Plain English Summary
Background and study aims
Women might miscarry or give birth prematurely because their wombs are divided by a wall (uterine septum). The aim in this study is to answer whether surgery to remove the wall in the womb is beneficial for women who have had miscarriages or premature babies.
Who can participate?
Women with a uterine septum, a history of miscarriage or preterm birth, or infertility.
What does the study involve?
Patients will be allocated to surgery (hysteroscopic septal resection) or no surgery. The wall in the womb can be removed or divided to make the womb normal. The surgery uses a telescope (hysteroscopy) to remove the wall.
What are the possible benefits and risks of participating?
There is some evidence to suggest that keyhole septal resection might be beneficial for women with a uterine septum and a history of miscarriage. The risk of surgery includes bleeding, infection and perforation of the womb. The complication rate for this type of procedure is about 1%.
Where is the study run from?
Nottingham University Hospitals NHS Trust (UK)
When is the study starting and how long is it expected to run for?
December 2014 to December 2017
Who is funding the study?
Nottingham University Hospitals Charity (UK)
Who is the main contact?
Dr Matthew Prior
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
13GY007
Study information
Scientific title
Assessment of hysteroscopic metroplasty in women with a uterine septum and a history of miscarriage: a randomised controlled trial
Acronym
SEPTUM
Study hypothesis
Hysteroscopic septal resection in women with septate uteri and a history of miscarriage increases the proportion of women who have live births.
On 06/08/2015 the study design was changed from 'Pilot single-centre randomised controlled trial to assess feasibility for a larger adequately powered trial' to 'Pilot multi-centre randomised controlled trial to assess feasibility for a larger adequately powered trial'
Ethics approval
National Research Ethics Service Committee East Midlands - Nottingham 1, 22/10/2013, 13/EM/0362
Study design
Pilot multi-centre randomised controlled trial to assess feasibility for a larger adequately powered trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Women with septate uteri, a history of miscarriage or preterm birth, or infertility
Intervention
1. Hysteroscopic septal resection
2. No intervention
All patients will be followed up in the same way.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
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. Post-partum haemorrhage (1500 mL)
14. Placenta praevia
15. Morbidly adherent placenta
Overall trial start date
09/12/2014
Overall trial end date
31/12/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Uterine septum diagnosed with three-dimensional ultrasound
2. Aged at least 18 years old
3. Desire to conceive
4. History of one or more miscarriages (regardless of previous viable or live births
5. No previous surgery on the uterus or endometrial cavity
6. Body-mass index of 40 kg/m² or less
Added 06/08/2015:
7. Women with infertility
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
10
Participant exclusion criteria
1. Other uterine anomalies apart from septum
2. Age younger than 18 years old
3. Not planning to become pregnant
4. Currently pregnant
Recruitment start date
09/12/2015
Recruitment end date
31/12/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nottingham University Hospitals NHS Trust (UK)
-
United Kingdom
Sponsor information
Organisation
Nottingham University Hospitals NHS Trust
Sponsor details
Research & Innovation Nottingham University Hospitals NHS Trust Nottingham Integrated Clinical Research Centre
C Floor
South Block Queen’s Medical Centre Campus
Nottingham
NG7 2UH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Nottingham University Hospitals Charity (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary