Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000973415
Ethics application status
Approved
Date submitted
13/06/2016
Date registered
25/07/2016
Date last updated
25/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The water birth versus land birth study for pregnant women at low-risk of complications
Scientific title
Water birth Access at Term to Estimate Risks and Benefits In Research cohorTs in Hospital (WATERBIRTH): prospective cohort feasibility study
Secondary ID [1] 289429 0
Nil known
Universal Trial Number (UTN)
U1111-1184-2421
Trial acronym
WATERBIRTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Waterbirth 299108 0
Condition category
Condition code
Reproductive Health and Childbirth 299134 299134 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Weeks
Description of intervention(s) / exposure
Participants who intend to have a water birth on admission to birth suite will be allocated to a room with water birth facilities and have one-to-one care in labour by a midwife who is credentialed to conduct water births in accordance with evidence-informed guidelines. Women may access water immersion in labour and in the absence of an indication to exit the pool; the woman will proceed to give birth under water.
Intervention code [1] 295019 0
Not applicable
Comparator / control treatment
Participants who intend to have a land birth on admission to birth suite will be allocated to a room with access to a bath for water immersion but no facilities for water birth. Women will have one-to-one care in labour by a midwife credentialed in water immersion and may use water immersion in the first stage of labour if they wish. Women who use the bath will be asked to exit the bath at the onset of second stage labour and give birth to their babies 'on land' in a position of their choice.
Control group
Active

Outcomes
Primary outcome [1] 298608 0
Number and proportion of women who are: 1) potentially eligible / ineligible 2) recruited / not recruited [two outcomes]
Timepoint [1] 298608 0
On completion of recruitment by extraction from study's database and hospital's electronic perinatal database
Primary outcome [2] 298609 0
Of women who are eligible on admission to birth suite; the number of women who intend to water birth and do not intend to water birth
Timepoint [2] 298609 0
On admission to birth suite by extraction from the hospital's electronic perinatal database
Primary outcome [3] 298610 0
Of women who are eligible at onset of second stage labour; the number of women who intend to water birth and do not intend to water birth
Timepoint [3] 298610 0
At onset of second stage labour by extraction from the hospital's electronic perinatal database
Secondary outcome [1] 324716 0
Maternal baseline characteristics: age, ethnicity, level of education, gravida and parity, feeding intention at booking, medical history, body mass index (BMI), smoking status, Edinburgh Depression Score (EDS), Haemoglobin [ten separate outcomes].
Timepoint [1] 324716 0
Collected at hospital booking visit for the index pregnancy by extraction from hospital's electronic perinatal database
Secondary outcome [2] 324717 0
Augmentation of labour (ARM and/or oxytocic administration)(yes/no)
Timepoint [2] 324717 0
On completion of birth episode by extraction from hospital's electronic perinatal database
Secondary outcome [3] 324718 0
Non-pharmacological analgesia (yes/no); Pharmacological analgesia (including nitrous oxide, narcotic analgesia, regional analgesia, general analgesia) (yes/no for each of these outcomes) [five separate outcomes]
Timepoint [3] 324718 0
During a first or second stage of labour by extraction from hospital's perinatal database
Secondary outcome [4] 324720 0
Duration of each stage of labour (minutes)
Timepoint [4] 324720 0
On completion of birth episode by extraction from hospital's electronic perinatal database
Secondary outcome [5] 324722 0
Mode of birth (non-instrumental vaginal birth / instrumental vaginal birth / caesarean section)
Timepoint [5] 324722 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [6] 324723 0
Water birth (planned / unplanned / head only born underwater) [primary outcome]
Timepoint [6] 324723 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [7] 324724 0
The highest maternal temperature in labour (degrees Celsius)
Timepoint [7] 324724 0
During first or second stage of labour by extraction from hospital's perinatal database
Secondary outcome [8] 324725 0
Maternal collapse requiring resuscitation (yes/no)
Timepoint [8] 324725 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [9] 324726 0
Mother treated with antibiotics (yes / no)
Timepoint [9] 324726 0
During labour or prior to postnatal hospital discharge by extraction from hospital's perinatal database
Secondary outcome [10] 324727 0
Perineal status (intact, 1st, 2nd, 3rd, or 4th degree tears, episiotomy)
Timepoint [10] 324727 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [11] 324728 0
Management of third stage labour (active/physiological)
Timepoint [11] 324728 0
On completion of third stage labour by extraction from hospital's perinatal database
Secondary outcome [12] 324729 0
Estimated blood loss in the immediate postpartum period (millilitres); Major postpartum haemorrhage >1500mL and/or requiring operative procedure and/or maternal blood transfusion (yes / no); Maternal blood transfusion of three or more units of blood (yes/no) [three separate outcomes]
Timepoint [12] 324729 0
During labour or prior to postnatal hospital discharge by extraction from hospital's perinatal database
Secondary outcome [13] 324732 0
Maternal admission to intensive-care unit/high dependency unit (yes/no)
Timepoint [13] 324732 0
On completion of birth episode by extraction from hospital's electronic perinatal database
Secondary outcome [14] 324733 0
Length of stay in hospital for mothers following birth (days)
Timepoint [14] 324733 0
On postnatal discharge from hospital by extraction from hospital's patient management (iPM) database
Secondary outcome [15] 324734 0
Maternal readmission to hospital (yes/no)
Timepoint [15] 324734 0
Following discharge from hospital and within 6 weeks of giving birth by extraction from hospital's electronic perinatal database
Secondary outcome [16] 324735 0
Maternal death
Timepoint [16] 324735 0
During labour or within 6 weeks of giving birth by extraction from hospital's patient management (iPM) database
Secondary outcome [17] 324736 0
Perinatal death (stillbirth or neonatal death excluding lethal congenital anomalies)(yes/no)
Timepoint [17] 324736 0
During labour or prior to discharge from hospital by extraction from the hospital's electronic perinatal database
Secondary outcome [18] 324737 0
Birth weight (grams)
Timepoint [18] 324737 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [19] 324738 0
Gestational age at birth (weeks)
Timepoint [19] 324738 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [20] 324739 0
Intrapartum abnormal heart rate pattern (yes/no)
Timepoint [20] 324739 0
During first or second stage labour by extraction from hospital's perinatal database
Secondary outcome [21] 324740 0
Meconium-stained liquor (yes/no)
Timepoint [21] 324740 0
At any time following rupture of membranes until birth of the baby by extraction from hospital's perinatal database
Secondary outcome [22] 324741 0
Positive pressure ventilation (yes/no)
Timepoint [22] 324741 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [23] 324742 0
Snapped cord during birth (yes / no)
Timepoint [23] 324742 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [24] 324743 0
Neonatal blood transfusion (yes/no)
Timepoint [24] 324743 0
At any point following birth and prior to hospital discharge by extraction from hospital's neonatal database
Secondary outcome [25] 324744 0
Cord pH <7.00 and/or base deficit <-10 (arterial cord blood) (yes/no)
Timepoint [25] 324744 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [26] 324745 0
Resuscitation which includes intubation for ventilation, cardiac massage and/or the administration of drugs of resuscitation (e.g. Adrenaline, Sodium Bicarbonate, Fluids) (yes/no)
Timepoint [26] 324745 0
On completion of birth episode by extraction from hospital's perinatal database
Secondary outcome [27] 324746 0
Apgar score < 7 at 5 minutes (yes/no) ; Apgar score < 4 at 5 minutes (yes/no) [two outcomes]
Timepoint [27] 324746 0
Five minutes after birth by extraction from hospital's electronic perinatal database
Secondary outcome [28] 324748 0
Admitted to a neonatal nursery (yes/no); Admitted to a neonatal intensive care unit (NICU) (yes/no) [two outcomes]
Timepoint [28] 324748 0
On completion of birth episode by extraction from hospital's electronic perinatal database
Secondary outcome [29] 324750 0
Admitted to a special care or NICU for > 4 days (yes/no)
Timepoint [29] 324750 0
On discharge from hospital by extraction from hospital's patient management (iPM)database
Secondary outcome [30] 324751 0
Length of stay in neonatal nursery (days)
Timepoint [30] 324751 0
On discharge from neonatal nursery by extraction from hospital's patient management (iPM) database
Secondary outcome [31] 324752 0
Length of neonatal hospital stay (days)
Timepoint [31] 324752 0
On discharge from hospital by extraction from hospital's patient management (iPM) database
Secondary outcome [32] 324753 0
Neonatal readmission to hospital (yes/no)
Timepoint [32] 324753 0
Any time from hospital discharge until 28 days of age from hospital's patient management (iPM) database
Secondary outcome [33] 324754 0
Any type of birth injury (recorded by diagnosis)
Timepoint [33] 324754 0
On completion of birth episode by extraction from hospital's electronic perinatal database
Secondary outcome [34] 324755 0
Serious neonatal adverse event - composite outcome: stillbirth/fetal death in labour after study entry; death of a live born infant before discharge from hospital; resuscitation, which includes intubation for ventilation, cardiac massage and/or the administration of drugs of resuscitation (e.g. Adrenaline, Sodium Bicarbonate, Fluids); hypoxic Ischemic Encephalopathy (HIE) 2 or 3; seizures under 48 hours; Apgar score < 4 at 5 minutes; admission to NICU > 4 days (96 hours); proven systemic infection in first 48 hours of life (treated with antibiotics)
Timepoint [34] 324755 0
Prior to discharge from hospital by extraction from hospital's electronic neonatal database
Secondary outcome [35] 324758 0
Breastfeeding initiation at birth (yes/no)
Timepoint [35] 324758 0
On completion of birth episode by extraction from hospital's electronic perinatal database
Secondary outcome [36] 324759 0
Infant feeding at hospital discharge (breastfeeding/formula/breast and formula/breast and expressed breast milk/expressed milk/gavage/not applicable)
Timepoint [36] 324759 0
On postnatal discharge from hospital by extraction from hospital's electronic perinatal database
Secondary outcome [37] 324760 0
Neonatal temperature at birth (degrees Celsius)
Timepoint [37] 324760 0
On completion of birth episode by extraction from hospital's electronic perinatal database
Secondary outcome [38] 324761 0
Pain during labour and birth, satisfaction with birth experience, water birth intention, reasons for not having a water birth, experiences of water birth, neonatal health problems including re-admission to hospital [six outcomes]
Timepoint [38] 324761 0
At 6 weeks postpartum by survey using 10-point numerical rating scales, 4-point Likert scales, categorical and free-text responses
Secondary outcome [39] 324880 0
Staff baseline characteristics, knowledge, attitudes, experiences and satisfaction with caring for women planning a water birth [five outcomes]
Timepoint [39] 324880 0
By electronic survey using 5-point Likert scales, categorical and free-text responses during data collection

Eligibility
Key inclusion criteria
- 15 years or older
- do not require interpreter
- weigh less than 100 kilograms
- low obstetric risk
- suitable for intermittent auscultation in labour
- singleton viable pregnancy
- admitted to birth suite in spontaneous labour at term
- vertex presentation
- intact membranes or draining clear liquor (PROM <24 hours)
- maternal and fetal observations within normal limits
- vaginal bleeding within normal limits (i.e. no more than a 'show')
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 14 years or younger
- require an interpreter or legal guardian for consent
- weigh 100 kilograms or more
- obstetric risk factors
- not suitable for intermittent auscultation in labour
- multiple pregnancy or fetal demise
- blood born infection e.g. Hepatitis B, C and HIV
- major congenital anomalies
- admitted to birth suite in labour <37+0 or >42 weeks' gestation
- induction or planned caesarean
- non-vertex presentation
- meconium-stained liquor
- abnormal maternal or fetal observations
- any suspected or proven active infectious illness
- requesting narcotic or epidural analgesia
- any contraindication to intermittent fetal heart rate monitoring
- vaginal bleeding more than 'show'

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Feasibility outcomes
Simple descriptive statistics will be used to analyse the feasibility outcomes. Interim reporting of recruitment data will occur monthly. It will be considered feasible to conduct the main study if at least 25% of eligible women are recruited, and at least 50% of women who intend to water birth proceed to give birth under water.

Clinical outcomes
Clinical outcome data will be analysed using StataSE (Version 12) software. Basic descriptive statistics with confidence intervals with be calculated and reported as this feasibility study is not powered for any clinical outcomes.

Survey data
Survey data will be analysed using univariate statistics in StataSE (Version 12) software. Descriptive statistics will be calculated for all variables, including mean, median, standard deviation, range, and percentages as appropriate. Categorical data will be analysed using Chi square. Thematic analysis of free text responses will also be conducted. The response rate will also be calculated and reported.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
2/10/2014
Date of last participant enrolment
Anticipated
1/10/2016
Actual
Date of last data collection
Anticipated
31/12/2016
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5965 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 13387 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 293805 0
Hospital
Name [1] 293805 0
Mater Mother's Hospital
Country [1] 293805 0
Australia
Funding source category [2] 294107 0
University
Name [2] 294107 0
Western Sydney University
Country [2] 294107 0
Australia
Funding source category [3] 294109 0
Charities/Societies/Foundations
Name [3] 294109 0
Mater Foundation
Country [3] 294109 0
Australia
Funding source category [4] 294112 0
University
Name [4] 294112 0
University of Queensland
Country [4] 294112 0
Australia
Primary sponsor type
Individual
Name
Professor Sue Kildea
Address
Level 1, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
Country
Australia
Secondary sponsor category [1] 292637 0
Hospital
Name [1] 292637 0
Mater Mother's Hospital
Address [1] 292637 0
Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
Country [1] 292637 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295237 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 295237 0
Level 2, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
Ethics committee country [1] 295237 0
Australia
Date submitted for ethics approval [1] 295237 0
22/11/2013
Approval date [1] 295237 0
20/03/2014
Ethics approval number [1] 295237 0
HREC/13/MHS/176
Ethics committee name [2] 295238 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 295238 0
Cumbrae Stewart Building, Research Road, University of Queensland, St Lucia, Queensland, 4072
Ethics committee country [2] 295238 0
Australia
Date submitted for ethics approval [2] 295238 0
Approval date [2] 295238 0
06/08/2014
Ethics approval number [2] 295238 0
2014001040

Summary
Brief summary
Water birth occurs when a baby is born fully submerged in water. There is a lack of strong (Level 1) evidence to conclusively agree on the safety or risk of water birth. We aim to determine if it is possible to run a large study that examines the safety of water birth compared to land birth in women with low-risk pregnancies. In this study, we will test recruitment parameters, research processes, and outcome measures (for mother and baby) to assess the feasibility of a main study. If this study proves feasible and funding is obtained, then we will consider an international study across multiple sites (subject to ethical approval) with the primary purpose of testing safety for babies who are born under water.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66646 0
Prof Sue Kildea
Address 66646 0
Level 1, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 410 1
Country 66646 0
Australia
Phone 66646 0
+61731636388
Fax 66646 0
Email 66646 0
[email protected]
Contact person for public queries
Name 66647 0
Ms Lucinda Whybrow
Address 66647 0
Level 2, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
Country 66647 0
Australia
Phone 66647 0
+61731636342
Fax 66647 0
Email 66647 0
[email protected]
Contact person for scientific queries
Name 66648 0
Prof Sue Kildea
Address 66648 0
Level 1, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
Country 66648 0
Australia
Phone 66648 0
+61731636388
Fax 66648 0
Email 66648 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseIs a randomized controlled trial of waterbirth possible? An Australian feasibility study.2022https://dx.doi.org/10.1111/birt.12635
N.B. These documents automatically identified may not have been verified by the study sponsor.