Pilot randomised, controlled trial of hysteroscopic septal resection
Research type
Research Study
Full title
Randomised, controlled study of hysteroscopic metroplasty for women with a septate uterus and a history of miscarriage or preterm labour.
IRAS ID
131663
Contact name
Nicholas Raine-Fenning
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Research summary
Background: It is thought that miscarriages and preterm deliveries are more common in women with a particular type of abnormally shaped womb called a septate uterus. The septum is a piece of muscle, which divides the womb cavity into two separate compartments. The septum can be removed or divided in an attempt to make the womb appears normal again. This surgery, which is known as “hysteroscopic septal resection” uses a telescope (hysteroscopy) to remove septums. It is performed regularly but we do not know if it is beneficial or safe.
Aims: We plan to investigate if hysteroscopic removal of the uterine septums improves pregnancy outcomes in a subsequent pregnancy in women with a history of miscarriage or preterm delivery.
Methods: 10 high-risk women who are known to have septate uterus will be randomised either to the treatment group or control group. Women in treatment group will have hysteroscopic surgery to remove the septum while the control group will have diagnostic hysteroscopy but the septum will not be removed. These women will be followed up until the end of the first clinical pregnancy or for approximately 24 months from treatment if not pregnant.
Outcomes: The proportions of women with miscarriages will be determined. Live birth beyond 28 weeks, 32 weeks and 37 weeks gestation; and any surgical complications will be recorded as secondary outcomes.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
13/EM/0362
Date of REC Opinion
22 Oct 2013
REC opinion
Favourable Opinion