Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial

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• 作者：Maud A Hegeman (1)
  Dick J Bekedam (1)
  Kitty WM Bloemenkamp (2)
  Anneke Kwee (3)
  Dimitri NM Papatsonis (4)
  Joris AM van der Post (5)
  Arianne C Lim (5)
  Hubertina CJ Scheepers (6)
  Christine Willekes (6)
  Johannes J Duvekot (7)
  Marc Spaanderman (8)
  Martina Porath (9)
  Jim van Eyck (10)
  Monique C Haak (11)
  Marielle G van Pampus (12)
  Hein W Bruinse (3)
  BenWillem J Mol (5)
  
• 刊名：BMC Pregnancy and Childbirth
• 出版年：2009
• 出版时间：December 2009
• 年：2009
• 卷：9
• 期：1
• 全文大小：474KB
• 参考文献：1. Bruinse HWVG: Meerlingen (Multiple Pregnancy). / Uitgeverij Elsevier/de Tijdstroom 1997.
  2. Landelijke Verloskundige Registratie 2002: Dutch obstetrical Database 2002. / Prismant 2002 2009.
  3. Landelijke Neonatale Registratie 2003: Dutch Neonatal Database 2002. / Prismant 2002 2009.
  4. Guinn DA, Atkinson MW, Sullivan L, Lee M, MacGregor S, Parilla BV, / et al.: Single vs weekly courses of antenatal corticosteroids for women at risk of preterm delivery: A randomized controlled trial. / JAMA 2001,286(13):1581鈥?. CrossRef
  5. Newcomer J: Pessaries for the treatment of incompetent cervix and premature delivery. / Obstet Gynecol Surv 2000,55(7):443鈥?. CrossRef
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  7. Goya M, Carreras E: Randomized Controlled Trial: Prevention of Preterm Birth Using Cervical Pessary in Pregnant Women With Short Cervix (PECEP). [http://clinicaltrials.gov/ct2/show/NCT00706264] 2008.
  8. Arabin B, Halbesma JR, Vork F, Hubener M, van EJ: Is treatment with vaginal pessaries an option in patients with a sonographically detected short cervix? / J Perinat Med 2003,31(2):122鈥?3. CrossRef
  9. Acharya G, Eschler B, Gronberg M, Hentemann M, Ottersen T, Maltau JM: Noninvasive cerclage for the management of cervical incompetence: a prospective study. / Arch Gynecol Obstet 2006,273(5):283鈥?. CrossRef
  10. Lim AC, Bloemenkamp KW, Boer K, Duvekot JJ, Erwich JJ, Hasaart TH, / et al.: Progesterone for the prevention of preterm birth in women with multiple pregnancies: the AMPHIA trial. / BMC Pregnancy Childbirth 2007, 7:7. CrossRef
  11. Gates S, Brocklehurst P: How should randomised trials including multiple pregnancies be analysed? / BJOG 2004,111(3):213鈥?. CrossRef
  12. Nizard J: Evaluation Of Pessaries. [http://clinicaltrials.gov/ct2/show/NCT00502190] / Twin Pregnancies With A Short Cervix (25 mm) Between 20鈥?8 WG (EPEGE) 2009.
  13. Nicolaides K: Randomized Study of Pessary vs Standard Management in Women With Increased Chance of Premature Birth. [http://clinicaltrials.gov/ct2/show/NCT00735137] 2009.
  14. The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2393/9/44/prepub
  
• 作者单位：Maud A Hegeman (1)
  Dick J Bekedam (1)
  Kitty WM Bloemenkamp (2)
  Anneke Kwee (3)
  Dimitri NM Papatsonis (4)
  Joris AM van der Post (5)
  Arianne C Lim (5)
  Hubertina CJ Scheepers (6)
  Christine Willekes (6)
  Johannes J Duvekot (7)
  Marc Spaanderman (8)
  Martina Porath (9)
  Jim van Eyck (10)
  Monique C Haak (11)
  Marielle G van Pampus (12)
  Hein W Bruinse (3)
  BenWillem J Mol (5)
  
  1. Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
  2. Department of Obstetrics and Gynaecology, Leiden University Medical Center, the Netherlands
  3. Department of Obstetrics and Gynaecology, University Medical Centre, Utrecht, the Netherlands
  4. Department of Obstetrics and Gynaecology, AMPHIA hospital, Breda, the Netherlands
  5. Department of Obstetrics and Gynaecology, Academic Medical Centre Amsterdam, Amsterdam, the Netherlands
  6. Department of Obstetrics and Gynaecology, Academic Hospital Maastricht, the Netherlands
  7. Department of Obstetrics and Gynaecology, Erasmus Medical Center Rotterdam, the Netherlands
  8. Department of Obstetrics and Gynaecology, University Medical Center St Radboud Nijmegen, the Netherlands
  9. Department of Obstetrics and Gynaecology, M谩xima Medical Center, Veldhoven, the Netherlands
  10. Department of Obstetrics and Gynaecology, Isala Hospital, Zwolle, the Netherlands
  11. Department of Obstetrics and Gynaecology, VU Medical Center, Amsterdam, the Netherlands
  12. Department of Obstetrics and Gynaecology, University Medical Center, Groningen, the Netherlands
  

文摘

Background Multiple pregnancies are at high risk for preterm birth, and therefore an important cause of infant mortality and morbidity. A pessary is a simple and potentially effective measure for the prevention of preterm birth. Small studies have indicated its effectiveness, but large studies with sufficient power on the subject are lacking. Despite this lack of evidence, the treatment is at present applied by some gynaecologists in The Netherlands. Methods/Design We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first. The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 7.2% without to 3.9% with a cervical pessary, using a two-sided test with an alpha of 0.05 and a power of 0.80. Discussion This trial will provide evidence on whether a cervical pessary will decrease the incidence of early preterm birth and its concomitant bad neonatal outcome in multiple pregnancies. Trial registration Current Controlled Trials: NTR 1858