Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001172594
Ethics application status
Approved
Date submitted
30/08/2024
Date registered
25/09/2024
Date last updated
25/09/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
PAUSEMATTERS Study: Exploring the impact of natural pauses in childbirth on the mother's and newborn's health
Scientific title
Evaluation of the impact of physiological plateaus in childbirth on the mother's and newborn's health in planned homebirths in Western Australia
Secondary ID [1] 312756 0
Grant number: ECU-G1007052
Universal Trial Number (UTN)
Trial acronym
PAUSEMATTERS Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physiological birth 334797 0
Condition category
Condition code
Reproductive Health and Childbirth 331357 331357 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a prospective observational cohort study with no intervention. The study applies a co-design approach with ongoing engagement of community members across all study phases.

Women who plan a homebirth with a collaborating midwife in Western Australia are invited to participate in this study on a strictly voluntary basis. Women who chose to participate in this study continue to be cared for by their chosen midwife/midwives with no change in the care that is provided to them (this study involves no intervention).
After the woman gives birth, her midwife completes a questionnaire (approx. 20 minutes online or approx. 30 minutes via interview), providing information about the woman's labour and maternal and neonatal birth outcomes. The questionnaire supplements information that is included in the midwives' routinely taken birth records (NOCA form ["Notification of Case Attendance"] and handwritten birth notes), of which copies are also provided to the research team. This data (NOCA form + birth notes + questionnaire) is shared with the research team by the midwife within two weeks after the woman's birth and contains the following key data items:
1. Labour pattern and key events (such as labour onset, rupture of membranes)
2. Birth outcomes for mother and infant/s (such as birth mode, intrapartum core outcome set)
3. Physiological plateaus (such as occurrence of slowing/pausing/stopping labour patterns, including the timing and duration of these events)
4. Birth environment (such as birth setting, people present)
5. Medical interventions during labour and after birth (such as labour augmentation)
6. Maternal and or fetal/neonatal complications

Subsequently, within 12 weeks following birth, the woman who birthed provides additional information about her birth experience (same data items as above, but from the woman's perspective). Birth partners are also invited to co-participate in this study if the participating woman prefers this. Data collection from the woman who birthed takes place via questionnaire (online, approximately 20 minutes) or interview (face-to-face/online/phone, approximately 30 minutes), based on the woman's preference.

The total duration of participation is from enrolment in this study (at any point in pregnancy >12 weeks gestation) until up to 12 weeks after birth.
Intervention code [1] 329288 0
Not applicable
Comparator / control treatment
This study has no control group.
Within the cohort, birth outcomes may be compared between women who did experience physiological plateaus during labour and women who did not experience physiological plateaus during labour, subject to sub-group sample sizes.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339118 0
Mode of birth assessed using standardised classification of birth modes (spontaneous vaginal birth, instrumental birth via ventouse/forceps, elective/emergency caesarean section)
Timepoint [1] 339118 0
At birth (data collected within 2 weeks postpartum)
Primary outcome [2] 339119 0
Maternal labour and birth complications using standardised classification of labour complications (including but not limited to shoulder dystocia, postpartum haemorrhage, perineal injury)
Timepoint [2] 339119 0
At birth (primary timepoint), up to 6 weeks postpartum for adverse outcomes (data collected within 12 weeks postpartum)
Primary outcome [3] 339120 0
Fetal/neonatal birth complications using standardised classification of fetal/neonatal birth complications (including but not limited to APGAR score, need for resuscitation, admission to neonatal intensive care unit)
Timepoint [3] 339120 0
At birth (primary timepoint), up to 6 weeks postnatally for adverse outcomes (data collected within 12 weeks after postnatally)
Secondary outcome [1] 438968 0
Response to plateaus during labour measured using a question with a list of options (no action initiated, various conservative actions initiated, various medical interventions initiated, transfer to obstetric care initiated in response to a plateau in labour)
Timepoint [1] 438968 0
During labour (data collected within 2 weeks following birth from the midwife and within 12 weeks following birth for the women)
Secondary outcome [2] 438969 0
Transfer to hospital (for any reason) measured by data-linkage of NOCA form, birth notes, and an open-response question about the reasons for transfer
Timepoint [2] 438969 0
During labour (data collected within 2 weeks following birth from the midwife and within 12 weeks following birth for the women)
Secondary outcome [3] 438970 0
Augmentation of labour (including artificial rupture of membranes and/or oxytocin administration) measured by data-linkage of NOCA form and birth notes
Timepoint [3] 438970 0
During labour (data collected within 2 weeks following birth)

Eligibility
Key inclusion criteria
Inclusion criteria for primary participant pool (women who birth and their newborns):

1. women aged greater than or equal to 18 years
2. resident in Western Australia (WA) at the time of data collection
3. pregnant greater than or equal to 12 weeks of gestation (12 weeks and 0 days or longer)
4. birth planned at home, or commenced at home, with the support of a midwife (see note below)
5. consent to participate (voluntary participation)

Note: Women who commence a birth at home with the support of a midwife and transfer to hospital during labour (e.g., due to a change of preferences, or due to emerging risk factors), remain eligible for participation irrespective of the eventual birth setting.

Note: All neonates born to women who participate in this study will be enrolled in this study as participants, and basic neonatal data (e.g. APGAR score) will be collected via the maternal birth record.

Inclusion criteria for secondary participant pool (co-participants, birth partner/s):

1. birth partner, defined as a person who was chosen by the participating woman to provide support during birth (e.g., spouse, family member, friend, doula, etc.)
2. was present during labour and/or birth
3. aged greater than or equal to 18 years
4. consent to participate
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for primary participant pool (women who birth and their newborns):

1. planned birth at a hospital or birth centre
2. birth without any support of a midwife (see note below)
3. preterm birth (below 37 weeks and 0 days gestation)

Note: Women who have planned a homebirth with the support of a midwife and end up birthing before the midwife arrives (so-called birth before attendance) remain eligible for participation. Women who plan a birth without the support of a midwife (so-called freebirth) are ineligible to participate in this study.

Exclusion criteria for secondary participant pool (co-participants, birth partner/s):
1. the participating woman prefers her birth partner/s not to be involved in this study
2. unavailable during the time of the interview or unable to complete online questionnaire

Study design
Purpose
Natural history
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculation:
The target number of primary participants (women who give birth) is expected to be 73 based on a 10% error margin and an anticipated 265 home births commencing in Western Australia annually, in the study period. This was calculated on the following baseline information: 221 homebirths were recorded in Western Australia for 2023, with similar rates in the two previous years (2021: N=200; 2022: N=237). Since there is a lack of reliable data on how many women commence birth at home and ultimately transfer to the hospital in Western Australia, we considered a pragmatic yet conservative approach of anticipating 20% of transfers, yielding the target population of approximately 265 women. Slovin‘s formula was implemented to determine the sample size of 73 participants. Data will be collected during a 17-month period (Aug 2024 to Dec 2025).

Analysis:
All outcomes and characteristics will be summarised using proper descriptive statistics and graphs aligning with the variable type. Predictors of maternal and neonatal outcomes will be investigated through multivariable regression modelling. The variable type that defines the outcome will determine the proper regression model. Investigating the assumption(s) that revolve around the initially selected regression model will further determine the final model. Missing data will be properly addressed using recent advances in the relevant methodology.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/09/2024
Date of last participant enrolment
Anticipated
22/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
73
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317187 0
University
Name [1] 317187 0
Edith Cowan University (ECU)
Country [1] 317187 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
Country
Australia
Secondary sponsor category [1] 319719 0
Individual
Name [1] 319719 0
Dr Marina Weckend
Address [1] 319719 0
Country [1] 319719 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315932 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 315932 0
Ethics committee country [1] 315932 0
Australia
Date submitted for ethics approval [1] 315932 0
05/06/2024
Approval date [1] 315932 0
06/08/2024
Ethics approval number [1] 315932 0
2023-04863-WECKEND

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136258 0
Dr Marina Weckend
Address 136258 0
Edith Cowan University, School of Nursing and Midwifery, 270 Joondalup Drive, Joondalup 6027, WA
Country 136258 0
Australia
Phone 136258 0
+61491601852
Fax 136258 0
Email 136258 0
[email protected]
Contact person for public queries
Name 136259 0
Marina Weckend
Address 136259 0
Edith Cowan University, School of Nursing and Midwifery, 270 Joondalup Drive, Joondalup 6027, WA
Country 136259 0
Australia
Phone 136259 0
+61491601852
Fax 136259 0
Email 136259 0
[email protected]
Contact person for scientific queries
Name 136260 0
Marina Weckend
Address 136260 0
Edith Cowan University, School of Nursing and Midwifery, 270 Joondalup Drive, Joondalup 6027, WA
Country 136260 0
Australia
Phone 136260 0
+61491601852
Fax 136260 0
Email 136260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Curated, de-identified data will be shared via a suitable data repository (ECU Research Online). Consent for data sharing is optional for participants in this study. Therefore, the publication of data includes only data of participants who consented to data sharing.
When will data be available (start and end dates)?
Data will be published in a repository following the scientific publication of the main results. No end date applies.
Available to whom?
Mediated access on a case-by-case basis at the discretion of the primary investigator.
Available for what types of analyses?
Not pre-specified.
How or where can data be obtained?
Mediated access via Edith Cowan University's institutional repository Research Online: https://ro.ecu.edu.au/


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.