search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


The Randomised Uterine Septum Transsection Trial.


- candidate number5332
- NTR NumberNTR1676
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-feb-2009
- Secondary IDsNL24082.018.08 MEC Academisch Medisch Centrum (Amsterdam)
- Public TitleThe Randomised Uterine Septum Transsection Trial.
- Scientific TitleThe Randomised Uterine Septum Transsection Trial.
- ACRONYMTRUST
- hypothesisMetroplasty in women with recurrent miscarriage and a septate uterus will improve their reproductive outcome.
- Healt Condition(s) or Problem(s) studiedSeptate uterus, Uterine anomalies, Recurrent miscarriage, Hysteroscopic metroplasty
- Inclusion criteria1. Women with two or more preceding miscarriages before 20 weeks of gestational age and a septate uterus;
2. An uterine septum with a minimal length of 1/4 of the uterine cavity measured at HSG;
3. An active wish to conceive.
- Exclusion criteria1. Prior randomisation in the TRUST;
2. Contraindications for surgery.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2008
- planned closingdate1-jan-2018
- Target number of participants68
- InterventionsHysteroscopic metroplasty.
- Primary outcomeLive birth rate (defined as a live birth after 24 weeks of gestational age).
- Secondary outcome1. Complications following hysteroscopic metroplasty;
2. Obstetrical complications.
- TimepointsNo interim analysis has been planned.
- Trial web sitewww.studies-obsgyn.nl/TRUST
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. J.F.W. Rikken
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryIt is recognized that the prevalence of the septate uterus is increased in women with recurrent miscarriage and subfertility. At present the finding of a septate uterus in women with an active wish to conceive is not an indication for surgical correction of the septum (metroplasty). It is questionable if metroplasty will improve reproductive outcome in these patients.
Objective: This study aims to answer the question whether hysteroscopic metroplasty will improve reproductive outcome in women with recurrent miscarriage or subfertility and a septate uterus.
- Main changes (audit trail)10-okt-2014:
Women with subfertility are now also added to the inclusion criteria.
Hypothesis: metroplasty in women with recurrent miscarriage or subfertility and a septate uterus will improve reproductive outcome.
The inclusion criteria have been changed to:
- Suspicion of a septate uterus
- Active wish to conceive
[AB]

27-nov-2016:
The inclusion criteria have been extended to women with
- (recurrent) miscarriage, subfertility or preterm birth
- Diagnosis of a septate uterus
- RECORD18-feb-2009 - 27-nov-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl