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Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial
- Source :
- BMC Pregnancy and Childbirth, 9:44. BMC, BMC Pregnancy and Childbirth, 9, 44-44, BMC Pregnancy and Childbirth, 9. BioMed Central Ltd., BMC Pregnancy and Childbirth, BMC pregnancy and childbirth, 9(1). BioMed Central, BMC Pregnancy and Childbirth, Vol 9, Iss 1, p 44 (2009), Hegeman, A M, Bekedam, D J, Bloemenkamp, K W M, Kwee, A, Papatsonis, D N M, van der Post, J A M, Lim, A C, Scheepers, H C J, Willekes, C, Duvekot, J J, Spaanderman, M E A, Porath, M M, van Eyck, J, Haak, M C, van Pampus, M G, Bruinse, H W & Mol, B W J 2009, ' Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial ', BMC Pregnancy and Childbirth, vol. 9, pp. 44 . https://doi.org/10.1186/1471-2393-9-44, BMC Pregnancy and Childbirth, 9. BioMed Central, BMC Pregnancy and Childbirth, 9, pp. 44-44
- Publication Year :
- 2009
- Publisher :
- Springer Science and Business Media LLC, 2009.
-
Abstract
- Contains fulltext : 79491.pdf (Publisher’s version ) (Open Access) 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.
- Subjects :
- CERVIX
Cervical pessary
Pessary
medicine.medical_specialty
Pediatrics
Health aging / healthy living [IGMD 5]
Cost-Benefit Analysis
Twins
Reproductive medicine
lcsh:Gynecology and obstetrics
Study Protocol
DELIVERY
Clinical Protocols
Pregnancy
Obstetrics and Gynaecology
Outcome Assessment, Health Care
medicine
Humans
Cervix
lcsh:RG1-991
Netherlands
Obstetrics
business.industry
Obstetrics and Gynecology
Pessaries
medicine.disease
Cervical Length Measurement
Human Reproduction [NCEBP 12]
Treatment Outcome
medicine.anatomical_structure
Research Design
Premature birth
Pregnancy Trimester, Second
Premature Birth
Gestation
Female
Pregnancy, Multiple
business
Subjects
Details
- ISSN :
- 14712393
- Volume :
- 9
- Database :
- OpenAIRE
- Journal :
- BMC Pregnancy and Childbirth
- Accession number :
- edsair.doi.dedup.....4836131a5580f2c7cd7d2b88caa8668a