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PC-study


- candidate number16266
- NTR NumberNTR4415
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2014
- Secondary IDsNL47362.018.13 ABR
- Public TitlePC-study
- Scientific TitlePessary or Cerclage to Prevent Preterm birth in women with short cervical length and a history preterm birth.
- ACRONYMPC-study
- hypothesis
- Healt Condition(s) or Problem(s) studiedPremature labour, Short cervical length
- Inclusion criteria1) Singleton pregnancy 2) previous preterm birth < 34 weeks of gestation 3)cervical length < 25mm OR 3) multiple preterm births
- Exclusion criteria1) Maternal age less than 18 years 2) Inability to give informed consent 3) Placenta praevia 4) Vasa praevia 5) Premature Prelabour Rupture of the Membranes (PPROM) 6) Uterine anomalies 7) Cervical dilatation 3cm 8) Cervical length <5mm 9) Identified major congenital abnormalities. 10) Women with clinical signs of chorioamnionitis or signs of intra uterine infection 11) Women whose child has signs of fetal distress defined as abnormal CTG or abnormal biophysical profile.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-mrt-2018
- Target number of participants440
- InterventionsPessary Cerclage
- Primary outcomePreterm birth < 32 weeks of gestation
- Secondary outcomeNeonatal outcomes Maternal outcomes
- TimepointsWe will need a run-in period of 3 months for the study set up, and 36 months for inclusion. After inclusion of the last patient, 6 months (additional pregnancy) will be needed for data collection and report of results. The first report on the primary outcome is expected at 4 years after the start of the study.
- Trial web sitewww.studies-obsgyn.nl/pc
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. B. Koullali
- CONTACT for SCIENTIFIC QUERIESDr. E. Pajkrt
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publicationsnone
- Brief summaryPreterm birth (PTB) is in quantity and in severity the most important pregnancy complication in obstetric care in the developed world. A cervical pessary and a cervical cerclage are both considered as potential preventive treatments for spontaneous PTB in women at increase risk due to a history of preterm birth or a short cervical length. This study evaluates the hypothesis that a cervical pessary is non-inferior to a cervical cerclage in women who are scheduled for cerclage based on their risk profile for spontaneous PTB. The study is a nationwide open-label multicenter randomized clinical trial. Eligible women will be randomized <24weeks in case of previous preterm delivery and short cervical length to either a cervical pessary or cervical cerclage or before 16 weeks in case a primary cerclage is required. Both cervical pessary and cervical cerclage will be removed at 36 weeks of GA or until delivery, whatever comes first. The primary outcome will be delivery before 32 weeks (<32 weeks). Secondary outcomes will be preterm rate birth before 24, 28, 34 and 37 weeks, time from intervention to delivery, (early) premature rupture of membranes, maternal infection, maternal side effects and composite bad neonatal outcome including both morbidity and mortality rate of children as well as costs.
- Main changes (audit trail)23-aug-2016: Inclusion NEW: 1. Singleton pregnancy

2. History of preterm birth before 34 weeks of gestation

AND

3. Cervical length of 25mm or less on transvaginal ultrasound before 24 weeks of GA

OR

Indication for primary cerclage before 16 weeks in current pregnancy based on obstetric history, according to local protocol

Exclusion NEW:
1. Maternal age less than 18 years
2. Inability to give informed consent
3. Placenta praevia
4. Vasa praevia
5. Premature Prelabour Rupture of the Membranes (PPROM)
6. Cervical dilatation ≥3cm
7. Cervical length 2mm
8. Identified major congenital abnormalities
9. Women with clinical signs of chorioamnionitis or signs of intra uterine infection
- RECORD29-jan-2014 - 23-aug-2016


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