Monitoring Ovarian Cysts in Pregnancy

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.

Study Overview

• Status: Unknown
• Conditions: Ovarian Cysts
• Intervention / Treatment: Diagnostic test: Ultrasound scan

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Catherine Magee, MBChB; Phone Number: 02071880864; Email: catherine.magee@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women (diagnosed on urinary HCG) who attend the Early Pregnancy Unit at St. Thomas' Hospital and undergo an early pregnancy ultrasound scan. If the scan also shows one or more ovarian cysts, they are eligible for the study, as per the criteria above.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of ovarian cysts that are still visible at the final scan (6 weeks post partum)	10 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The nature of the ovarian cysts (i.e functional/dermoid/endometrioma/borderline/malignant)	10 months
The proportion of patients who required other imaging as well as ultrasound scans (eg. MRI)	10 months
The prevalence of ovarian cysts in pregnancy	16 months
The proportion of pregnant women who still have a corpus luteum at 20 weeks	5 months
The proportion of pregnant woman with ovarian cysts who require surgical intervention	10 months

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Catherine Magee, MBChB, Guys and St. Thomas' NHS Foundatiuon Trust

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): May 1, 2019

Study Registration Dates

• First Submitted: January 12, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (ACTUAL): February 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 1, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pathological Conditions, Anatomical; Ovarian Cysts; Cysts
• Other Study ID Numbers: 239020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No