Skip to main content Accessibility help
×
Hostname: page-component-848d4c4894-5nwft Total loading time: 0 Render date: 2024-05-01T13:44:25.660Z Has data issue: false hasContentIssue false

Chapter 22 - The future

Fetal therapy and translational studies: global alignment, coordination, and collaboration in perinatal research: The Global Obstetrics Network (GONet) initiative

from Section 2 - Fetal disease

Published online by Cambridge University Press:  05 February 2013

Mark D. Kilby
Affiliation:
Department of Fetal Medicine, University of Birmingham
Anthony Johnson
Affiliation:
Baylor College of Medicine, Texas
Dick Oepkes
Affiliation:
Department of Obstetrics, Leiden University Medical Center
Get access

Summary

Introduction

Medical interventions should only be offered if there is evidence that they help the patient. At present, there is consensus that their effectiveness should be evaluated before incorporation into guidelines.

Since the inception of fetal medicine as a subspecialty and the application of in-utero treatments for fetal therapy, there have been cohort studies presented. Initially these cohort series (mainly retrospective) were based on experiences from tertiary centers but in the last five to ten years there has been more of a focus on “population-based” cohort studies that at least have accurate denominator data from which to calculate outcomes.

Critical appraisal of the literature and appraisal of fetal therapy has been aided by performing systematic reviews and, where practicable, meta-analysis of outcomes. However, although such methods are informative they summate evidence from relatively small and often heterogeneous case cohort studies.

The randomized clinical trial is considered to be the best research tool to evaluate the effectiveness of medical interventions, and is the widely acknowledged design of choice for evaluating medical and surgical treatments [1 – 3].

Type
Chapter
Information
Fetal Therapy
Scientific Basis and Critical Appraisal of Clinical Benefits
, pp. 433 - 439
Publisher: Cambridge University Press
Print publication year: 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Altman, DG. Better reporting of randomised controlled trials: the CONSORT statement. BMJ 1996;313:5701.Google Scholar
Pocock, SJ. Clinical Trials: A Practical Approach. Chichester, Wiley, 1983.
Senn, S. Statistical Issues in Drug Development. Chichester, Wiley, 1997.
Kenyon, SL, Taylor, DJ, Tarnow-Mordi, W; ORACLE Collaborative Group. Broad-spectrum antibiotics for spontaneous preterm labour: the ORACLE II randomised trial. ORACLE Collaborative Group. Lancet 2001;357:989–94.Google Scholar
Kenyon, SL, Taylor, DJ, Tarnow-Mordi, W; ORACLE Collaborative Group. Broad-spectrum antibiotics for preterm, prelabour rupture of fetal membranes: the ORACLE I randomised trial. ORACLE Collaborative Group. Lancet 2001;357:979–88.Google Scholar
Hills, RK, Daniels, J. Assessing new interventions in women’s health. Best Pract Res Clin Obstet Gynaecol 2006;20:713–28.Google Scholar
Lasagna, L. Problems in publication of clinical trial methodology. Clin Pharmacol Ther 1979;25:751–3.Google Scholar
Raza, A, Chien, PF, Khan, KS. Multicentre randomised controlled trials in obstetrics and gynaecology: an analysis of trends over three decades. BJOG 2009;116:1130–4.Google Scholar
Kuroki, LM, Allsworth, JE, Peipert, JF. Methodology and analytic techniques used in clinical research: associations with journal impact factor. Obstet Gynecol 2009;114(4):877–84.Google Scholar
Thom, EA, Rouse, DJ; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. What we have learned about conducting randomized controlled trials in the NICHD MFMU network. Semin Perinatol 2003;27:253–60.Google Scholar
Hannah, ME, Hannah, WJ, Hewson, SA, et al. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet 2000;356:1375–83.Google Scholar
Poston, L, Briley, AL, Seed, PT, Kelly, FJ, Shennan, AH; Vitamins in Pre-eclampsia (VIP) Trial Consortium. Vitamin C and vitamin E in pregnant women at risk for pre-eclampsia (VIP trial): randomised placebo-controlled trial. Lancet 2006;367:1145–54.Google Scholar
Norman, JE, Mackenzie, F, Owen, P, et al. Progesterone for the prevention of preterm birth in twin pregnancy (STOPPIT): a randomised, double-blind, placebo-controlled study and meta-analysis. Lancet 2009;373(9680):2034–40.Google Scholar
Shennan, AH, Crawshaw, S, Briley, A, et al. A randomised controlled trial of metronidazole for the prevention of preterm birth in women positive for cervico-vaginal fetal fibronectin: the PREMET Study. BJOG 2006;113:65–74.Google Scholar
Groom, KM, Shennan, AH, Jones, BA, Seed, P, Bennett, P. Randomised double blind placebo controlled trial of rofecoxib (a cox-2 specific prostaglandin inhibitor) for the prevention of preterm delivery in women at high risk. BJOG 2005;112(6):725–30.Google Scholar
Comparative Obstetric Mobile Epidural Trial (COMET) Study Group UK. Effect of low-dose mobile versus traditional epidural techniques on mode of delivery: a randomised controlled trial. Lancet 2001;358:19–23.
Fisk, NM, Atun, R. Market failure and the poverty of new drugs in maternal health. PLoS Med 2008;5:e22.Google Scholar
Wapner, RJ Sorokin, Y, Mele, L, et al. National Institute of Child Health and Human Development Maternal-Fetal Medicine units Network. Long-term outcomes after repeat doses of antenatal cortiosteriods. N Engl J Med 2007;357:1190–8.Google Scholar
Meis, PJ, Klebanoff, M, Thom, E, et al. National Institute of Child Health and Human Development Maternal-Fetal Medicine units Network. Prevention of recurrent preterm delivery by 17-alpha hydroxyprogestrone caproate. N Engl J Med 2003;348:2379–85.Google Scholar
Lamdon, MB, Hauth, JC, Leveno, KJ, et al. National Institute of Child Health and Human Development Maternal-Fetal Medicine units Network. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med 2004;351:2581–90.Google Scholar
Magee, LA, von Dadelszen, P, Chan, S, et al. The Control of Hypertension in Pregnancy Study pilot trial. BJOG 2007;114:13–20.Google Scholar
Murphy, KE, Hannah, ME, Willan, AR, et al. Multiple courses of antenatal corticosteroids for preterm birth (MACS): a randomised controlled trial. Lancet 2008 ;372:2143–51.Google Scholar
Bakker, JJH, Verhoeven, C, Janssen, P, et al. Does internal tocodynamometry improve the outcome of labour? A randomised controlled trial comparing monitoring of contractions with an intrauterine pressure catheter to an external tocotransducer during induced or augmented labor. N Engl J Med 2010;362:306–13.Google Scholar
Koopmans, CM, Bijlenga, D, Aarnoudse, JG, et al. Induction of labour versus expectant monitoring in women with pregnancy induced hypertension or mild preeclampsia at term: the HYPITAT trial. Lancet 2009;374:979–88.Google Scholar
Mol, BW, Ruifroth, AE, for the Global obstetrics Network. Global adjustment, coordination and collaboration in perinatal research: The Global obstetrics Network (GONet initiative. Aa J Perinatol 2012: in press.Google Scholar

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×