scholarly journals 531: Long-term effects of cervical pessary for preterm birth prevention in twin pregnancy with short cervix: a 3 years follow-up of the ProTwin trial

2016 ◽  
Vol 214 (1) ◽  
pp. S287 ◽  
Author(s):  
Janneke van 't Hooft ◽  
Cuny Cuijpers ◽  
Johanna H. van der Lee ◽  
Sophie Liem ◽  
Ewoud Schuit ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Twin Pregnancy ◽  
Long Term Effects ◽  
Short Cervix ◽  
Cervical Pessary

scholarly journals Evaluation of the Arabin cervical pessary for prevention of preterm birth in women with a twin pregnancy and short cervix (STOPPIT-2): An open-label randomised trial and updated meta-analysis

PLoS Medicine ◽  
2021 ◽  
Vol 18 (3) ◽  
pp. e1003506
Author(s):  
Jane E. Norman ◽  
John Norrie ◽  
Graeme MacLennan ◽  
David Cooper ◽  
Sonia Whyte ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Standard Care ◽  
Twin Pregnancy ◽  
Preterm Labour ◽  
Meta Analysis ◽  
Cervical Length ◽  
Open Label ◽  
Short Cervix ◽  
Link Type ◽  
Cervical Pessary

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.

scholarly journals The Kansas University DHA Outcomes Study (KUDOS) clinical trial: long-term behavioral follow-up of the effects of prenatal DHA supplementation

2019 ◽  
Vol 109 (5) ◽  
pp. 1380-1392 ◽  
Author(s):  
John Colombo ◽  
D Jill Shaddy ◽  
Kathleen Gustafson ◽  
Byron J Gajewski ◽  
Jocelynn M Thodosoff ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Preterm Birth ◽  
Visual Attention ◽  
Maternal Blood ◽  
Chain Polyunsaturated Fatty Acid ◽  
Long Term Effects ◽  
Double Blind ◽  
Early Preterm Birth

ABSTRACT Background Docosahexaenoic acid (DHA) is a long-chain polyunsaturated fatty acid that has been linked to improved vision and cognition in postnatal feeding studies and has been consistently associated with reduction of early preterm birth in prenatal supplementation trials. This is a report of the first long-term follow-up of infants from mothers receiving prenatal DHA supplementation in a US cohort. Objective Our objective was to evaluate the efficacy of the prenatal supplementation on both global and granular longitudinal assessments of cognitive and behavioral development. Methods In a randomized double-blind clinical trial, mothers received either 600 mg/d of DHA or a placebo beginning at 14.5 weeks of gestation and capsules were provided until delivery. Children from those pregnancies were followed by cognitive and behavioral assessments administered from 10 mo through 6 y of age. From 301 mothers in the initial study, ∼200 infants completed the longitudinal schedule. Results Although this intervention had been shown to reduce high-risk pregnancies and improve visual attention in infants during the first year, only a few positive long-term effects of prenatal DHA supplementation emerged from analyses of this follow-up. Increases in maternal blood DHA during pregnancy were related to verbal and full scale intelligence quotient (IQ) scores at 5 and 6 y, but these effects disappeared after controlling for SES. Maternal blood DHA concentrations at delivery were unrelated to outcomes, although maternal DHA at enrollment was related to productive vocabulary at 18 mo. Conclusions Although prenatal DHA supplementation substantially reduced early preterm birth and improved visual attention in infancy in this sample, no consistent long-term benefits were observed into childhood. Increases in maternal blood DHA concentration in pregnancy were related to higher IQs but this effect was confounded with SES and disappeared when SES was statistically controlled. This trial was registered at http://www.clinicaltrials.gov as NCT00266825 and NCT02487771.

scholarly journals Long-term follow-up of children exposed in-utero to progesterone treatment for prevention of preterm birth: study protocol of the AMPHIA follow-up

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e053066
Author(s):  
Noor E Simons ◽  
Emilie V J van Limburg Stirum ◽  
Aleid G van Wassenaer-Leemhuis ◽  
Martijn J J Finken ◽  
Cornelieke S H Aarnoudse-Moens ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Randomised Trial ◽  
Multiple Gestation ◽  
Long Term Effects ◽  
Follow Up Study ◽  
Multiple Gestations ◽  
Progesterone Treatment ◽  
Long Term Follow Up

IntroductionPreterm birth is one of the main problems in obstetrics, and the most important cause of neonatal mortality, morbidity and neurodevelopmental impairment. Multiple gestation is an important risk factor for preterm birth, with up to 50% delivering before 37 weeks. Progesterone has a role in maintaining pregnancy and is frequently prescribed to prevent (recurrent) preterm birth and improve pregnancy outcomes in high-risk patients. However, little is known about its long-term effects in multiple gestations. The objective of this follow-up study is to assess long-term benefits and harms of prenatal exposure to progesterone treatment in multiple gestations on child development.Methods and analysisThis is a follow-up study of a multicentre, double-blind, placebo-controlled randomised trial (AMPHIA trial, ISRCTN40512715). Between 2006 and 2009 women with a multiple gestation were randomised at 16–20 weeks of gestation to weekly injections 250 mg 17α-hydroxyprogesterone caproate or placebo, until 36 weeks of gestation or delivery. The current long-term follow-up will assess all children (n=1355) born to mothers who participated in the AMPHIA trial, at 11–14 years of age, with internationally validated questionnaires, completed by themselves, their parents and their teachers.Main outcomes are child cognition and behaviourAdditional outcomes are death (perinatal and up to age 14), gender identity, educational performance and health-related problems. We will use intention-to-treat analyses comparing experimental and placebo group. To adjust for the correlation between twins, general linear mixed-effects models will be used.Ethics and disseminationAmsterdam UMC MEC provided a waiver for the Medical Research Involving Human Subjects Act (W20_234#20.268). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders, patients and participants. This protocol is published before analysis of the results.Trial registration numberNL8933.

scholarly journals Pessary for prevention of preterm birth in twin pregnancy with short cervix: 3-year follow-up study

2018 ◽  
Vol 51 (5) ◽  
pp. 621-628 ◽  
Author(s):  
J. van ‘t Hooft ◽  
J. H. van der Lee ◽  
B. C. Opmeer ◽  
A. G. van Wassenaer-Leemhuis ◽  
A. L. van Baar ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Twin Pregnancy ◽  
Short Cervix ◽  
Follow Up Study

scholarly journals The course of subjective and objective chemosensory dysfunction in hospitalized patients with COVID-19: a 6-month follow-up

2021 ◽  
Author(s):  
Mattis Bertlich ◽  
Clemens Stihl ◽  
Enzo Lüsebrink ◽  
Johannes C. Hellmuth ◽  
Clemens Scherer ◽  
...  
Keyword(s):  
Long Term Effects ◽  
Initial Examination ◽  
Initial Cohort ◽  
Negative Controls ◽  
Chemosensory Function ◽  
Analogue Scales ◽  
Smell Identification ◽  
Snot 22

Abstract Purpose It has been established that the infection with SARS-CoV-2 may cause an impairment of chemosensory function. However, there is little data on the long-term effects of SARS-CoV-2 infection on chemosensory function. Methods Twenty three SARS-CoV-2-positive patients diagnosed in spring 2020 with subjective hyposmia (out of 57 positive patients, 40.3%) were compared to SARS-CoV-2-positive patients without hyposmia (n = 19) and SARS-CoV-2-negative patients (n = 14). Chemosensory function was assessed by the Brief Smell Identification Test (BSIT), Taste Strips (TS), Visual Analogue Scales (VAS), and the SNOT-22. The initial cohort with hyposmia were also examined at 8 weeks and 6 months after initial examination. Results There were no differences between the SARS-CoV-2-positive cohort without hyposmia and negative controls in terms of BSIT (8.5 ± 2.6 vs. 10.2 ± 1.8), TS (3.4 ± 0.6 vs. 3.9 ± 0.3) or VAS (2.1 ± 1.3 vs. 1.1 ± 0.5); yet the SNOT-22 was significantly elevated (27.7 ± 11.2 vs. 16.4 ± 10.8). The SARS-CoV-2-positive group with hyposmia performed significantly poorer in BSIT (4.0 ± 1.7 vs. 8.5 ± 2.6/10.2 ± 1.8), TS (2.6 ± 1.3 vs. 3.4 ± 0.6/3.9 ± 0.3), and VAS (7.9 ± 2.2 vs. 2.1 ± 1.3/1.1 ± 0.5) compared to both control groups. At week 8 and month 6 control, six and five patients, respectively, still suffered from subjectively and objectively impaired chemosensory function. The other patients had recovered in both respects. Conclusion SARS-CoV-2 patients with subjectively impaired chemosensory function regularly perform poorly in objective measurements. About 70% of patients suffering from olfactory dysfunction in SARS-CoV-2 quickly recover—the rest still suffers from considerable impairment 6 months after infection.

scholarly journals Long-term effects of a modified, low-protein infant formula on growth and body composition: Follow-up of a randomized, double-blind, equivalence trial

2021 ◽  
Author(s):  
Stefanie M.P. Kouwenhoven ◽  
Nadja Antl ◽  
Martijn J.J. Finken ◽  
Jos W.R. Twisk ◽  
Eline M. van der Beek ◽  
...  
Keyword(s):  
Body Composition ◽  
Infant Formula ◽  
Long Term Effects ◽  
Double Blind ◽  
Equivalence Trial ◽  
Low Protein

scholarly journals Long-term effects of the Dutch Schoolgruiten Project – promoting fruit and vegetable consumption among primary-school children

2009 ◽  
Vol 12 (8) ◽  
pp. 1213-1223 ◽  
Author(s):  
Nannah I Tak ◽  
Saskia J te Velde ◽  
Johannes Brug
Keyword(s):  
Primary School ◽  
Vegetable Consumption ◽  
Primary School Children ◽  
Secondary Outcome ◽  
Fruit Intake ◽  
Long Term Effects ◽  
Intervention Effects ◽  
Parent Reports

AbstractObjectivesTo evaluate the long-term effects of the Schoolgruiten Project, a Dutch primary school-based intervention providing free fruit and vegetables (F&V). In addition, we assessed whether children’s appreciation of the project mediated these intervention effects.Design and methodsParticipating schoolchildren (mean age 9·9 years at baseline) and their parents completed parallel questionnaires at baseline, at 1-year and at 2-year follow-up, including questions on usual F&V intake of the child, potential behavioural determinants, their appreciation of the project and general demographics. Primary outcomes were usual F&V intakes as assessed by parent and child self-reported food frequency measures. Secondary outcome measures were taste preference, knowledge of daily recommendations, availability and accessibility for fruit intake. Multilevel linear regression analyses were used to assess differences at second follow-up adjusted for baseline values between control and intervention groups.SubjectsReports were available for 346 intervention children (148 parents) and 425 control children (287 parents).ResultsBoth child and parent reports indicated that the intervention group had a significantly higher fruit intake at 2-year follow-up (difference, servings/d: 0·15; 95 % CI 0·004, 0·286 for child reports; 0·19; 95 % CI 0·030, 0·340 for parent reports). No significant effects on vegetable intake were observed. Significant positive intervention effects were also found for knowledge of fruit recommendations among boys. Some evidence was found for partial mediation analyses of the effects on fruit intake.ConclusionThe present study indicates that the Schoolgruiten scheme was effective in increasing children’s fruit intake and that appreciation of the project partially mediated this effect.

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