|- candidate number||15557|
|- NTR Number||NTR4210|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-okt-2013|
|- Secondary IDs||NL45479.018.13 ABR/METC|
|- Public Title||Apostel VI - Will a cervical pessary prolong pregnancy in women after an episode of threatened preterm labor.|
|- Scientific Title||Apostel VI - Will a cervical pessary prolong pregnancy in women after an episode of threatened preterm labor: a randomized trial.|
|- ACRONYM||APOSTEL VI|
|- hypothesis||Women who remained undelivered after an episode of threatened preterm are at increased risk for preterm labor, half of these women will eventually deliver prematurely. No treatment is currently available for these women. This study will investigate if a cervical pessary is a solution for these high risk women, by supporting the cervix and to prolong pregnancy.|
|- Healt Condition(s) or Problem(s) studied||Pregnancy, Preterm birth|
|- Inclusion criteria||-singleton/twin pregnancy|
-GA between 26+0 and 34+6
Cervical length >15mm-<30mm and positive fibronectine
-Cervical length <15 mm
-Who remained undelivered after 24 hours
|- Exclusion criteria||-Major fetal adnormalities |
-Signs of intra-uterine infection
-Sings of fetal distress
-Cervical dilatation > 3 cm
-Cervical length <5mm (48 hours after admission)
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||16-okt-2013|
|- planned closingdate||16-okt-2015|
|- Target number of participants||200|
|- Interventions||Eligible women will be randomly allocated to receive either a cervical pessary or no intervention.
The cervical pessary will be placed in situ when undelivered, 48 hours after an episode of threatened preterm labor and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.|
|- Primary outcome||Preterm delivery <37 weeks of gestation. |
|- Secondary outcome||Neonatal outcomes; composite of neonatal morbidity (e.g. RDS, BPD, IVH, NEC, PVL, sepsis) and death.
Delivery outcomes: e.g. GA at delivery, time to delivery and preterm birth rates <34 and <32 weeks.
Maternal outcomes: side-effects, complications of pessary|
|- Timepoints||Duration of the study will be 33 months:
1. We will need a run-in period of three months for the study set up;|
2. Twenty-four months for inclusion of the required number of cases;
3. 6 months for follow-up data collection and report of results.
|- Trial web site||http://www.studies-obsgyn.nl/apostel6/page.asp?page_id=1511|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| F.J.R. Hermans|
|- CONTACT for SCIENTIFIC QUERIES||Dr. M. Kok |
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary||Preterm labor is still the major contributor of perinatal morbidity and mortality.
Threatened preterm labor affects 9% of all pregnancies. Cervical length measurement and fibronectin or ACTIM-partus test can detect women who are unlikely to deliver. Of the other group a small percentage will delivery during the first admission for threatened preterm labor. For the women who remained undelivered, the risk of preterm birth is increased up to 50%. No treatment is currently available. By supporting the cervix, a pessary could prevent preterm birth or reduce the severity of prematurity and thereby the associated neonatal outcome.
|- Main changes (audit trail)||29-jul-2014: Amendment added: |
-GA between 24+0 and 34+6 weeks
-cervical length <15 mm OR >=15mm and < 30mm with a positive fibronectin
-undelivered after 48 hours
-major fetal abnormalities
-signs of intra-uterine infection
-cervical dilatation > 3cm
-cervical length <5mm (at randomisation)
-randomisation >72 hours after becoming eligible
Funding: ZonMW" - AB
12-mei-2017 - MT:
16-12-2015 approved amendement:
o exclusion criteria “cervical length at randomisation < 5mm” changed in: “Residual cervical length that makes it impossible to place a pessary”.
o Target number of participants “200” changed in : “200 singleton pregnancies”.
6 september 2016: Study halted on the advice of the DSMC based on the results of the interim analysis.
|- RECORD||16-okt-2013 - 12-mei-2017|