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. 2017 Jan 17;2017(1):CD008576. doi: 10.1002/14651858.CD008576.pub4

ISRCTN28960271.

Trial name or title Pilot randomised controlled trial of hysteroscopic septal resection
Methods Randomised controlled trial
Participants Women with septate uteri and a history of miscarriage or preterm birth
Interventions Women will be randomised to septum resection or expectant management.
Outcomes Primary outcome: live birth surviving until discharge from hospital
Secondary outcome measures:

  1. Uterine perforation

  2. Fluid overload

  3. Endometritis

  4. Bleeding

  5. Incomplete resection

  6. Synechiae or adhesions

  7. Clinical pregnancy rate

  8. Miscarriage (first or second trimester)

  9. Premature delivery (< 34 weeks and < 37 weeks)

  10. Ectopic pregnancy

  11. Uterine rupture

  12. Delivery (vaginal, elective or emergency )

  13. Postpartum haemorrhage (1500 mL)

  14. Placenta praevia

  15. Morbidly adherent placenta
Starting date October 2013 (date of ethical approval)
Contact information Matthew Prior: mprior@me.com
Notes Pilot/feasibility RCT, so power calculation determined.
Currently 2 women have been included.
Protocol/serial number 13GY007