Monitoring Ovarian Cysts in Pregnancy
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|ClinicalTrials.gov Identifier: NCT03440931|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2018
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment|
|Ovarian Cysts||Diagnostic Test: Ultrasound scan|
The Royal College of Obstetricians and Gynaecologists currently publish guidelines for the management of ovarian cysts in both pre and post-menopausal women. The guidelines for pre-menopausal women do not specifically include pregnant women, and it is known from previous research that the characteristics of ovarian cysts can differ in pregnancy, and therefore appear different on ultrasound scan. Also, where intervention is needed, it is usually surgical which can have high risk implications in pregnancy.
The study will be conducted in the Early Pregnancy and Acute Gynaecology Unit at St. Thomas' Hospital. Any woman who presents with symptoms in early pregnancy (less than 18 weeks) is offered a transvaginal ultrasound scan. If, on this scan, they are found to have an ovarian cyst, they will be considered for the study. Once the ovarian cyst has initially been diagnosed, a confirmatory scan will be carried out by one of the investigators (ie. a clinical fellow, consultant gynaecologist or senior sonographer).
If the cyst is benign in nature and not the cause of acute symptoms, three more transvaginal scans will be carried out by one of the investigators at approximately 12 weeks and 20 weeks (in line with the nuchal translucency scan and anomaly scan), then at 6 weeks post partum. It is intended that all these patients will be managed without surgical intervention.
If there are concerns that the cyst is malignant, the participant would be investigated via the already established pathways. If the participant is at any point in acute pain and the cyst is thought to be the cause of this eg. ovarian torsion or cyst rupture, then a clinical decision would be made regarding surgical intervention.
The total study period will be up to 16 months. This includes a 6 month recruitment period, then following up each participant until 6 weeks post delivery.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Monitoring Ovarian Cysts in Pregnancy|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
- Diagnostic Test: Ultrasound scan
Transvaginal ultrasound scan to assess ovaries
- The proportion of ovarian cysts that are still visible at the final scan (6 weeks post partum) [ Time Frame: 10 months ]
- The nature of the ovarian cysts (i.e functional/dermoid/endometrioma/borderline/malignant) [ Time Frame: 10 months ]
- The proportion of patients who required other imaging as well as ultrasound scans (eg. MRI) [ Time Frame: 10 months ]
- The prevalence of ovarian cysts in pregnancy [ Time Frame: 16 months ]
- The proportion of pregnant women who still have a corpus luteum at 20 weeks [ Time Frame: 5 months ]
- The proportion of pregnant woman with ovarian cysts who require surgical intervention [ Time Frame: 10 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440931
|Contact: Catherine Magee, MBChBemail@example.com|
|Principal Investigator:||Catherine Magee, MBChB||Guys and St. Thomas' NHS Foundatiuon Trust|