Obstetric and gynecologic experiences of women with Ehlers Danlos Syndrome

Principal Investigator: Dr. Colleen McDermott, Mount Sinai Hospital, University of Toronto
Co-Investigator: Dr. Olga Kciuk, University of Toronto

Introduction
You are being asked to take part in a research study. Please read this explanation about the study and its risks and benefits before you decide if you would like to take part. You should take as much time as you need to make your decision. Please ask the study doctor or study staff to explain anything that you do not understand and make sure that all of your questions have been answered before filling out this survey. Before you make your decision, feel free to talk about this study with anyone you wish. Participation in this study is voluntary.

Please only complete the survey one time.

Background and Purpose
You have been asked to participate in this study because you are involved in an Ehlers Danlos Syndrome patient organization, or because you have been in contact with a specialized Ehlers Danlos clinic. Despite the fact that many patients with Ehlers Danlos Syndrome are women, the medical literature includes few reports on obstetric and gynecologic conditions that may be linked with the disease. According to some reports, obstetric complications associated with EDS may include infertility, ectopic pregnancy, spontaneous abortions, preterm delivery, postpartum hemorrhage, and abnormal wound healing. Aortic dissection and uterine rupture in pregnancy have also been described in vascular-type EDS. From a gynecologic perspective, abnormal uterine bleeding, painful periods, pain with intercourse, incontinence, and pelvic organ prolapse have all been linked with EDS. No studies have addressed gynecologic symptom severity and impact on quality of life in women with EDS. The objective of this study is to survey 400 women who have been formally diagnosed with Ehlers Danlos Syndrome, in order to clarify the prevalence of obstetric and gynecologic conditions in this patient group and to understand the impact these conditions may have on quality of life.

Study Design
If you choose to participate, click “I agree” at the bottom of this page to start the survey. You will be asked about your medical history, including general medical and social information, past pregnancies, deliveries, diagnoses and surgeries. You will also be asked about your vaginal bleeding, pain, menopause symptoms, sexual function and bowel/bladder/pelvic floor symptoms. 

Risks/Inconveniences
There are no direct risks to participating in this study. It will take 25-40min to complete the survey, which needs to be done in one session. Some questions address sensitive topics such as sexual function. If you experience discomfort, you may withdraw from the study at any time by closing the survey window.

Benefits
There will be no direct benefit to you. Information learned from this study will help improve the medical understanding of obstetric and gynecologic conditions experienced by women with Ehlers Danlos Syndrome.

Confidentiality
Survey answers will be collected anonymously and stored under a participant number which will not be traceable to you. During the study period, answers will be stored securely on SimpleSurvey servers, which are based in Canada and abide by Canadian privacy laws. All information collected during this study, including your personal health information, will be collected anonymously and will not be shared with anyone outside the study unless required by law. The de-identified data will be transferred to Dr. McDermott’s Mount Sinai Hospital computer, which is password protected and located in her locked office. The original data will then be deleted from SimpleSurvey. It will be stored securely on the Mount Sinai Hospital computer for 7 years, then will be deleted. You will not be named in any reports, publications, or presentations that may come from this study.  If you decide to withdraw from the study, the information about you that was collected before you left the study may still be used. No new information will be collected without your permission.

Questions
If you have any questions about this study, please contact the Principal Investigator, Dr. Colleen McDermott (colleen.mcdermott@sinaihealthsystem.ca; tel. (416) 586-5133), or the Co-Investigator, Dr. Olga Kciuk (olga.kciuk@mail.utoronto.ca). If you have any questions about your rights as a research participant, or if you have concerns about this study, please contact Dr. Ronald Heslegrave, Chair of the Mount Sinai Hospital Research Ethics Board, at the Research Ethics Office: 416-586-4875.