Pregnancy with abortive outcome Pregnancy and Childbirth
Conditions
Interventions
The trial will compare surgical evacuation of products of conception with intraoperative ultrasonography versus surgical evacuation without intraoperative ultrasonography. This is a feasibility study
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 16 years or over. 2. Referred for surgical evacuation of products of conception. 3. Willingness to be randomised between treatment modalities. 4. Willingness to undergo office hysteroscopy 4-8 weeks following surgical management of miscarriage. 5. Written informed consent obtained prior to surgical evacuation.
Exclusion criteria
Exclusion criteria: 1. Incomplete or retained products of conception will be excluded from the trial as there are no widely used criteria for deciding which women should have surgical evacuation 2. Suspicion of malignant gestational disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite outcome of unsuccessful procedure or any of the following complications: intrauterine adhesions, infection, severe bleeding or damage to the genital tract. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of individual complications; rate of serious adverse events; need for additional surgical procedure(s) for miscarriage treatment; need for medical management of miscarriage Process outcomes: To obtain estimates for important aspects of the protocol to allow development of a substantive trial, specifically: 1. To derive real-time data on the design aspects of the study: 1.1 Proportion of eligible women of those screened. 1.2 Proportion of eligible women randomised. 1.3 Attrition rates (proportion of women followed-up at 2 to 4 and 4 to 8 weeks) 1.4 Proportion of women switching treatments 2. To derive a realistic understanding of trial processes, in particular: 2.1 Ascertain robustness of the data collection process during and after the surgical procedure. 2.2 Determine the support required in units to ensure successful recruitment 2.3 Determine why patients decline participation or withdraw after randomisation. 3. Evaluation of acceptability to processes and intervention for patients and staff 3.1 Evaluate if outcome measurement tools and processes are acceptable and adequate. 3.2 Acceptability and impact on patients of the interventions. 3.3 Assessment of trial processes, including the choice of outcome measures and impact on staff. | — |
Countries
England, United Kingdom
Contacts
Public ContactLaura Ocansey
Outcome results
None listed