Monitoring Ovarian cysts in Pregnancy
Research type
Research Study
Full title
Monitoring Ovarian Cysts in Pregnancy.
IRAS ID
239020
Contact name
Jonathan Gaughran
Contact email
Sponsor organisation
Guys & St. Thomas' NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 30 days
Research 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. Currently, there are guidelines on the management of ovarian cysts in pre or post-menopausal women, but none of these apply specifically to 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 (under 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 myself, a consultant gynaecologist or a 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 myself or a senior sonographer at approximately 12 weeks and 20 weeks (in line with the nuchal translucency scan and anomaly scan), then at 6 weeks post partum.
If there are concerns that the cyst is malignant, the participant would be investigated via 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 will be made regarding surgical intervention.
The total study period will be up to 19 months. This includes a 9 month recruitment period, then following up each participant until 6 weeks post delivery.
REC name
London - Dulwich Research Ethics Committee
REC reference
18/LO/1033
Date of REC Opinion
9 Aug 2018
REC opinion
Further Information Favourable Opinion