Pilot randomised controlled trial of hysteroscopic septal resection

ISRCTN	ISRCTN28960271
DOI	https://doi.org/10.1186/ISRCTN28960271
Secondary identifying numbers	13GY007

Submission date: 06/01/2015
Registration date: 27/01/2015
Last edited: 06/08/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Matthew Prior
Public

Nurture Fertility
B Floor
East Block
Nottingham University Hospitals NHS Trust
Queen's Medical Centre Campus
Derby Road
Nottingham
NG7 2UH
United Kingdom

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Assessment of hysteroscopic metroplasty in women with a uterine septum and a history of miscarriage: a randomised controlled trial
Study acronym	SEPTUM
Study objectives	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(s)	National Research Ethics Service Committee East Midlands - Nottingham 1, 22/10/2013, 13/EM/0362
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	09/12/2014
Completion date	31/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	10
Key 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
Key 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
Date of first enrolment	09/12/2015
Date of final enrolment	31/12/2017

Locations

Countries of recruitment

United Kingdom

Study participating centre

Nottingham University Hospitals NHS Trust (UK)

-
United Kingdom

Sponsor information

Nottingham University Hospitals NHS Trust
Hospital/treatment centre

Research & Innovation Nottingham University Hospitals NHS Trust Nottingham Integrated Clinical Research Centre
C Floor
South Block Queen’s Medical Centre Campus
Nottingham
NG7 2UH
England
United Kingdom

"ROR"	https://ror.org/05y3qh794

Funders

Funder type

Charity

Nottingham University Hospitals Charity (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No