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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Megumi
Nimura
megumi.nimura@nhs.net
Tom
Bourne
womensultrasound@btinternet.com
Dr
Christopher
Kyriacou
Christopher.kyriacou@nhs.net
Margaret
Pikovsky
m.pikovsky@nhs.net
Pregnancy with abortive outcome
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Purpose and design - There is a need for the patient care pathway to evolve in order to aid and improve the diagnosis and management of women with a PUL and EP. There is potential for this to be achieved by the incorporation of a statistical model that uses one or more novel markers identified by this study. These markers may replace or add to the effectiveness of markers used in the current statistical model.
Recruitment – 200 patients. Inclusion criteria: Patients attending the Early Pregnancy Unit (EPU) in the first trimester with a PUL or ectopic pregnancy on trans-vaginal ultrasound scan between the ages of 18-50 years. Exclusion criteria: Presence of an acute medical condition, patients aged less than 18 years, patients who cannot give fully informed study consent.
Consent - Posters will advertise the study. Patients in EPU will be invited to the study by a member of the clinical care team. Written consent will be required for all aspects of the study other than for 3-dimensional scanning of PUL and EP patients, where verbal consent will be obtained. Patients will be given at least 24 hours to consider whether they wish to participate.
Confidentiality - The Chief Investigator will preserve the confidentiality of participants taking part in the study and is registered under the Data Protection Act. Patient consent forms will be stored securely within the study file. All patient identifiable information, where required, will be stored electronically on NHS approved computers, accessible only by personnel involved in the study via password.
Conflict of interest – None involved in the study have a conflict of interest.
Dissemination of results – No patient identifiable information will be included in the PhD research report or publication. Anonymised results will be disseminated to scientific community by means of publication in peer-reviewed literature and presented at national and international meetings.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cohort study;
You can take part if:
You may not be able to take part if:
Presence of an acute medical condition, patients aged less than 18 years, patients who cannot give fully informed study consent (language or learning impairment), presence of a viable intrauterine pregnancy and presence of miscarriage. Exclusion to fallopian tube samples - presence of any ectopic pregnancy that does not require operative salpingectomy. Exclusion to peritoneal washings - presence of any ectopic pregnancy that does not require access to the peritoneal cavity as part of management. Exclusion to trophoblast tissue sampling - presence of an ectopic pregnancy that does not require surgical removal.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Margaret
Pikovsky
m.pikovsky@nhs.net
Dr
Christopher
Kyriacou
Christopher.kyriacou@nhs.net
Megumi
Nimura
megumi.nimura@nhs.net
Tom
Bourne
womensultrasound@btinternet.com
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by NIHR Imperial Biomedical Research Centre; SAMSUNG ELECTRONICS LIMITED; GENESIS RESEARCH TRUST; TOMMY'S; .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 42744
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
