Other Clinical Trial - Monitoring Ovarian Cysts in Pregnancy

Status Not yet recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03440931
Study type	Observational
Source	Guy's and St Thomas' NHS Foundation Trust
Contact	Catherine Magee, MBChB
Phone	02071880864
Email	catherine.magee@gstt.nhs.uk
Status	Not yet recruiting
Phase	N/A
Start date	February 2018
Completion date	May 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02890914` - Transvaginal Ultrasound Training for Obstetrics and Gynecology Residents	N/A
Completed	`NCT01779232` - Danazol Treatment in Endometriosis Women Before IVF	Phase 4
Completed	`NCT05054946` - The Effect of Laparoscopic Surgery on Ovarian Reserve According to Cyst Types	N/A
Completed	`NCT02852447` - The Effect of Surgery for Non Endometriosic Ovarian Cysts on Ovarian Reserve	N/A
Completed	`NCT00713778` - The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst	Phase 4
Suspended	`NCT00865488` - Evaluation of Adhexil Safety and Efficacy in Prevention and/or Reduction of Adhesions in Gynecological Surgery	Phase 3
Completed	`NCT04142203` - Implementation of 23 Hour Surgery Model in a Tertiary Hospital
Recruiting	`NCT05842629` - Improved Diagnosis of Ovarian Cancer
Completed	`NCT05376384` - Ovarian Cyst's Enucleation Spillage Score
Recruiting	`NCT04993924` - GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian Cyst	Phase 4
Terminated	`NCT03189316` - Anti-inflammatory Cells in Peritoneal Cavity	N/A
Completed	`NCT05800613` - Management of Ovarian Masses in Pediatric Patients: an Italian Survey
Completed	`NCT04355312` - Using INDOcyanine Green to Analyse Ovarian Vascularization After Ovarian Laparoscopic CYStectomy	N/A
Completed	`NCT05418595` - Ultrasonographic Evaluation of Ovarian Stromal Vascularity in Women With Polycystic Ovary Syndrome (PCOS)
Completed	`NCT06342934` - Radiomics and Machine Learning in the Diagnosis of Ovarian Masses
Completed	`NCT06227676` - Effect of 'Cramp Bites' on Period Cramps in Women Aged 18-25	Phase 2/Phase 3
Recruiting	`NCT02831556` - Point of Care 3D Ultrasound for Various Applications: A Pilot Study
Recruiting	`NCT05763511` - Improved Diagnosis of Ovarian Cancer by Use of Circulating Tumor DNA as a Biomarker
Completed	`NCT06064331` - Effect of Intravenous Lignocaine Infusion on Intraoperative End Tidal Desflurane Concentration Requirements	N/A
Recruiting	`NCT02086318` - A New Algorithm to Predict Ovarian Age	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.