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ProTWIN Trial - PESSARIES IN MULTIPLE PREGNANCY AS A PREVENTION OF PRETERM BIRTH.


- candidate number5989
- NTR NumberNTR1858
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-jun-2009
- Secondary IDs50-50110-96-618 Zonmw
- Public TitleProTWIN Trial - PESSARIES IN MULTIPLE PREGNANCY AS A PREVENTION OF PRETERM BIRTH.
- Scientific TitleProTWIN Trial - PESSARIES IN MULTIPLE PREGNANCY AS A PREVENTION OF PRETERM BIRTH.
- ACRONYMProTWIN Trial
- hypothesisTo 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.
- Healt Condition(s) or Problem(s) studiedPrematurity, Pregnancy multiple, Pessary
- Inclusion criteriaMultiple pregnancy (monochorionic and bichorionic) between 12 and 20 weeks of gestation.
- Exclusion criteriaWomen with multiple pregnancies in which at least one of the fetus(es) has major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery), or death of one or both of the foetuses, as well as severe twin-to-twin transfusion syndrome diagnosed before randomization, will not be included.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-sep-2012
- Target number of participants800
- InterventionsEligible 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.
- Primary outcomeThe main outcome parameter is the composite morbidity rate of children in the two groups. This composite morbidity rate contains the following variables: severe Respiratory Distress Syndrome (RDS), Broncho Pulmonal Dysplasia (BPD), Intraventricular Haemorrhage II B or worse, Necrotizing Enterocolitis (NEC), proven sepsis and death before discharge from the nursery. They will be measured untill 10 weeks after the expected term date.
- Secondary outcomeSecondary 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.
- TimepointsDuration of the study will be 48 months:
1. We will need a run-in period of three months for the study set up;
2. Thirty-eight months for inclusion of the required number of cases;
3. Seven months for follow-up data collection and report of results.
- Trial web sitewww.studies-obsgyn.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.M.S. Liem
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG), Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIt has been suggested that the use of a cervical pessary reduces the risk of preterm delivery.In this trial eligble women will be randomly allocated to receive either a pessary or no treatment.
Treatment group: The cervical pessary will be inserted any time between 12 and 20 weeks and continued till delivery or 36 weeks gestation, whichever comes first.
Control group: No treatment for cervical incompetence will be given.
The main outcome parameter is the composite morbidity rate of children in the two groups. This composite morbidity rate contains the following variables: severe Respiratory Distress Syndrome (RDS), Broncho Pulmonal Dysplasia (BPD), Intraventricular Haemorrhage II B or worse, Necrotizing Enterocolitis (NEC), proven sepsis and death before discharge from the nursery. They will be measured untill 10 weeks after the expected term date.
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.
The effectiveness of a cervical pessary versus no treatment will be assessed by calculating relative risks and 95% confidence intervals. The sample size is calculated based on the primary outcome 'bad neonatal outcome'. On the mother level this corresponds to an expected 'bad neonatal outcome' in at least one of two children of 12.4% in the control group and 6.7% in case of treatment. Using a two-sided test with an alpha of 0.05 and a power of 0.80 we need 400 women in the control group and 400 in the intervention group.
- Main changes (audit trail)
- RECORD20-jun-2009 - 16-jan-2013


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