Ovarian CystsNCT03440931
Monitoring Ovarian Cysts in Pregnancy
An observational study of Ovarian Cysts, run by Guy's and St Thomas' NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cysts
- What is being tested?
- Ultrasound scan
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Ovarian Cysts
- Being tested
- Ultrasound scan
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound scanDiagnostic test
Transvaginal ultrasound scan to assess ovaries
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of ovarian cysts that are still visible at the final scan (6 weeks post partum)
Measured: 10 months
Secondary outcomes (5)
The nature of the ovarian cysts (i.e functional/dermoid/endometrioma/borderline/malignant)
Measured: 10 months
The proportion of patients who required other imaging as well as ultrasound scans (eg. MRI)
Measured: 10 months
The prevalence of ovarian cysts in pregnancy
Measured: 16 months
The proportion of pregnant women who still have a corpus luteum at 20 weeks
Measured: 5 months
The proportion of pregnant woman with ovarian cysts who require surgical intervention
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CystsStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Magee, MBChB, Principal investigator, Guys and St. Thomas' NHS Foundatiuon Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440931
- Sponsor's protocol ID
- 239020
- Status last verified
- Feb 2018
- First submitted
- 12 Jan 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Ovarian Cysts in Pregnancy
- ClinicalTrials.gov ID
- NCT03440931
- Acronym / sponsor ID
- 239020
- Conditions
- Ovarian Cysts
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Feb 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound scanTransvaginal ultrasound scan to assess ovaries | Diagnostic test | – |
Primary outcome
The proportion of ovarian cysts that are still visible at the final scan (6 weeks post partum)
Time frame: 10 months
5 secondary outcomes
The nature of the ovarian cysts (i.e functional/dermoid/endometrioma/borderline/malignant)
Time frame: 10 months
The proportion of patients who required other imaging as well as ultrasound scans (eg. MRI)
Time frame: 10 months
The prevalence of ovarian cysts in pregnancy
Time frame: 16 months
The proportion of pregnant women who still have a corpus luteum at 20 weeks
Time frame: 5 months
The proportion of pregnant woman with ovarian cysts who require surgical intervention
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Magee, MBChB principal investigator
Guys and St. Thomas' NHS Foundatiuon Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cysts, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Magee, MBChB (02071880864, catherine.magee@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of ovarian cysts that are still visible at the final scan (6 weeks post partum) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.