Condition category
Pregnancy and Childbirth
Date applied
06/01/2015
Date assigned
27/01/2015
Last edited
06/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Dr Matthew Prior

ORCID ID

Contact details

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

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

Publication citations

Additional files

Editorial Notes