This study will answer the question whether surgical intervention (metroplasty) in women with recurrent miscarriage and/or subfertility and a septate uterus will improve their reproductive outcome.
ID
Source
Brief title
Condition
- Abortions and stillbirth
- Congenital reproductive tract and breast disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is live birth rate in each treatment group.
Secondary outcome
Secondary outcomes are complications following hysteroscopic metroplasty;
uterine perforation, fluid overload, endometritis, clinical pregnancy and
miscarriage. In a subsequent pregnancy, we will look at the prevalence of
adversary pregnancy outcomes, placental abruption, premature delivery, uterine
rupture, and mode of delivery (vaginal vs. caesarean section).
Background summary
It is recognized that the prevalence of the septate uterus is increased in
women with recurrent miscarriage.
At present the finding of a septate uterus in women with recurrent miscarriage
is not an indication for surgical correction of the septum.
The role of hysteroscopic metroplasty in patients with a septate uterus and
subfertility has neither been evaluated properly. The current literature
regarding the incidence and probable causes of subfertility among women with
congenital uterine anomalies is insufficient to allow any robust conclusions to
be drawn.
Whether hysteroscopic metroplasty should be performed in this group of patients
to improve fecundity is subject of debate.
It is questionable whether hysteroscopic metroplasty in women with recurrent
miscarriage and or subfertility will improve their reproductive outcome.
Study objective
This study will answer the question whether surgical intervention
(metroplasty) in women with recurrent miscarriage and/or subfertility and a
septate uterus will improve their reproductive outcome.
Study design
Randomized controlled trial.
Intervention
Random allocation to hysteroscopic metroplasty or no intervention.
Study burden and risks
We will compare expectant management with surgical intervention. The
intervention under research is a commonly practiced and safe operative
procedure in gynaecology, but it is not known whether it is efficacious.
The risk and burden of participation is the risk of known complications
following hysteroscopy.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
The trial will study women with a history of recurrent miscarriage or pregnancy loss before 20 weeks of gestational age and/or subfertility and a septate uterus. Recurrent miscarriage is defined as two or more, not necessarily consecutive, pregnancy losses before 20 weeks of gestational age. Subfertility is defined as the inability to conceive for a minimal period of one year. Only women with an active wish to conceive will be eligible.
Exclusion criteria
Prior inclusion in the TRUST study.
Contraindications for surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL24082.018.08 |
| OMON | NL-OMON27552 |