Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000456651
Ethics application status
Approved
Date submitted
20/04/2014
Date registered
1/05/2014
Date last updated
15/10/2021
Date data sharing statement initially provided
15/10/2021
Date results information initially provided
15/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Capacity for informed consent during labour
Scientific title
Amongst pregnant women labouring at term with an uncomplicated pregnancy, does the mode of information provision (written or verbal) and the timing of information provision (36 weeks and labour, or in labour only), influence the capacity of the woman to comprehend and retain information during labour?
Secondary ID [1] 284462 0
Nil
Universal Trial Number (UTN)
U1111-1155-9354
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Informed consent during labour 291699 0
Condition category
Condition code
Reproductive Health and Childbirth 292077 292077 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 292078 292078 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pregnant women with an uncomplicated pregnancy will have their immediate comprehension and retention during labour of pregnancy and non-pregnancy related information tested, with follow-up testing of information retention 18-30 hours post-partum. Women will be enrolled into the study at 35-37 weeks gestation and allocated to one of four groups:
1) Information provided at 35-37 week visit and then again during labour, information given in written form
2) Information provided at 35-37 week visit and then again during labour, information given in verbal form
3) Information provided during labour only, information given in written form
4) Information provided during labour only, information given in verbal form

General description of information provided (in both verbal and written groups):
* Pregnancy and non-pregnancy related word lists
* Summary of information about a pregnancy-related research project
* Summary of information about a non pregnancy-related general information topic
Intervention code [1] 289222 0
Other interventions
Comparator / control treatment
As above, all groups receive provision of information, and the effect on immediate information comprehension during labour is tested, as is recall 24-28 hours post-partum.

Women will be enrolled into the study at 35-37 weeks gestation and allocated to one of four groups:
1) Information provided at 35-37 week visit and then again during labour, information given in written form
2) Information provided at 35-37 week visit and then again during labour, information given in verbal form
3) Information provided during labour only, information given in written form
4) Information provided during labour only, information given in verbal form
Control group
Active

Outcomes
Primary outcome [1] 291951 0
To determine the capacity of pregnant women to comprehend and retain both pregnancy and non-pregnancy related information during labour, as assessed by percentage of questions correctly answered and words remembered from the study's standardised word lists and information provision.
Timepoint [1] 291951 0
Comprehension testing: Immediately after information provision during labour +/- after information provision at 35-37 weeks gestation.
Retention testing: 18-30 hours post-partum.
Secondary outcome [1] 307912 0
To compare the efficacy of information provision at both 35-37 weeks gestation and in labour versus in labour only, by comparing the information comprehension scores during labour for women given information at both the 35-37 week visit and in labour, versus in labour only, as assessed by percentage of questions correctly answered and words remembered from the study's standardised word lists and information provision.
Timepoint [1] 307912 0
During labour immediately after information provision.
Secondary outcome [2] 307913 0
To compare the efficacy of information provision at both 35-37 weeks gestation and in labour versus in labour only, by comparing the information retention scores postpartum for women given information at both the 35-37 week visit and in labour, versus in labour only, as assessed by percentage of questions correctly answered and words remembered from the study's standardised word lists and information provision.
Timepoint [2] 307913 0
18-30 hours postpartum.
Secondary outcome [3] 307914 0
To compare efficacy of verbal versus written provision of information in aiding the capacity of pregnant women to comprehend information given in labour, by comparing the information comprehension scores during labour for women given the study’s standardised word lists and information provision in written versus verbal format in labour, as assessed by percentage of questions correctly answered and words remembered from the study's standardised word lists and information provision.
Timepoint [3] 307914 0
During labour immediately after information provision (in either written or verbal format).
Secondary outcome [4] 307915 0
To compare efficacy of verbal versus written provision of information in aiding the capacity of pregnant women to retain information given in labour, by comparing the information retention scores postpartum for women given the study’s standardised word lists and information provision in written versus verbal format in labour, as assessed by percentage of questions correctly answered and words remembered from the study's standardised word lists and information provision.
Timepoint [4] 307915 0
18-30 hours postpartum.
Secondary outcome [5] 307916 0
To compare the capacity of pregnant women to comprehend and retain pregnancy versus non-pregnancy related information at 35-37 weeks gestation and during labour, as assessed by percentage of questions correctly answered and words remembered from the study's standardised word lists and information provision.
Timepoint [5] 307916 0
Comprehension testing: Immediately after information provision during labour +/- after information provision at 35-37 weeks gestation.
Retention testing: 18-30 hours post-partum.

Eligibility
Key inclusion criteria
1) Adult pregnant women at 35+0 – 36+6 weeks of gestation at time of study enrolment
2) Normal antenatal progress
3) Baseline ability to retain information i.e. no reason to believe woman is not usually capable of giving informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Requiring interpreter to give informed consent to participate
2) Major maternal or fetal pregnancy complication e.g. pre-eclampsia, congenital abormality

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once person assessing eligibility for trial inclusion has obtained informed consent to participate, locked cabinet is accessed to obtain envelope corresponding to participant number (sequentially from 1 to 250) which contains participant allocation. The envelopes are sealed, opaque, and sequentially numbered by a person not otherwise involved in trial recruitment/daily conduct of trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). Allocation number from 1 to 250 generated (i.e. larger than proposed number of study participants even after allowing for dropout, to minimise risk that randomisation sequence can be guessed as required sample size approached).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size for this pilot study is approximately 100 (randomisation to continue until 25 subjects in each of the 4 arms). As no similar previous work has been done, standard power calculation regarding differences in comprehension and recall is not practical, hence the need for a pilot study to (a) provide data on which to base power calculations and sample size needed for a comprehensive study (b) assess the feasibility of this areas of research and likely speed of recruitment to a larger study.

Basic data will be presented as simple tabulation. Categorical data will be analysed using Chi-squared test or Fisher’s exact test as appropriate. Continuous data will be analysed using t-test or ANOVA will be used as required. Appropriate adjustment will be made for multiple comparisons.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
12/05/2014
Actual
19/05/2014
Date of last participant enrolment
Anticipated
Actual
28/11/2014
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
100
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2352 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 8016 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 289117 0
Charities/Societies/Foundations
Name [1] 289117 0
Royal Hospital for Women Foundation
Country [1] 289117 0
Australia
Primary sponsor type
Hospital
Name
Royal Hospital for Women
Address
Locked Bag 2000
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 287778 0
University
Name [1] 287778 0
University of New South Wales
Address [1] 287778 0
UNSW Australia
UNSW Sydney, NSW 2052
Australia
Country [1] 287778 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290898 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 290898 0
Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 290898 0
Australia
Date submitted for ethics approval [1] 290898 0
Approval date [1] 290898 0
03/04/2014
Ethics approval number [1] 290898 0
13/289

Summary
Brief summary
Considering the background of physical and emotional stressors in labour, it is clear that there are ethical considerations in obtaining consent for research from women at this time. Although there is some literature on the validity of informed consent by women in labour, much of it is from an anaesthetics perspective only. Additionally, despite the availability of literature on women’s opinions of pregnancy and labour, there is a gap in knowledge about women’s ability to comprehend and retain information during labour. The proposed study focuses on addressing this gap and providing an evidence base regarding ethically obtaining consent, including research consent, in labour. Given the current paucity of evidence in this area, the study initially proposed is pilot in nature to ascertain the feasibility of a larger, comprehensive study and to confirm the utility of our proposed study methodology.

The primary purpose of the study is to determine the capacity of pregnant women to comprehend (pregnancy and non-pregnancy related) and retain information during labour. This will be assessed, using healthy pregnant volunteers (pregnant women with no major pregnancy complications who are willing to undergo testing at approximately 36 weeks of pregnancy, in labour, and approximately 24 hours after the birth of their baby), through administration of standardised information and word lists, followed by testing of comprehension of the information and recall of the word lists. Participating women will be allocated to one of four groups:
1) Information given at both 35-37 weeks of pregnancy (at time of study enrolment) and during labour, information in written format
2) Information given at both 35-37 weeks of pregnancy (at time of study enrolment) and during labour, information in verbal (spoken) format
3) Information given only during labour, information in written format
4) Information given only during labour, information in verbal (spoken) format.

Testing of immediate comprehension/recall will occur at enrolment at 35-37 weeks of pregnancy (if participant is allocated to one of the first 2 groups) and during labour (all participants). Testing of later recall (of information given during labour) will occur approximately 24 hours after the birth of the baby.

The main study hypothesis is that the ability of women to comprehend and retain information will not be significantly affected by labour.

Secondary aims of the study include comparing the efficacy of written versus verbal information format, and efficacy of provision of relevant information at approximately 36 weeks of pregnancy then again in labour versus information provision in labour only. The study will also consider the effect of other factors (e.g. epidural analgesia vs not, first baby or subsequent baby, woman's baseline behavioural state score) on information comprehension and recall.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47834 0
Prof Alec Welsh
Address 47834 0
School of Women's and Children's Health, UNSW Medicine
Level 1, Royal Hospital for Women
Barker St
Randwick NSW 2031
Country 47834 0
Australia
Phone 47834 0
+61293826272
Fax 47834 0
Email 47834 0
[email protected]
Contact person for public queries
Name 47835 0
Dr Melissa Chang
Address 47835 0
School of Women's and Children's Health, UNSW Medicine
Level 0, Royal Hospital for Women
Barker St,
Randwick NSW 2031
Country 47835 0
Australia
Phone 47835 0
+61293826406
Fax 47835 0
_61293826444
Email 47835 0
[email protected]
Contact person for scientific queries
Name 47836 0
Dr Amanda Henry
Address 47836 0
School of Women's and Children's Health, UNSW Medicine
Level 1, Royal Hospital for Women,
Barker St,
Randwick NSW 2031
Country 47836 0
Australia
Phone 47836 0
+61293826272
Fax 47836 0
Email 47836 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


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.