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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03440931
Other study ID # 239020
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 12, 2018
Last updated February 28, 2018
Start date February 2018
Est. completion date May 2019

Study information

Verified date February 2018
Source Guy's and St Thomas' NHS Foundation Trust
Contact Catherine Magee, MBChB
Phone 02071880864
Email catherine.magee@gstt.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date May 2019
Est. primary completion date May 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 16 Years to 50 Years
Eligibility Inclusion Criteria:

- Age 16-50 Pregnant Scanned in the Early Pregnancy Unit at St. Thomas' Hospital (either as a walk in patient / a ward in-patient / referred from A&E or another speciality) At least one ovarian cyst (excluding a corpus luteum)

Exclusion Criteria:

- Age <16 (so as to avoid problems with consent / Gillick competence) Not pregnant (ie. attending the unit with acute gynaecology problem or for follow up after a miscarriage) Lacks capacity to consent Corpus luteal cyst only on ultrasound scan

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ultrasound scan
Transvaginal ultrasound scan to assess ovaries

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of ovarian cysts that are still visible at the final scan (6 weeks post partum) 10 months
Secondary The nature of the ovarian cysts (i.e functional/dermoid/endometrioma/borderline/malignant) 10 months
Secondary The proportion of patients who required other imaging as well as ultrasound scans (eg. MRI) 10 months
Secondary The prevalence of ovarian cysts in pregnancy 16 months
Secondary The proportion of pregnant women who still have a corpus luteum at 20 weeks 5 months
Secondary The proportion of pregnant woman with ovarian cysts who require surgical intervention 10 months
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