Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000983707
Ethics application status
Approved
Date submitted
8/07/2022
Date registered
13/07/2022
Date last updated
18/08/2022
Date data sharing statement initially provided
13/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring first time mothers' knowledge and experience of induction of labour
Scientific title
Exploring first time mothers' knowledge and experience of induction of labour
Secondary ID [1] 307515 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Induction of labour 326944 0
Childbirth 326950 0
Condition category
Condition code
Reproductive Health and Childbirth 324128 324128 0 0
Childbirth and postnatal care
Reproductive Health and Childbirth 324129 324129 0 0
Antenatal care
Reproductive Health and Childbirth 324130 324130 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 324131 324131 0 0
Normal pregnancy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be asked to complete a survey about their experiences and the information they received, prior to commencing the induction of labour process. This survey will be completed when participants have given birth and are in hospital on the postnatal ward. The planned survey has been specifically developed for this study and is expected to take 10-15 minutes for participants to complete.
A further group of these participants (approximately 15) will participate in an interview when they are are 6 to 8 weeks postpartum for a qualitative study of consumer experiences. The first 15 participants who consent to complete this interview will be asked to attend an interview via Microsoft Teams (online) call with a research midwife (one-on-one). It is expected that this interview will take approximately 30-45 minutes. Semi-structured questions have been developed specifically for this study, to use as a guide for this interview. Participants will be informed prior to call commencing that this interview will be audio-recorded for transcription and analysis purposes.
Intervention code [1] 323986 0
Not applicable
Comparator / control treatment
Not applicable/no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331950 0
Participant's experienced level of preparedness, prior to commencing the induction of labour process. This will be a quantitative assessment and it will be measured using a questionnaire, specifically designed for this study.
Timepoint [1] 331950 0
Baseline (prior to hospital discharge).
Primary outcome [2] 331967 0
Participant's experienced level of preparedness, prior to commencing the induction of labour process. This will be a qualitative assessment and it will be measured using an audio-recorded, one-on-one semi-structured interview with a research midwife and specifically designed for this study and only in a subgroup of participants (approximately 15).
Timepoint [2] 331967 0
6 to 8 weeks postpartum.
Secondary outcome [1] 411707 0
Number of induction of labour methods required.
This outcome will be assessed by electronic medical record review.
Timepoint [1] 411707 0
Birth
Secondary outcome [2] 411708 0
If antenatal admission to hospital was required.
This outcome will be assessed by electronic medical record review.
Timepoint [2] 411708 0
Birth
Secondary outcome [3] 411709 0
Length of labour stages.
This outcome will be assessed by electronic medical record review.
Timepoint [3] 411709 0
Baseline/post-birth.
Secondary outcome [4] 411710 0
Mode of birth, following induction of labour.
This outcome will be assessed by electronic medical record review.
Timepoint [4] 411710 0
Birth
Secondary outcome [5] 411711 0
Neonate height.
This outcome will be assessed by electronic medical record review.
Timepoint [5] 411711 0
Birth
Secondary outcome [6] 411712 0
Length of postnatal admission to hospital.
This outcome will be assessed by electronic medical record review.
Timepoint [6] 411712 0
6-8 weeks postpartum
Secondary outcome [7] 411713 0
What factors influenced participant’s decision to proceed with induction of labour, This will be a quantitative assessment, as it will be measured using a questionnaire, specifically designed for this study.
Timepoint [7] 411713 0
Baseline
Secondary outcome [8] 411714 0
Women’s perspectives on induction of labour as a shared-decision making process. This will be a composite secondary outcome, as it will be measured by a questionnaire, specifically designed for this study and a qualitative assessment, measured using an audio-recorded, one-on-one semi-structured interview with a research midwife, specifically designed for this study and only in a subgroup of participants (approximately 15).
Timepoint [8] 411714 0
Baseline and 6-8 weeks postpartum
Secondary outcome [9] 411715 0
Participant's satisfaction with the level of information received prior to commencement of induction of labour and whether they felt informed consent was adequately provided. This will be a quantitative assessment as it will be measured by a questionnaire, specifically designed for this study.
Timepoint [9] 411715 0
Baseline
Secondary outcome [10] 411716 0
Participants experience of labour support during their induction of labour and birth. This will be a composite secondary outcome, as it will be measured by a questionnaire, specifically designed for this study, and a qualitative assessment, measured using an audio-recorded, one-on-one semi-structured interview with a research midwife, specifically designed for this study and only in a subgroup of participants (approximately 15).
Timepoint [10] 411716 0
Baseline and 6-8 weeks postpartum
Secondary outcome [11] 411717 0
Rates of breastfeeding, upon discharge from hospital postnatal ward.
This outcome will be assessed by electronic medical record review.
Timepoint [11] 411717 0
6 to 8 weeks postpartum
Secondary outcome [12] 411743 0
What factors influenced participant’s decision to proceed with induction of labour, This will be a qualitative assessment and it will be measured using an audio-recorded, one-on-one semi-structured interview with a research midwife and specifically designed for this study and only in a subgroup of participants (approximately 15).
Timepoint [12] 411743 0
6 to 8 weeks postpartum
Secondary outcome [13] 411744 0
Participant's satisfaction with the level of information received prior to commencement of induction of labour and whether they felt informed consent was adequately provided. This will be a qualitative assessment and it will be measured using an audio-recorded, one-on-one semi-structured interview with a midwife and specifically designed for this study and only in a subgroup of participants (approximately 15).
Timepoint [13] 411744 0
6 to 8 weeks postpartum
Secondary outcome [14] 411745 0
Where did participants source patient information about induction of labour. This will be a quantitative assessment, measured by a questionnaire specifically designed for this study.
Timepoint [14] 411745 0
Baseline
Secondary outcome [15] 411746 0
Perineal repair required at birth. This outcome will be assessed by electronic medical record review.
Timepoint [15] 411746 0
Birth
Secondary outcome [16] 411747 0
Postpartum hemorrhage (primary). This outcome will be assessed by electronic medical record review.
Timepoint [16] 411747 0
Birth
Secondary outcome [17] 411748 0
Number of antenatal education sessions attended by participants. This will be a quantitative assessment, measured by a questionnaire specifically designed for this study,
Timepoint [17] 411748 0
Baseline
Secondary outcome [18] 411809 0
Neonate weight.
This outcome will be assessed by electronic medical record review.
Timepoint [18] 411809 0
Birth
Secondary outcome [19] 411810 0
Neonate head circumference.
This outcome will be assessed by electronic medical record review.
Timepoint [19] 411810 0
Birth.

Eligibility
Key inclusion criteria
Primiparous
Had induction of labour
Able to read and understand English language
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who are too unwell to participate or admitted to ICU
Women who have critically unwell babies admitted to NICU/Newborn Care Department
Women who have had induction of labour for stillborn baby
Women who decline participation when approached for study
Twin/Multiple pregnancy

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Following a preliminary estimation that 50% of the study participants would feel adequately prepared for their induction of labour (primary outcome), the calculated sample size for this study using a confidence interval set at 95% and P Value <0.05 is 100 participants.
For the qualitative section of this mixed-methods study, the sample size calculation for interviews is 15 participants, or until saturation with the views from participants has been reached. For the purposes of this study, data saturation will occur when 3 or more interviews produce the same themes.
Descriptive statistics will be used to present the basic characteristics of the women and neonates. Student T-tests will be utilised to compare baseline characteristics and for non-parametric data, Mann Whitney U and Kruskal-Wallis analysis will be undertaken. Contingency tables will be compared utilising chi square analysis and a p value < 0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/08/2022
Actual
15/08/2022
Date of last participant enrolment
Anticipated
2/01/2023
Actual
Date of last data collection
Anticipated
27/02/2023
Actual
Sample size
Target
100
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22780 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 38062 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311796 0
Hospital
Name [1] 311796 0
Royal Prince Alfred Hospital
Country [1] 311796 0
Australia
Funding source category [2] 311820 0
Self funded/Unfunded
Name [2] 311820 0
Alexandra Emerton
Country [2] 311820 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital - Women and Babies
Address
RPAH Women and Babies, 50 Missenden road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 313273 0
None
Name [1] 313273 0
Address [1] 313273 0
Country [1] 313273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311239 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 311239 0
Research Ethics and Governance Office (REGO)
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 311239 0
Australia
Date submitted for ethics approval [1] 311239 0
04/07/2022
Approval date [1] 311239 0
08/08/2022
Ethics approval number [1] 311239 0
X22-0208

Summary
Brief summary
This will be a mixed-method, observational study and will be undertaken at the Royal Prince Alfred Hospital, Women and Babies Department.

The study hypothesis is: Women feel more prepared for the induction of labour process when they access antenatal education, receive adequate clinical information and feel part of a shared-decision making process in the antenatal period. Women who feel prepared and satisfied with their decision to proceed with induction of labour feel more supported and greater contentment with their birth outcomes.

The study will be conducted via a participant questionnaire (quantitative) and an audio-recorded interview with women at 6 to 8 weeks postpartum (qualitative).
Electronic medical notes will also be reviewed to measure pregnancy and birth outcome data.
The purpose of this design is to review the association between women who access antenatal education services, the reason given for induction of labour, women’s perspectives and experiences with the induction of labour process and delivery outcomes.

The sample size calculation is approximately 100 participants for the survey and 15 participants for the interview, or until saturation with themes has been reached.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120422 0
Ms Alexandra Emerton
Address 120422 0
RPAH Women and Babies Department
Missenden road, Camperdown NSW 2050
Country 120422 0
Australia
Phone 120422 0
+61 2 9515 5119
Fax 120422 0
Email 120422 0
alexandra.emerton@health.nsw.gov.au
Contact person for public queries
Name 120423 0
Ms Alexandra Emerton
Address 120423 0
RPAH Women and Babies Department
Missenden road, Camperdown NSW 2050
Country 120423 0
Australia
Phone 120423 0
+61 2 9515 5119
Fax 120423 0
Email 120423 0
alexandra.emerton@health.nsw.gov.au
Contact person for scientific queries
Name 120424 0
Ms Alexandra Emerton
Address 120424 0
RPAH Women and Babies Department
50 Missenden road, Camperdown NSW 2050
Country 120424 0
Australia
Phone 120424 0
+61 2 9515 5119
Fax 120424 0
Email 120424 0
alexandra.emerton@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected during the trial.
When will data be available (start and end dates)?
Beginning 3 months following publication, no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal and at discretion of Prinicipal Investigator.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approval by Prinicipal Investigator (alexandra.emerton@health.nsw.gov.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16582Informed consent form  alexandra.emerton@health.nsw.gov.au 384341-(Uploaded-08-07-2022-14-55-30)-Study-related document.docx



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.