Monitoring Ovarian Cysts in Pregnancy

NCT03440931 | Unknown

• 1 other identifier: 239020
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Cysts

Outcome Measures

Primary Outcomes (1)

• The proportion of ovarian cysts that are still visible at the final scan (6 weeks post partum)

  10 months

Secondary Outcomes (5)

• 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

Interventions

Ultrasound scan DIAGNOSTIC_TEST

Transvaginal ultrasound scan to assess ovaries

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• \- 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

MeSH Terms

Conditions

Ovarian Cysts

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Catherine Magee, MBChB

  Guys and St. Thomas' NHS Foundatiuon Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Magee, MBChB

CONTACT

02071880864; catherine.magee@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 22, 2018
• Study Start: February 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 1, 2018

Record last verified: 2018-02