Ovarian hyperstimulation syndrome Pregnancy and Childbirth
Conditions
Interventions
Design:
A randomised controlled trial (RCT) to assess the clinical and cost-effectiveness, safety profile and acceptability of outpatient paracentesis compared to conventional conservative management
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women presenting with moderate or severe, early or late OHSS as defined by the trial (see trial protocol for full definitions) 2. Patients able and willing to attend weekly follow-up appointments in person or remotely, daily remote appointments/phone calls, and able to undertake self-monitoring at home
Exclusion criteria
Exclusion criteria: 1. OHSS-related exclusion criteria: 1.1. Significant pain* or vomiting requiring hospitalisation 1.2. Pulmonary embolism 1.3. When in the judgment of the clinician, the patient’s condition is severe enough to warrant admission to a High Dependency Care Unit (such as Critical OHSS as defined in the Royal College of Obstetricians and Gynaecologists (RCOG) green-top guidelines) and therefore not suitable for outpatient management 2. Non-OHSS related medical conditions: a concurrent medical condition requiring immediate inpatient management 3. Patients who have been previously randomised but later present with moderate or severe OHSS symptoms in subsequent cycles after their initial trial involvement 4. Participation in other trials involving ovarian stimulation or ovarian response *Significant pain will require clinical judgement but may be guided by whether the patient is able to cope at home using ’over the counter’ analgesia or if there are any clinical concerns regarding other conditions potentially contributing to the pain (e.g. ectopic pregnancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OHSS-related hospitalisation for at least 24 hours measured using data collected by staff at fertility units by contacting the participant by telephone during monitoring, at patient visits within 28 days of randomisation or collected from hospital notes after 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of was changed from ISRCTN71978064 . 1. Need for hospitalisation (OHSS related) measured using data collected during symptom deterioration visits or other routes of hospitalisation, including clinical data and reasons stated for hospitalisation within 28 days of randomisation – independent blinded central assessment 2. Cumulative length of OHSS related hospitalisation - providing a measure of the total burden of hospital stay assessed within 28 days post-randomisation, including any admissions for short periods that may not have met the primary outcome. 3. Time to resolution of OHSS measured using normalisation of the haematocrit and haemoglobin concentrations, normalisation of fluid input and output (no longer in a positive fluid balance), decrease in weight, and decrease in abdominal girth within 28 days of randomisation 4. Progression of OHSS severity measured using the following criteria: 4.1. Progression criteria from moderate to severe indicated by fluid accumulation in abdomen which becomes clinical ascites/clinically detectable with or with hydrothorax, with any of the following additional symptoms: 4.1.1. Clinical ascites (± hydrothorax) 4.1.2. Oliguria (0.45 4.1.4. Hyponatraemia (sodium 5 mmol/l) 4.1.7. Hypoproteinaemia (serum albumin 12 cm 4.2. Progression criteria from severe to critical indicated by evidence of any one of the following features: 4.2.1. Participant has a large hydrothorax 4.2.2. Increasing haematocrit levels to >0.55 4.2.3. A white cell count of over 25000/ml (confirmed via FBC test) 4.2.4. Change from oliguria (low urine output) to anuria (very little/no urine) (0.45 3.1.4. Hyponatraemia (sodium 5 mmol/l) 3.1.7. Hypoproteinaemia (serum albumin 12 cm 3.2. Progression criteria from severe to critical indicated by evidence of any one of the following features: 3.2.1. Participant has a large hydrothorax 3.2.2. Increasing haematocrit levels to >0.55 3.2.3. A white cell count of over 25000/ml (confirme | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactKatie Ridsdale
Outcome results
None listed