Condition category
Pregnancy and Childbirth
Date applied
28/02/2017
Date assigned
14/03/2017
Last edited
22/09/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current plain English summary as of 18/09/2020:
Background and study aims
Miscarriage is a term given to the loss of a baby during the first 23 weeks of pregnancy. Some women experience recurrent miscarriage, in which they experience three or more miscarriages in a row. Recurrent miscarriage is a distressing problem for which there is no effective preventative treatment currently. In order to develop new treatments, we need to identify couples at high risk of future pregnancy loss. There is little evidence that assesses the predictive power of current tests and risk factors, such as pregnancy loss history and body mass index (BMI). There have been very few long-term follow-up studies with accurate recording of future pregnancy outcomes. This study is using digital technology to collect and analyse information about the patient’s history and investigation results and link these to pregnancy and neonatal outcome. The aim of this study is to undertake a large study of pregnancy outcome following miscarriage.

Who can participate?
Couples who have suffered miscarriage.

What does the study involve?
After agreeing to take part, women and their partners are asked to complete a questionnaire about their previous experiences with pregnancy loss and have their medical records reviewed to find out about their medical history. Every 6 months, couples are asked to fill in questionnaires about whether they have had any reproductive treatment and if that has led to a successful pregnancy and birth. Information collected in this study is then used to identify couples at risk of pregnancy loss and to predict pregnancy outcomes.
Participants will also be offered the opportunity to give their consent to take part in future Cohort Multiple Randomised Controlled Trials (cmRCT). Participants will agree to participate in the control (no treatment) arm of any future trials that will be conducted by the research team. If the participant is allocated to the intervention group of a future trial, they will be asked to provide their consent prior to taking the intervention.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
1. University Hospitals Coventry and Warwickshire NHS Trust (UK)
2. Birmingham Women's Hospital Foundation Trust (UK)
3. Imperial College Healthcare NHS Trust (UK)

When is the study starting and how long is it expected to run for?
April 2016 to April 2026

Who is funding the study?
Tommy’s Baby Charity (UK)

Who is the main contact?
Professor Siobhan Quenby
s.quenby@warwick.ac.uk
_____

Previous plain English summary:
Background and study aims
Miscarriage is a term given to the loss of a baby during the first 23 weeks of pregnancy. Some women experience recurrent miscarriage, in which they experience three or more miscarriages in a row. Recurrent miscarriage is a debilitating disorder for which there is no effective medical intervention. In order to develop new interventions, we need to identify couples at high risk of future pregnancy loss. There is little published data that assesses the prognostic use of current tests and risk factors such as pregnancy loss history and BMI. There have been very few long-term follow-up studies with accurate recording of future pregnancy outcomes. This study is using digital technology to collect and analyse information about the patient’s history, investigation results and link these to pregnancy and neonatal outcome. The aim of this study is to undertake a large cohort study of pregnancy outcome following miscarriage.

Who can participate?
Couples who have suffered miscarriage.

What does the study involve?
After agreeing to take part, women and their partners are asked to complete a questionnaire about their previous experiences with pregnancy loss and have their medical records reviewed to find out about their medical history. Every six months, couples are asked to fill in questionnaires about whether they have had any reproductive treatment and if that has led to a successful pregnancy and birth. Information collected in this study is then used to identify couples at risk of pregnancy loss and to predict pregnancy outcomes.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.

Where is the study run from?
1. University Hospitals Coventry and Warwickshire NHS Trust (UK)
2. Birmingham Women's Hospital Foundation Trust (UK)
3. Imperial College Healthcare NHS Trust (UK)

When is the study starting and how long is it expected to run for?
April 2016 to April 2026

Who is funding the study?
Tommy’s Baby Charity (UK)

Who is the main contact?
Professor Siobhan Quenby
s.quenby@warwick.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Prof Siobhan Quenby

ORCID ID

http://orcid.org/0000-0003-3221-5471

Contact details

Clinical Sciences Research Laboratories
University Hospitals Coventry and Warwickshire NHS Trust
Coventry
CV2 2DR
United Kingdom
+44 2476 968592
s.quenby@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS 213740

Study information

Scientific title

A cohort study in couples who have suffered miscarriage with assessment of future pregnancy outcome

Acronym

Tommy's Net

Study hypothesis

Some women experience recurrent miscarriage, in which they experience three or more miscarriages in a row. Recurrent miscarriage is a debilitating disorder for which there is no effective medical intervention. In order to develop new interventions, we need to identify couples at high risk of future pregnancy loss. There is little published data that assesses the prognostic use of current tests and risk factors such as pregnancy loss history and BMI. There have been very few long-term follow-up studies with accurate recording of future pregnancy outcomes. This study is using digital technology to collect and analyse information about the patient’s history, investigation results and link these to pregnancy and neonatal outcome. The aim of this study to undertake a large cohort study of pregnancy outcome following miscarriage.

Ethics approval

1. Approved 09/03/2017, West Midlands Research Ethics Committee (Health Research Authority, Ground Floor, Skipton House, 80 London Road, London SE1 6LH; +44 (0)207 104 8193; NRESCommittee.WestMidlands-Edgbaston@nhs.net), ref: 17/WM/0050
2. Amended 11/05/2020, West Midlands Research Ethics Committee (Health Research Authority, Ground Floor, Skipton House, 80 London Road, London SE1 6LH; +44 (0)207 104 8193; edgbaston.rec@hra.nhs.uk), ref: 17/WM/0050, amendment reference AM04

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Miscarriage

Intervention

Couples will be asked to fill in clinical history sheets prior to clinic visits. When they arrive at the clinic a member of the research team will explain Tommy’s Net and ask them to consent to the study. If they consent they will be asked permission to have their data entered into a bespoke server and database. This system will then also import results of investigations and reproductive outcomes. Couples will be contacted every 6 months for details of further reproductive treatment and pregnancy outcomes. The baby’s NHS number will be requested through appropriate consent so that follow up of the baby’s development could be facilitated. Information regarding the babies developmental follow up will be requested from GP records using data linkage.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Live birth rate is assessed by patient questionnaire and data linkage at 6-month intervals until family is complete and child is aged 5 years.

Secondary outcome measures

1. Miscarriage rate is assessed by patient questionnaire and data linkage at 6-month intervals until family is complete
2. Type of miscarriage is assessed by patient questionnaire and data linkage at 6-month intervals until family is complete
3. Obstetric complications are assessed by patient questionnaire and data linkage at 6-month intervals until family is complete
4. Neonatal complications are assessed by patient questionnaire and data linkage at 6-month intervals until family is complete

Overall trial start date

01/04/2016

Overall trial end date

01/04/2026

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Couples with a history of one or more pregnancy losses
2. Aged between 18-55

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

9000

Participant exclusion criteria

Couples who decline to give consent.

Recruitment start date

01/04/2017

Recruitment end date

01/04/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

Birmingham Women's Hospital Foundation Trust
Mindelsohn Way Edgbaston
Birmingham
B15 2TG
United Kingdom

Trial participating centre

Imperial College Healthcare NHS Trust
Hammersmith Hospital Campus Du Cane Road
London
W12 0NN
United Kingdom

Sponsor information

Organisation

University Hospitals Coventry and Warwickshire NHS trust

Sponsor details

Clinical Sciences Research Laboratories
Coventry
CV2 2DR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Tommy's Baby Charity

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publications will occur at annual intervals in high-impact peer reviewed journals.

IPD Sharing plan:
The participant level data will be stored on on the secure, NHS, N3 encrypted system in a server in UHCW access to this will be controlled to met with information governance standards as laid down in the Information Goverance Tool Kit.

Intention to publish date

01/04/2027

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/09/2020: The ethics approval information has been added. 18/09/2020: The plain English summary has been updated. 22/09/2017: Internal review. 18/07/2017: Internal review