Septum resection versus expectant management in women with a septate uterus: an international multicentre open-label randomized controlled trial
An international multicentre randomized controlled trial was carried out to compare reproductive outcomes in women with a septate uterus following hysteroscopic septum resection or expectant (standard) management.
Women featuring a septate uterus and history of subfertility, pregnancy loss or preterm birth, trying to conceive were recruited, from 3 tertiary-care hospitals and 4 secondary-care hospitals, across the Netherlands, USA, UK and Iran. Women with a contraindication to surgery were automatically excluded from the study.
In total 80 women between October 2010 and September 2018 were recruited and randomly assigned to either septum resection or expectant management.
Hysteroscopic septum resection was performed under general or loco-regional anaesthesia with laparoscopic or ultrasound monitoring to monitor depth of resection and prevent uterine perforation. Follow-up of septum resection was carried out 6-8 weeks post-operation via diagnostic hysteroscopy.
In the expectant management group women were advised to continue trying to conceive naturally or with the help of assisted reproductive technology for those classified subfertile. Women with recurrent pregnancy loss and co-existing antiphospholipid syndrome were allowed low dose aspirin or low molecular weight heparin.
For this study subfertility was defined as the inability to conceive for a minimum of 12 months. Pregnancy loss was defined as the spontaneous demise of a pregnancy before 24 weeks gestation. Clinical pregnancy, the presence of a foetal heartbeat at or after 6 weeks pregnancy, while ongoing pregnancy was defined as a viable pregnancy of at least 12 weeks in duration.
Primary outcome of the study was conception leading live birth within 12 months, with live birth defined as the birth of a living foetus after 24 weeks gestation. Women were followed for at least 1 year, and for the duration of pregnancy among those that conceived within the trial period.
Of the 80 women in total, 69 successfully completed the trial. No serious / adverse events were recorded among the septum resection group. Baseline characteristics: age, parity, BMI, smoker status, pregnancy loss, subfertility, preterm birth, partial or complete septum, was similar between the 2 groups.
Intention-to-treat analysis found that 31% of women (12/39) allocated to septum resection had a live birth, compared to 35% or women (14/40) in the expected management group. No significant difference in clinical pregnancy, ongoing pregnancy, pregnancy loss or preterm birth rates was found.
Interestingly pregnancy loss was moderately higher among the septum resection group (28 vs 13%) although this was not statistically significant (deemed valid) when study size was taken into account.
Further analysis showed mean time of conception leading to live birth was 9.8 months for septum resection and 9.2 months for expectant management.
At the time of delivery, breech presentation occurred in 2 women allocated to septum resection, and 6 women allocated to expected management. Twin pregnancies occurred in 2 women among the septum resection group and none in expected management. No cases of ectopic pregnancy, uterine rupture, placental abruption, postpartum haemorrhage or intra-uterine foetal death was reported.
Per-protocol analysis of primary and secondary outcomes returned very similar results to intention-to-treat analysis with only a moderate but statistically insignificant difference in pregnancy loss (28 vs 15%) comparing septum resection to expectant management.
Finally among the 7 women featuring a complete septate uterus, live birth occurred in 2 of the 3 (66.7%) women who underwent septum resection, whilst 3 of the other 4 (75%) women who undertook expected management also had a live birth.
SUMMARY: SEPTATE UTERUS AND INFERTILITY
Resection of a septate uterus failed to increase the rate of clinical pregnancy, ongoing pregnancy and live births (31 vs. 35 %), compared to similar women under expectant (non-surgical) management, although pregnancy loss was higher (28 vs. 13 %) but not statistically significant for septum resection.
- Small study size
Rikken J F W, et al. (2020). Corrigendum. Septum resection in women with a septate uterus: a cohort study. https://doi.org/10.1093/humrep/deaa141
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