Amniocentesis before 14 completed weeks as an alternative to transabdominal chorionic villus sampling: a controlled trial with infant follow‐up

Nagel, H; Vandenbussche, Frank P.H.A.; Keirse, M.J.N.C.; Oepkes, Dick; Oosterwijk, Jan C.; Beverstock, Geoffrey C.; Kanhai, Humphrey H.H.

doi:10.1002/(sici)1097-0223(199805)18:5<465::aid-pd325>3.0.co;2-#

Cited by 31 publications

(11 citation statements)

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“…There were 11 obstetric and 10 gynaecological studies, predominately from high-income countries (Supporting Information Table S2). With respect to design, all studies were RCTs, of which eight were partially randomised patient preference trials, [35][36][37]40,42,[44][45][46] and the others conventional RCTs. Size of studies varied (median 293, range 33-5519) with three papers involving <100 participants 29,32,33 and four involving >2000 participants.…”

Section: Characteristics and Quality Of Included Studiesmentioning

confidence: 99%

“…29,31 The quality of comparison between RCT participants and non-participants was high in 18 studies; the remaining three studies had a risk of bias in the selection and performance domains. 29,30,40…”

Section: Characteristics and Quality Of Included Studiesmentioning

confidence: 99%

“…The majority of the comparisons between trial participants and non-participants were of high quality. Several studies included in our meta-analysis were partially randomised patient preference trials, [35][36][37]40,42,[44][45][46] an approach that allows capture of a concurrent non-participant cohort with the same eligibility criteria as those within the RCT, a feature preferred over historical comparisons. 65,66 However, this design may allow for selection bias, as trial participants that are given a choice of intervention may have inherent psychological differences.…”

Section: Strengths and Limitationsmentioning

confidence: 99%

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Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis

Nijjar

D’Amico

Wimalaweera³

et al. 2017

BJOG

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Background Previous reviews examining the effect of participation in trials on outcomes have not consistently shown benefit. Obstetrics and gynaecology is a unique disease area posing challenges for both researchers and patients.Objectives To determine whether participation in randomised controlled trials (RCTs), compared with non-participation, has a beneficial effect on women's health.Search strategy Medline, Embase, the Cochrane Library, and PsycInfo were searched up to December 2015.Selection criteria We selected studies that reported the same clinical outcomes for participants in a women's health RCT and a comparable non-participant cohort.Data collection and analysis Data were extracted on quality, characteristics and study results. Outcomes were compared using logistic regression.Main results There were 21 relevant studies (20 160 women, 4759 outcome events). Trial participants, compared with nonparticipants, had 25% better odds of improved outcomes on average (OR 0.75; 95% CI 0.64-0.87; I 2 = 64.3%). The beneficial effect of participating in a trial was larger in comparisons where: RCTs were of high quality (OR 0.62; 95% CI 0.50-0.76) versus low (OR 0.92; 95% CI 0.74-1.16); and RCT intervention was not available to non-participants (OR 0.57; 95% CI 0.47-0.69) versus when it was (OR 1.13; 95% CI 0.89-1.44). The effect of trial participation was not influenced by effect size within the RCT (P = 0.48), whether funding was received or not (P = 0.13), whether non-participants received any treatment or not (P = 0.49), and the quality of the comparison of RCT participants with non-participants (P = 0.88).Conclusions Women participating in RCTs on average experienced better outcomes compared with those outside trials.Keywords Neonate, randomised, systematic review, trial participation, women's health.Tweetable abstract Participants in obstetric and gynaecology RCTs experience better outcomes compared with nonparticipants.Please cite this paper as: Nijjar SK, D'Amico MI, Wimalaweera NA, Cooper NAM, Zamora J, Khan KS. Participation in clinical trials improves outcomes in women's health: a systematic review and meta-analysis.

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Section: Characteristics and Quality Of Included Studiesmentioning

confidence: 99%

Section: Characteristics and Quality Of Included Studiesmentioning

confidence: 99%

Section: Strengths and Limitationsmentioning

confidence: 99%

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Participation in clinical trials improves outcomes in women's health: a systematic review and meta‐analysis

Nijjar

D’Amico

Wimalaweera³

et al. 2017

BJOG

View full text Add to dashboard Cite

show abstract

“…In the mid-late 1990s some programs were offering 'early amniocentesis' between 10 and 14 weeks as an alternative to CVS [23]. Subsequent data revealed that patients having an amniocentesis at less than 14 weeks 0 days, had a higher pregnancy loss rate than CVS [24].…”

Section: Historical Perspectivementioning

confidence: 99%

“…Club feet, which occur in one to three per thousand births in the general population, was seen in about 1.5% of pregnancies exposed to early amniocentesis [24]. Although the mechanism remains uncertain, studies from Europe and North America independently found that about 15% of patients undergoing the procedure had amniotic fluid leakage, and of these there was approximately a 15% risk of Talipes [23][24][25]. This high frequency of fluid loss and risk of malformation both seem to diminish once the amnion and chorion fuse at around 14 weeks.…”

Section: Historical Perspectivementioning

confidence: 99%