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
IRAS No: 213740
A cohort study in couples who have suffered miscarriage with assessment of future pregnancy outcome
The aim of this study to undertake a large cohort study of pregnancy outcome following miscarriage.
Not provided at time of registration
Observational cohort study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
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 six 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.
Primary outcome measure
Live birth rate is assessed by patient questionnaire and data linkage at six monthly intervals until family is complete and child is age 5.
Secondary outcome measures
1. Miscarriage rate is assessed by patient questionnaire and data linkage at six monthly intervals until family is complete
2. Type of miscarriage is assessed by patient questionnaire and data linkage at six monthly intervals until family is complete
3. Obstetric complications are assessed by patient questionnaire and data linkage at six monthly intervals until family is complete
4. Neonatal complications are assessed by patient questionnaire and data linkage at six monthly intervals until family is complete
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Couples with a history of one or more pregnancy losses
2. Aged between 18-55
Target number of participants
Participant exclusion criteria
Couples who decline to give consent.
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Trial participating centre
Birmingham Women's Hospital Foundation Trust
Mindelsohn Way Edgbaston
Trial participating centre
Imperial College Healthcare NHS Trust
Hammersmith Hospital Campus Du Cane Road
Tommy's Baby Charity
Funding Body Type
private sector organisation
Funding Body Subtype
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
Participant level data
Stored in repository
Basic results (scientific)