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Spots Global Cancer Trial Database for Monitoring Ovarian Cysts in Pregnancy

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Trial Identification

Brief Title: Monitoring Ovarian Cysts in Pregnancy

Official Title: Monitoring Ovarian Cysts in Pregnancy

Study ID: NCT03440931

Conditions

Ovarian Cysts

Interventions

Ultrasound scan

Study Description

Brief Summary: This prospective study will primarily aim to determine what monitoring is required of ovarian cysts when they are diagnosed in pregnancy, as well as what intervention, if any, is necessary. It also aims to identify the prevalence of ovarian cysts in pregnancy and the nature of these cysts, as well as their natural history throughout pregnancy.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 16 Years

Eligible Ages: CHILD, ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

Contact Details

Name: Catherine Magee, MBChB

Affiliation: Guys and St. Thomas' NHS Foundatiuon Trust

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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