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Quadruple P


- candidate number16265
- NTR NumberNTR4414
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2014
- Secondary IDsNL 42926.018.13 ABR
- Public TitleQuadruple P
- Scientific TitlePessary or Progesterone to Prevent Preterm birth in women with short cervical length
- ACRONYMQuadruple P
- hypothesis
- Healt Condition(s) or Problem(s) studiedPessary, Progesterone, Cervical length, Premature labour, Prevention
- Inclusion criteria1. Singleton pregnancy and cervical length at 18 to 20 weeks of 35 mm or less (≤35mm) OR 2. Twin pregnancy and cervical length at 16 to 20 weeks of 38 mm or less (≤38mm)
- Exclusion criteria1. Placenta previa 2. Cervical cerclage in this pregnancy 3. Maternal age less than 18 years 4. Identified major congenital abnormalities 5. Death of one or both of the foetuses 6. Previous preterm birth, for singleton pregnancies 7. Participation Quadruple P study in previous pregnancy 8. Cervical length < 5 mm 9. Cervical dilation 3cm
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2014
- planned closingdate1-jun-2018
- Target number of participants1020
- InterventionsPessary vs. Progesterone
- Primary outcomeComposite adverse neonatal outcome
- Secondary outcomeSecondary outcome measures are time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, e.g. thrombo-embolic complications, infections, pneumonia, endometritis, eclampsia/HELLP, maternal death and admission days for preterm labour.
- 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, 9 months (additional pregnancy + post-partum period) 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/quadruplep
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M.D. van Zijl
- CONTACT for SCIENTIFIC QUERIESDr. E. Pajkrt
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Achmea
- PublicationsNone
- Brief summaryPreterm birth is in quantity and in severity the most important issue in obstetric care in the developed world. Progestagens and cervical pessaries are both considered as potential preventive treatments. We aim to compare the effectiveness of vaginal progesterone and cervical pessary in the prevention of preterm birth in women with singleton and twin pregnancies with a short cervix. This study is a nationwide open-label multicenter randomized clinical trial with an economic analysis alongside it. Women with a singleton or twin pregnancy undergoing foetal assessment, at 18-22 weeks for singleton pregnancy and 16-22 weeks for multiple pregnancies, will be offered cervical length measurement. Women with a short cervix (singleton pregnancy 35 mm or less (11.5th percentile), multiple pregnancy less than 38 mm (25th percentile), will be invited to participate in a randomized clinical trial. Intervention are either daily progesterone 200mg which will be self-administered vaginally from time of randomization or the silicone cervical pessary which will be placed between 18-22 weeks for singletons or between 16-22 weeks for multiples. Both interventions will be applied until 36 weeks gestation or until delivery, whatever comes first. Primary outcome will be composite adverse neonatal outcome including both morbidity and mortality rate of children in the two groups. Secondary outcomes will be time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and cost.
- Main changes (audit trail)1-6-2017 -MT
Inclusion criteria replaced by:
1. Singleton pregnancy and cervical length at 18 to 22 weeks of 35 mm or less (≤35mm) OR
2. Multiple pregnancy and cervical length at 16 to 22 weeks of less than 38 mm (<38mm)

Exclusion criteria replaced by
1. Cervical cerclage in this pregnancy 2. Maternal age less than 18 years 3. Identified major congenital abnormalities 4. Death of one or both of the foetuses 5. Previous spontaneous preterm birth before 34 weeks 6. Participation Quadruple P study in previous pregnancy 7. Cervical length < 2 mm 9. Cervical dilation >3cm

Secondary outcome replaced by:
Secondary outcome measures are time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, birth weight, days of admission in neonatal intensive care unit, premature rupture of the membranes (PPROM), tocolysis (duration), use of corticosteroids, use of magnesium sulphate, mode of delivery, Twin Transfusion Syndrome (TTS), maternal morbidity, e.g. thrombo-embolic complications, infections, pneumonia, endometritis, eclampsia/HELLP, maternal death and admission days for preterm labour.
In addition, all components of the primary outcome will also be assessed separately as a secondary outcome measure. A cost-effectiveness analysis will be performed and reported separately from the primary trial results
- RECORD29-jan-2014 - 1-jun-2017


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