| - candidate number | 5332 |
| - NTR Number | NTR1676 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 18-feb-2009 |
| - Secondary IDs | NL24082.018.08 MEC Academisch Medisch Centrum (Amsterdam) |
| - Public Title | The Randomised Uterine Septum Transsection Trial. |
| - Scientific Title | The Randomised Uterine Septum Transsection Trial. |
| - ACRONYM | TRUST |
| - hypothesis | Metroplasty in women with recurrent miscarriage and a septate uterus will improve their reproductive outcome. |
| - Healt Condition(s) or Problem(s) studied | Septate uterus, Uterine anomalies, Recurrent miscarriage, Hysteroscopic metroplasty |
| - Inclusion criteria | 1. 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 criteria | 1. Prior randomisation in the TRUST; 2. Contraindications for surgery. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-okt-2008 |
| - planned closingdate | 1-jan-2018 |
| - Target number of participants | 68 |
| - Interventions | Hysteroscopic metroplasty. |
| - Primary outcome | Live birth rate (defined as a live birth after 24 weeks of gestational age). |
| - Secondary outcome | 1. Complications following hysteroscopic metroplasty; 2. Obstetrical complications. |
| - Timepoints | No interim analysis has been planned. |
| - Trial web site | www.studies-obsgyn.nl/TRUST |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Drs. J.F.W. Rikken |
| - CONTACT for SCIENTIFIC QUERIES | Prof. B.W.J. Mol |
| - Sponsor/Initiator | Academic Medical Center (AMC), Amsterdam |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Amsterdam |
| - Publications | N/A |
| - Brief summary | It 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 |
| - RECORD | 18-feb-2009 - 27-nov-2016 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl