Cervical Pessary for Preventing Preterm Birth in Singleton Pregnancies With Short Cervical Length: A Systematic Review and Meta-analysis

2017 ◽  
Vol 36 (8) ◽  
pp. 1535-1543 ◽  
Author(s):  
Gabriele Saccone ◽  
Andrea Ciardulli ◽  
Serena Xodo ◽  
Lorraine Dugoff ◽  
Jack Ludmir ◽  
...  
2017 ◽  
Vol 30 (24) ◽  
pp. 2918-2925 ◽  
Author(s):  
Gabriele Saccone ◽  
Andrea Ciardulli ◽  
Serena Xodo ◽  
Lorraine Dugoff ◽  
Jack Ludmir ◽  
...  

PLoS Medicine ◽  
2021 ◽  
Vol 18 (3) ◽  
pp. e1003506
Author(s):  
Jane E. Norman ◽  
John Norrie ◽  
Graeme MacLennan ◽  
David Cooper ◽  
Sonia Whyte ◽  
...  

Background Preterm-labour-associated preterm birth is a common cause of perinatal mortality and morbidity in twin pregnancy. We aimed to test the hypothesis that the Arabin pessary would reduce preterm-labour-associated preterm birth by 40% or greater in women with a twin pregnancy and a short cervix. Methods and findings We conducted an open-label randomised controlled trial in 57 hospital antenatal clinics in the UK and Europe. From 1 April 2015 to 14 February 2019, 2,228 women with a twin pregnancy underwent cervical length screening between 18 weeks 0 days and 20 weeks 6 days of gestation. In total, 503 women with cervical length ≤ 35 mm were randomly assigned to pessary in addition to standard care (n = 250, mean age 32.4 years, mean cervical length 29 mm, with pessary inserted in 230 women [92.0%]) or standard care alone (n = 253, mean age 32.7 years, mean cervical length 30 mm). The pessary was inserted before 21 completed weeks of gestation and removed at between 35 and 36 weeks or before birth if earlier. The primary obstetric outcome, spontaneous onset of labour and birth before 34 weeks 0 days of gestation, was present in 46/250 (18.4%) in the pessary group compared to 52/253 (20.6%) following standard care alone (adjusted odds ratio [aOR] 0.87 [95% CI 0.55–1.38], p = 0.54). The primary neonatal outcome—a composite of any of stillbirth, neonatal death, periventricular leukomalacia, early respiratory morbidity, intraventricular haemorrhage, necrotising enterocolitis, or proven sepsis, from birth to 28 days after the expected date of delivery—was present in 67/500 infants (13.4%) in the pessary group compared to 76/506 (15.0%) following standard care alone (aOR 0.86 [95% CI 0.54–1.36], p = 0.50). The positive and negative likelihood ratios of a short cervix (≤35 mm) to predict preterm birth before 34 weeks were 2.14 and 0.83, respectively. A meta-analysis of data from existing publications (4 studies, 313 women) and from STOPPIT-2 indicated that a cervical pessary does not reduce preterm birth before 34 weeks in women with a short cervix (risk ratio 0.74 [95% CI 0.50–1.11], p = 0.15). No women died in either arm of the study; 4.4% of babies in the Arabin pessary group and 5.5% of babies in the standard treatment group died in utero or in the neonatal period (p = 0.53). Study limitations include lack of power to exclude a smaller than 40% reduction in preterm labour associated preterm birth, and to be conclusive about subgroup analyses. Conclusions These results led us to reject our hypothesis that the Arabin pessary would reduce the risk of the primary outcome by 40%. Smaller treatment effects cannot be ruled out. Trial registration ClinicalTrials.gov ISRCTN 02235181. ClinicalTrials.gov NCT02235181.


2018 ◽  
Vol 73 (1) ◽  
pp. 13-14 ◽  
Author(s):  
Gabriele Saccone ◽  
Andrea Ciardulli ◽  
Serena Xodo ◽  
Lorraine Dugoff ◽  
Jack Ludmir ◽  
...  

2019 ◽  
Vol 220 (1) ◽  
pp. S371 ◽  
Author(s):  
Johanna Quist-Nelson ◽  
Annemijn A. de Ruigh ◽  
Nancy Medley ◽  
Ewoud Schuit ◽  
Eva Pajkrt ◽  
...  

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
N Marconi ◽  
C Allen ◽  
S Bhattacharya ◽  
A Maheshwari

Abstract Study question Are obstetric/perinatal outcomes different in singleton pregnancies following blastocyst-stage embryo transfer when compared to cleavage-stage embryo transfer and have results changed over time? Summary answer Pregnancies following blastocyst are consistently associated with higher risk of large for gestational age and lower risk of small for gestational age babies What is known already Extended embryo culture to blastocyst-stage is widely used to select best embryos in in vitro fertilisation (IVF) cycles to improve pregnancy rates. Transfer of blastocyst-stage embryos is increasing with this being the default strategy in most clinics. As blastocysts are kept in culture until day 5, 6 or 7 after oocyte fertilisation, there are suggestions that longer exposure to culture media may have a negative impact on pregnancy outcomes. More recent primary studies have challenged some of the initial findings. We therefore conducted an updated systematic review and cumulative meta-analysis (CMA) to examine if these results have changed over time. Study design, size, duration Systematic review of studies published between 1980 and 2020, followed by aggregated meta-analysis and CMA to track the accumulation of evidence over the period of time. Exposed group: singleton pregnancies following blastocyst transfer. Non-exposed group: singleton pregnancies following cleavage-stage transfer. Sub-group analyses were conducted on fresh and frozen-thawed embryo transfers. Perinatal (categories of preterm birth and birth weight) and obstetric outcomes (hypertensive disorders of pregnancy, gestational diabetes, c-section, placental anomalies) were compared between the groups. Participants/materials, setting, methods Medline, EMBASE, CINHAL, Web of Science, Cochrane Central Register of Clinical Trials and International Clinical Trials Registry Platform databases were searched. Relevant journals were searched for advance access publications. Critical Appraisal Skills Programme (CASP) checklists were used to assess study quality. Two independent reviewers extracted data in 2 × 2 tables. Aggregated and CMA were performed using Comprehensive Meta-Analysis software. Risk ratio (RR) with 95% confidence interval (CI) were calculated. Main results and the role of chance A total of 33 observational studies were included (n = 574,756 singleton pregnancies). Pregnancies following blastocyst-stage embryo transfer are associated with a higher risk of preterm birth (PTB) (RR 1.09; 95% CI 1.01–1.17), very preterm birth (VPTB) (RR 1.15; 95% CI 1.07–1.24), large for gestational age (LGA) babies (RR 1.13; 95% CI 1.08–1.19), c-section (RR 1.05; 95% CI 1.02–1.09), and with a lower risk of small for gestational age (SGA) babies (RR 0.86; 95% CI 0.81–0.93) as compared to singleton pregnancies following cleavage-stage embryo transfer. These findings were maintained in both fresh and frozen-thawed sub-groups for LGA and SGA. PTB was not significantly different in both sub-group analyses. The risk of VPTB was higher after blastocyst-stage embryo transfer only in the sub-group analysis of fresh embryo transfers (RR 1.17; 95% CI 1.09–1.27) and that of c-section only in the frozen-thawed sub-group (RR 1.08; 95% CI 1.04–1.12). No other statistically significant differences for the other outcomes were noted. The CMA suggests that for SGA and LGA subsequent studies have increased the precision of the point estimate with no change in the direction or magnitude of the treatment effect since 2014. Limitations, reasons for caution This analysis was constrained by the intrinsic limitations of observational studies with some of them receiving a CASP score < 10. Adjustment for confounders was not possible and a high degree of clinical and statistical heterogeneity was noted among studies. Wider implications of the findings: Blastocyst is associated with a higher risk of LGA and a lower risk of SGA with a stable body of evidence since 2014. We may need to revisit the default position of extending embryo culture and individualise care, until further high-quality data from individual-patient-data of large registries are available. Trial registration number Not applicable


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