Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001066875
Ethics application status
Approved
Date submitted
30/06/2021
Date registered
12/08/2021
Date last updated
15/07/2022
Date data sharing statement initially provided
12/08/2021
Date results information initially provided
15/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternal Anaemia and Postoperative Outcomes After Caesarean Section Surgery - The MAPOC Study (Feasibility Study)
Scientific title
Maternal Anaemia and Postoperative Outcomes After Caesarean Section Surgery - The MAPOC Study (Feasibility Study)
Secondary ID [1] 304659 0
None
Universal Trial Number (UTN)
U1111-1267-3825
Trial acronym
MAPOC trial
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Anaemia 322615 0
Pregnancy or Post partum 322616 0
Caesarean section 322617 0
Condition category
Condition code
Anaesthesiology 320231 320231 0 0
Anaesthetics
Reproductive Health and Childbirth 320232 320232 0 0
Antenatal care
Reproductive Health and Childbirth 320233 320233 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 320234 320234 0 0
Normal pregnancy
Reproductive Health and Childbirth 320235 320235 0 0
Fetal medicine and complications of pregnancy
Blood 320236 320236 0 0
Anaemia

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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
Intervention code [1] 321020 0
Diagnosis / Prognosis
Intervention code [2] 321021 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328100 0
As a feasibility study the primary aims/outcomes are to determine feasibility for a larger trial. Thus the primary outcomes for this trial are:
- The number of eligible participants per week based on review of medical and theatre booking records and case numbers collected as part of trial
Timepoint [1] 328100 0
3 months post caesarean section
Primary outcome [2] 328101 0
- The number of participants who adhere to the study protocol and average time it takes to perform the pre-discharge protocol, based on review of case report forms and medical records
Timepoint [2] 328101 0
3 months post caesarean section
Primary outcome [3] 328300 0
the proportion of participants who agree to be part of the study, including consenting to a postoperative blood test (haemoglobin concentration measurement)
Timepoint [3] 328300 0
3 months post caesarean section
Secondary outcome [1] 397628 0
Change in haemoglobin concentration perioperatively, using blood samples that have been collected as part of routine perioperative management- it is NOT a part of the trial that pathology tests will be done in addition to those that are collected by the treating medical team as part of standard care
Timepoint [1] 397628 0
72 hours post caesarean section
Secondary outcome [2] 397629 0
Quality of recovery as assessed by Obstetric QoR-10 score
Timepoint [2] 397629 0
24 hours prior to hospital discharge
Secondary outcome [3] 397630 0
Maternal perioperative weight change (kg)
Timepoint [3] 397630 0
Immedaitely pre-op to 24 hours prior to hospital discharge

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Over a four-month period we expect 640 women to undergo caesarean section surgery at The Royal Women’s Hospital. This study aims to recruit 60 women during this time (one in 10 women approximately, 30 women undergoing elective caesarean section surgery and 30 women undergoing emergency caesarean section surgery).

We will consider that a larger study is feasible if:
Recruitment of this number of participants occurs
80% of participants adhere to the study protocol ie undergo weight measurements and answer the questionnaires
80% of women consent to having postoperative haemoglobin concentration measurements
The average time to undertake the pre-discharge study protocol is less than 1-hour

This sample size will also enable a comparison of women undergoing elective caesarean section surgery with women undergoing emergency caesarean section surgery with respect to changes in mean haemoglobin concentration differences (from before to after surgery). We hypothesize that women who undergo emergency caesarean section surgery will have a greater change (decrease) in haemoglobin concentrations from before to after surgery than women undergoing elective caesarean section. This may be associated with worse adverse outcomes after surgery which can then be explored as a subgroup in future studies. Using data from our pilot study of all women undergoing caesarean section surgery the mean difference of haemoglobin concentration from before to after surgery was 15.5 g/L with a standard deviation of 11.8 g/L. Using these data, and using an a value of 0.01, we will be able to reject the null hypothesis (that the mean haemoglobin concentration difference of both groups of women are equal) with a probability (power) of 0.983.

For the large multicentre study we will include a biostatistician. Multiple linear regression will be used to examine the associations between the continuous variables of pre-operative and discharge haemoglobin concentration with appropriate transformation of the outcome and/or predictor variable if skewed. It will also be used to examine the associations between pre-operative haemoglobin concentration and other maternal and neonatal outcomes with adjustment for other maternal characteristics such as age and body mass index, if necessary.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2021
Actual
22/11/2021
Date of last participant enrolment
Anticipated
6/12/2021
Actual
24/01/2022
Date of last data collection
Anticipated
24/01/2022
Actual
27/01/2022
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19848 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 34546 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 309027 0
Hospital
Name [1] 309027 0
Royal Women's Hospital (Melbourne)
Country [1] 309027 0
Australia
Primary sponsor type
Individual
Name
Mark O'Donnell
Address
Royal Women's Hospital- 20 Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 309962 0
None
Name [1] 309962 0
Address [1] 309962 0
Country [1] 309962 0
Other collaborator category [1] 281896 0
Individual
Name [1] 281896 0
Professor Alicia Dennis
Address [1] 281896 0
Royal Women's Hospital- 20 Flemington Rd, Parkville VIC 3052
Country [1] 281896 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308907 0
Royal Women's Hospital (Parkville) Human Research Ethics Committee
Ethics committee address [1] 308907 0
20 Flemington Rd, Parkville VIC 3052
Ethics committee country [1] 308907 0
Australia
Date submitted for ethics approval [1] 308907 0
05/07/2021
Approval date [1] 308907 0
01/09/2021
Ethics approval number [1] 308907 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes
- 'Funding' of the study by the Royal Womens Hospital is in relation to the non-clinical/study time given to the primary investigator and co-investigators by the health service. no addition monetary support has been provided at this stage

Contacts
Principal investigator
Name 112298 0
Dr Mark O'Donnell
Address 112298 0
Royal Women's Hospital
20 Flemington Rd, Parkville VIC 3052
Country 112298 0
Australia
Phone 112298 0
+61421231381
Fax 112298 0
Email 112298 0
[email protected]
Contact person for public queries
Name 112299 0
Dr Mark O'Donnell
Address 112299 0
Royal Women's Hospital
20 Flemington Rd, Parkville VIC 3052
Country 112299 0
Australia
Phone 112299 0
+61421231381
Fax 112299 0
Email 112299 0
[email protected]
Contact person for scientific queries
Name 112300 0
Dr Mark O'Donnell
Address 112300 0
Royal Women's Hospital
20 Flemington Rd, Parkville VIC 3052
Country 112300 0
Australia
Phone 112300 0
+61421231381
Fax 112300 0
Email 112300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Observation feasibility study by design. No individual participant data that is thought to be potentially identifiable will be shared due to ethical reasons of privacy and confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.