Subsequent Pregnancy ◽  
Controlled Study ◽  
Spontaneous Preterm Birth ◽  
Number Of Patients ◽  
Hydroxyprogesterone Caproate ◽  
17 Hydroxyprogesterone

Abstract Background Prior spontaneous preterm birth is a strong risk factor for the recurrence of spontaneous preterm birth in a subsequent pregnancy and has been evaluated in prevention studies using progesterone (natural progesterone administered orally or vaginally, and 17-hydroxyprogesterone caproate [17-OHPC]) as a selection criterion. Based on the findings of a randomized, placebo-controlled study, 17-OHPC was approved for use in 2011 by the Food and Drug Administration in the USA for the prevention of recurrent preterm birth. The approval was granted with qualification that a subsequent confirmatory study would need to be carried out, the results of which have just been published (PROLONG trial). Method A systematic literature search for the period from 1970 to April 2020 using the search terms “preterm birth” and “17-OHPC” or “progesterone” was carried out. Only randomized, placebo-controlled studies of women with singleton pregnancies who received 17-OHPC to prevent recurrent preterm birth were included in the subsequent meta-analysis. The relative risk and associated 95% confidence intervals were calculated. The heterogeneity between studies was evaluated with I2 statistics. Results In addition to the original study used for the approval and the PROLONG trial, only one other study was found which met the inclusion criteria (total number of patients: 2221). With considerable heterogeneity between the studies, particularly with respect to the risk factors for preterm birth, the comparison between 17-OHPC and placebo showed no significant reduction in preterm birth rates before 37, 35 and 32 weeks of gestation and no significant differences with regard to the prevalence of miscarriage before 20 weeks of gestation or fetal deaths (antepartum or intrapartum) after 20 weeks of gestation and neonatal morbidity. Conclusion Based on the currently available data, 17-OHPC cannot be recommended for the prevention of recurrent preterm birth. Further randomized, placebo-controlled studies with clearly defined, comparable risk factors are required to identify the group of pregnant women which could benefit from the use of 17-OHPC to prevent preterm birth.

Use of 17-Hydroxyprogesterone Caproate in Twin Gestations With a Prior Singleton Spontaneous Preterm Birth [30T]

2019 ◽  
Vol 133 (1) ◽  
pp. 221S-221S
Author(s):  
Andrew R. Ward ◽  
Victoria Rachel Greenberg ◽  
Breanna Valcarcel ◽  
Huda Bachir Al-Kouatly ◽  
Vincenzo Berghella
Keyword(s):  
Preterm Birth ◽  
Spontaneous Preterm Birth ◽  
Hydroxyprogesterone Caproate ◽  
17 Hydroxyprogesterone

scholarly journals A prognostic model, including quantitative fetal fibronectin, to predict preterm labour: the QUIDS meta-analysis and prospective cohort study

2021 ◽  
Vol 25 (52) ◽  
pp. 1-168
Author(s):  
Sarah J Stock ◽  
Margaret Horne ◽  
Merel Bruijn ◽  
Helen White ◽  
Robert Heggie ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cohort Study ◽  
Preterm Birth ◽  
Prospective Cohort ◽  
Prognostic Model ◽  
Preterm Labour ◽  
Meta Analysis ◽  
Health Technology ◽  
Spontaneous Preterm Birth ◽  
Fetal Fibronectin

Background The diagnosis of preterm labour is challenging. False-positive diagnoses are common and result in unnecessary, potentially harmful treatments (e.g. tocolytics, antenatal corticosteroids and magnesium sulphate) and costly hospital admissions. Measurement of fetal fibronectin in vaginal fluid is a biochemical test that can indicate impending preterm birth. Objectives To develop an externally validated prognostic model using quantitative fetal fibronectin concentration, in combination with clinical risk factors, for the prediction of spontaneous preterm birth and to assess its cost-effectiveness. Design The study comprised (1) a qualitative study to establish the decisional needs of pregnant women and their caregivers, (2) an individual participant data meta-analysis of existing studies to develop a prognostic model for spontaneous preterm birth within 7 days in women with symptoms of preterm labour based on quantitative fetal fibronectin and clinical risk factors, (3) external validation of the prognostic model in a prospective cohort study across 26 UK centres, (4) a model-based economic evaluation comparing the prognostic model with qualitative fetal fibronectin, and quantitative fetal fibronectin with cervical length measurement, in terms of cost per QALY gained and (5) a qualitative assessment of the acceptability of quantitative fetal fibronectin. Data sources/setting The model was developed using data from five European prospective cohort studies of quantitative fetal fibronectin. The UK prospective cohort study was carried out across 26 UK centres. Participants Pregnant women at 22+0–34+6 weeks’ gestation with signs and symptoms of preterm labour. Health technology being assessed Quantitative fetal fibronectin. Main outcome measures Spontaneous preterm birth within 7 days. Results The individual participant data meta-analysis included 1783 women and 139 events of spontaneous preterm birth within 7 days (event rate 7.8%). The prognostic model that was developed included quantitative fetal fibronectin, smoking, ethnicity, nulliparity and multiple pregnancy. The model was externally validated in a cohort of 2837 women, with 83 events of spontaneous preterm birth within 7 days (event rate 2.93%), an area under the curve of 0.89 (95% confidence interval 0.84 to 0.93), a calibration slope of 1.22 and a Nagelkerke R 2 of 0.34. The economic analysis found that the prognostic model was cost-effective compared with using qualitative fetal fibronectin at a threshold for hospital admission and treatment of ≥ 2% risk of preterm birth within 7 days. Limitations The outcome proportion (spontaneous preterm birth within 7 days of test) was 2.9% in the validation study. This is in line with other studies, but having slightly fewer than 100 events is a limitation in model validation. Conclusions A prognostic model that included quantitative fetal fibronectin and clinical risk factors showed excellent performance in the prediction of spontaneous preterm birth within 7 days of test, was cost-effective and can be used to inform a decision support tool to help guide management decisions for women with threatened preterm labour. Future work The prognostic model will be embedded in electronic maternity records and a mobile telephone application, enabling ongoing data collection for further refinement and validation of the model. Study registration This study is registered as PROSPERO CRD42015027590 and Current Controlled Trials ISRCTN41598423. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 52. See the NIHR Journals Library website for further project information.

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 Magnitude of spontaneous preterm birth and its associated factors among preterm birth in NICU wards in Asella Teaching and Referral Hospital, Asella, Oromia, Ethiopia

2021 ◽  
Vol 49 (8) ◽  
pp. 030006052110346
Author(s):  
Techane Sisay Tuji ◽  
Addisu Dabi Wake ◽  
Gezahegn Badeg Adere ◽  
Aselefu Beka Wedajo ◽  
Batu Dekeba Obole ◽  
...  
Keyword(s):  
Risk Factors ◽  
Preterm Birth ◽  
Healthcare Providers ◽  
Preterm Births ◽  
Cross Sectional Study ◽  
Spontaneous Preterm Birth ◽  
Related Factors ◽  
Cross Sectional ◽  
Bivariate Logistic Regression ◽  
Associated Risk Factors

Objective To assess the prevalence of spontaneous preterm births and to identify the associated risk factors. Methods This single-centre cross-sectional study enrolled women that experienced a preterm birth as registered on the neonatal log-book between 30 December 2019 and 30 December 2020. A pre-tested structured checklist was used to collect data (sociodemographic characteristics; obstetric-related factors; medical history; and pregnancy-related factors). Bivariate logistic regression analyses were applied to identify factors associated with spontaneous preterm birth. A multivariate model identified significant independent risk factors. Results A total of 310 patients participated in the study. The prevalence of spontaneous preterm birth in this population was 67.1% (208 of 310; 95% confidence interval [CI] 61.5, 71.9). Patients without a partner (adjusted odds ratio [AOR] = 1.470, 95% CI 1.23, 4.42), patients residing in a rural area (AOR = 2.51, 95% CI 1.123, 5.513) and those with a history of PIH during their current pregnancy (AOR = 0.104, 95% CI 0.053, 0.014) were significantly more likely to have a spontaneous preterm birth. Conclusion The prevalence of spontaneous preterm birth in in this study was high. Healthcare providers and all stakeholders should focus on screening pregnant women at the risk of spontaneous preterm birth.

scholarly journals Association between maternal sleep duration and quality, and the risk of preterm birth: a systematic review and meta-analysis of observational studies

2020 ◽  
Author(s):  
ling wang ◽  
Feng Jin
Keyword(s):  
Systematic Review ◽  
Preterm Birth ◽  
Sleep Quality ◽  
Sleep Duration ◽  
Meta Analysis ◽  
Controlled Study ◽  
Poor Sleep ◽  
Poor Sleep Quality ◽  
Increased Risk ◽  
Study Heterogeneity

Abstract Background : To assess the association of sleep duration and quality with the risk of preterm birth. Methods : Relevant studies were retrieved from the PubMed and Web of Science databases up to September 30, 2018. The reference lists of the retrieved articles were reviewed. Random effects models were applied to estimate summarized relative risks (RRs) and 95% confidence intervals (CIs). Results : Ten identified studies (nine cohort studies and one case-controlled study) examined the associations of sleep duration and quality with the risk of preterm birth. As compared with women with the longest sleep duration, the summary RR was 1.23 (95% CI = 1.01–1.50) for women with the shortest sleep duration, with moderate between-study heterogeneity ( I 2 = 57.4%). Additionally, as compared with women with good sleep quality, the summary RR was 1.54 (95% CI = 1.18–2.01) for women with poor sleep quality (Pittsburgh Sleep Quality Index > 5), with high between-study heterogeneity ( I 2 = 76.7%). Funnel plots as well as the Egger’s and Begg’s tests revealed no evidence of publication bias. Conclusions : This systematic review and meta-analysis revealed that short sleep duration and poor sleep quality may be associated with an increased risk of preterm birth. Further subgroup analyses are warranted to test the robustness of these findings as well as to identify potential sources of heterogeneity.

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