NTR1676.
Trial name or title | TRUST (The Randomised Uterine Septum Transsection Trial) |
Methods | Multicentre randomised controlled trial |
Participants | Women with a septate uterus and a history of (recurrent) miscarriage, subfertility, or preterm birth |
Interventions | Women will be randomised to septum resection or expectant management. |
Outcomes | The primary outcome is live birth, defined as the birth of a living foetus beyond 24 weeks of gestational age. Secondary outcomes are ongoing pregnancy, clinical pregnancy, miscarriage, and complications following metroplasty. Based on retrospective studies, an improvement in the live birth rate is anticipated from 35% without surgery to 70% with surgery. |
Starting date | October 2008 |
Contact information | Judith Rikken: j.f.rikken@amc.uva.nl |
Notes | The sample size of this RCT is 68, and currently 43 women have been included. The expected final inclusion is December 2017. |
RCT: randomised controlled trial