Gynaecology and Reproductive Health studies

Full title: A Prospective, Single-Arm Multi-Centre Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Upper Gastrointestinal, Lower Gastrointestinal, and Gynaecological Procedures

Summary: This prospective, single-arm, multi-centre study is being conducted to see how well the ENSEAL X1 Curved Jaw Tissue Sealer (“ENSEAL X1”) and Generator G11 device work in surgical procedures. The ENSEAL X1 device is a surgical instrument used to cut and seal blood vessels, and cut, grasp, and dissect tissue during surgery. The Generator G11 device provides power to operate the ENSEAL X1 device.
Potential participants may be invited to the study if they have a medical condition requiring either a gastrointestinal (GI) or gynaecological surgical procedure where the study device is used for the cutting and sealing of blood vessels.

All participants taking part in the study will have surgery according to their surgeon’s routine practice. The only difference is that the surgeon will use the ENSEAL X1 device to cut and seal blood vessels, and cut, grasp, and dissect tissue during surgery in place of the device they would normally use. There are no additional medical procedures or tests required by participants.

It is hoped that a minimum of 164 patients (max. 180) across centres in the United States and/or European Union and/or United Kingdom will be enrolled in the study across various upper GI, lower GI and gynaecological procedures.

Full title: Induction of labour for predicted macrosomia

Summary: To investigate the potential benefit of intervention on the prevention of shoulder dystocia and associated birth injury, through a prospective, multi-centre randomised controlled trial for of induction
of labour at 39 weeks gestation (39.0-39.6 days) versus expectant management, of foetuses that are large for gestational age according to ultrasound EFW at 35-38 weeks.

Full title: Maternal and Perinatal Outcomes of Pandemic Influenza in Pregnancy

Summary: This NIHR supported study is a national study of women hospitalised with confirmed COVID-19 in pregnancy. The study, funded by the NIHR, will use the UK Obstetric Surveillance System (UKOSS) to collect information about all pregnant women admitted to hospital who are confirmed to have the virus infection. The information will be analysed on a continuous basis to inform ongoing guidance for women and maternity staff as we respond to the pandemic. Specifically, the study will describe incidence, management and outcomes of COVID-19 in pregnancy and identify factors associated with better outcomes for women and their babies.

Anonymous information will be collected through the existing UK Obstetric Surveillance System (UKOSS) reporters, who are based in all maternity units in the UK. Reporters have been sent a live link to allow them to notify cases and complete an anonymous data collection form.

Full title: Pregnancy and Neonatal Outcomes in COVID-19: A global registry of women with suspected or confirmed SARS-CoV-2 infeciton in pregnancy and their neonates, understanding natural history to guide treatment and prevention

Summary: The current coronavirus outbreak (COVID-19) is likely to affect hundreds of pregnant women globally. Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratoy Syndrome (SARS), also coronaviruses, caused more severe illness - particularly lung infections- in pregnant vs. non-pregnant women. There has been a report of nine women affected by COVID-19 in the latter third of their pregnancy, many more are likely to be affected. There is a data-gap on the effect of SARs-CoV-2 infection and COVID-19 at other stages of pregnancy e.g. early pregnancy and its effect on the unborn and newborn baby. Maternity services and individual maternity centres are currently developing their responses using national and WHO guidance for non-pregnant women.

PAN-COVID will develop a global database detailing a number of outcomes (death of the baby or mother, stillbirth, miscarriage, pregnancy complications, gestational age at delivery, delivery method and testing the baby for SARS-CoV-2).
The aim of this database is to understand the natural history of SARS-CoV-2 and COVID-19 and the impact on mothers and their babies to guide both treatment and prevention.

A multicentre randomised controlled trial, with nested process evaluation, to test the clinical and cost-effectiveness of self-management of vaginal pessaries to treat pelvic organ prolapse, compared to standard care to improve women’s quality of life.

Summary: Pelvic organ prolapse (prolapse) is a common condition in women where the bladder, bowel or womb descend into the vagina and cause symptoms that adversely affect quality of life. Many women choose a vaginal pessary to treat their prolapse symptoms. The pessary is usually fitted at a gynaecological clinic and the woman returns to clinic for pessary changes. It is possible that women could remove, clean and reinsert their pessary themselves at home, thus offering them more confidence in their ability to manage their own health (self-management). This study aims to assess if self-management of prolapse using a vaginal pessary is more effective at improving women’s quality of life than standard follow-up care (visiting the clinic every six months). Women with any severity or kind of prolapse and who have used a pessary for at least two weeks will be invited to take part. They will receive written information about the study and if willing to take part they will be randomly assigned to either self-management or standard care. Women in the standard care group would be seen approximately every 6 months in a clinic for pessary removal and reinsertion. Woman in the self-management group will have a thirty minute appointment with a healthcare professional to teach them the necessary pessary care. Woman will asked to change their pessary within two weeks of the appointment and they will be telephoned to assess their ability to self manage. They will also be given a phone number to call if they have any pessary problems. Women will be asked to fill out questionnaires at the start of the study and 6, 12 and 18 months later. To help understand how and why aspects of self-management may or may not work we will record some self-management sessions and interview some women and healthcare professionals.