None listed
Conditions
Brief summary
Anaemia is defined as having reduced haemoglobin (an oxygen carrying substance) concentrations in the blood. There are many causes but it is often due to iron deficiency which is common in women, especially during pregnancy. Currently in Australia about one in three pregnant women are anaemic and approximately one in four women undergo birth of their baby by caesarean section surgery – an abdominal surgical operation. This means that some women will undergo both caesarean section surgery and be anaemic. In non-pregnant adults pre-existing anaemia before surgery is associated with an increased risk of postoperative complications such as requiring a blood transfusion, increased risk of blood clots, infection and heart and lung complications. Anaemia is defined differently in men and non-pregnant women, and different again in pregnant people. However, investigators have recently questioned this and have challenged the dogma and traditional view that men, women and pregnant people should have different haemoglobin concentrations. They instead propose that the threshold value for defining anaemia should be the same in all adults and argue this strongly in the context of adults having major surgery. As caesarean section surgery is major surgery, then this would apply to pregnant women. There is only limited information about how anaemia, including the new thresholds proposed for pre-operative anaemia, affects the care of women having caesarean section surgery and the outcomes for their babies. In the future we aim to conduct a large multicentre study to examine the relationship between a pregnant woman’s haemoglobin concentration and her haemoglobin concentration on discharge from hospital to see if anaemia before surgery is associated with low haemoglobin concentrations after birth, and complications for the woman or her baby after caesarean section surgery. Before conducting a large study in this area we need to collect information about the feasibility of such a study including data that can inform sample size calculations regarding these associations. This is the purpose of this feasibility study.
Interventions
Brief name: This will be a single centre prospective observational feasibility study. There is no planned intervention for the women enrolled in the study.
For observational studies:
The condition we are aiming to observe is perioperative anaemia and outcomes in women undergoing caesarean section. We are aiming to observe a small group of women for 3 months following their elective or emergency caesarean section. The main aspects of observation will include the maternal questionnaire's and wei
Brief name: This will be a single centre prospective observational feasibility study. There is no planned intervention for the women enrolled in the study. For observational studies: The condition we are aiming to observe is perioperative anaemia and outcomes in women undergoing caesarean section. We are aiming to observe a small group of women for 3 months following their elective or emergency caesarean section. The main aspects of observation will include the maternal questionnaire's and weight (listed below), in combination with a list of routine hospital collected data. Planned activities. A sample of 60 women undergoing caesarean section will be studied (30 women undergoing elective caesarean section and 30 women undergoing emergency caesarean section) Data collected will include: Hospital collected routine data (Demographics, Age, Comorbidities, perioperative haemaglobin and operative blood loss, fluid and blood product administration) Additional study data, not routinely collected will include: - Maternal weight postoperative weight - Questionnaire data: ---Obstetric Quality of recovery score (Obs QoR-10) ---Likelihood of undertaking a non-routine postoperative blood test to measure haemoglobin concentration - (Yes, No, Unsure) ---Likelihood of undertaking a 6- and 12-week after hospital discharge blood tests to assess haemoglobin concentration - (Yes, No, Unsure) The maternal weight and questionnaire will be performed by a research midwife or research doctor during the inpatient stay, 24 hours prior to discharge from hospital. This will occur as a face to face interview on the hospital ward. The data will only be collected once during the inpatient stay and last approximately 30mins
Sponsors
Mark O'Donnell
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults (greater than or equal to 18 years on day of surgery) Caesarean section surgery only, either elective or emergency Willingness to undertake weight measurement and two questionnaires in the 24 hours prior to hospital discharge
Exclusion criteria
1. Maternal Age (less than 18 years on day of caesarean section) 2. Patient requests her data, or either parent requests the baby’s data, be excluded 3. Women not wanting to have a weight measurement and answer two questionnaires in the 24 hours prior to hospital discharge 4. Planned combined surgery e.g. caesarean section surgery and tubal ligation, caesarean section surgery and hysterectomy, caesarean section surgery and ovarian cystectomy, caesarean section surgery and fetal surgery 5. Women with thalassemia minor or major, sickle cell disease or other haemoglobinopathies 6. Women with known or suspected placental adhesive disorder
Outcome results
None listed