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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
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Scientific title
Water birth Access at Term to Estimate Risks and Benefits In Research cohorTs in Hospital (WATERBIRTH): prospective cohort feasibility study
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Secondary ID [1]
289429
0
Nil known
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Universal Trial Number (UTN)
U1111-1184-2421
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Trial acronym
WATERBIRTH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Waterbirth
299108
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Condition category
Condition code
Reproductive Health and Childbirth
299134
299134
0
0
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Childbirth and postnatal care
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
6
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Target follow-up type
Weeks
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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.
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Intervention code [1]
295019
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Not applicable
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
298608
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Number and proportion of women who are: 1) potentially eligible / ineligible 2) recruited / not recruited [two outcomes]
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Assessment method [1]
298608
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Timepoint [1]
298608
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On completion of recruitment by extraction from study's database and hospital's electronic perinatal database
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Primary outcome [2]
298609
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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
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Assessment method [2]
298609
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Timepoint [2]
298609
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On admission to birth suite by extraction from the hospital's electronic perinatal database
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Primary outcome [3]
298610
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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
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Assessment method [3]
298610
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Timepoint [3]
298610
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At onset of second stage labour by extraction from the hospital's electronic perinatal database
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Secondary outcome [1]
324716
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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].
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Assessment method [1]
324716
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Timepoint [1]
324716
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Collected at hospital booking visit for the index pregnancy by extraction from hospital's electronic perinatal database
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Secondary outcome [2]
324717
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Augmentation of labour (ARM and/or oxytocic administration)(yes/no)
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Assessment method [2]
324717
0
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Timepoint [2]
324717
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On completion of birth episode by extraction from hospital's electronic perinatal database
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Secondary outcome [3]
324718
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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]
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Assessment method [3]
324718
0
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Timepoint [3]
324718
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During a first or second stage of labour by extraction from hospital's perinatal database
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Secondary outcome [4]
324720
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Duration of each stage of labour (minutes)
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Assessment method [4]
324720
0
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Timepoint [4]
324720
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On completion of birth episode by extraction from hospital's electronic perinatal database
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Secondary outcome [5]
324722
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Mode of birth (non-instrumental vaginal birth / instrumental vaginal birth / caesarean section)
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Assessment method [5]
324722
0
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Timepoint [5]
324722
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On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [6]
324723
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Water birth (planned / unplanned / head only born underwater) [primary outcome]
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Assessment method [6]
324723
0
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Timepoint [6]
324723
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On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [7]
324724
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The highest maternal temperature in labour (degrees Celsius)
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Assessment method [7]
324724
0
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Timepoint [7]
324724
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During first or second stage of labour by extraction from hospital's perinatal database
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Secondary outcome [8]
324725
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Maternal collapse requiring resuscitation (yes/no)
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Assessment method [8]
324725
0
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Timepoint [8]
324725
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On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [9]
324726
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Mother treated with antibiotics (yes / no)
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Assessment method [9]
324726
0
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Timepoint [9]
324726
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During labour or prior to postnatal hospital discharge by extraction from hospital's perinatal database
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Secondary outcome [10]
324727
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Perineal status (intact, 1st, 2nd, 3rd, or 4th degree tears, episiotomy)
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Assessment method [10]
324727
0
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Timepoint [10]
324727
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On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [11]
324728
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Management of third stage labour (active/physiological)
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Assessment method [11]
324728
0
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Timepoint [11]
324728
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On completion of third stage labour by extraction from hospital's perinatal database
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Secondary outcome [12]
324729
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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]
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Assessment method [12]
324729
0
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Timepoint [12]
324729
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During labour or prior to postnatal hospital discharge by extraction from hospital's perinatal database
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Secondary outcome [13]
324732
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Maternal admission to intensive-care unit/high dependency unit (yes/no)
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Assessment method [13]
324732
0
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Timepoint [13]
324732
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On completion of birth episode by extraction from hospital's electronic perinatal database
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Secondary outcome [14]
324733
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Length of stay in hospital for mothers following birth (days)
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Assessment method [14]
324733
0
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Timepoint [14]
324733
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On postnatal discharge from hospital by extraction from hospital's patient management (iPM) database
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Secondary outcome [15]
324734
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Maternal readmission to hospital (yes/no)
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Assessment method [15]
324734
0
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Timepoint [15]
324734
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Following discharge from hospital and within 6 weeks of giving birth by extraction from hospital's electronic perinatal database
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Secondary outcome [16]
324735
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Maternal death
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Assessment method [16]
324735
0
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Timepoint [16]
324735
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During labour or within 6 weeks of giving birth by extraction from hospital's patient management (iPM) database
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Secondary outcome [17]
324736
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Perinatal death (stillbirth or neonatal death excluding lethal congenital anomalies)(yes/no)
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Assessment method [17]
324736
0
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Timepoint [17]
324736
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During labour or prior to discharge from hospital by extraction from the hospital's electronic perinatal database
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Secondary outcome [18]
324737
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Birth weight (grams)
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Assessment method [18]
324737
0
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Timepoint [18]
324737
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On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [19]
324738
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Gestational age at birth (weeks)
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Assessment method [19]
324738
0
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Timepoint [19]
324738
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On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [20]
324739
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Intrapartum abnormal heart rate pattern (yes/no)
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Assessment method [20]
324739
0
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Timepoint [20]
324739
0
During first or second stage labour by extraction from hospital's perinatal database
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Secondary outcome [21]
324740
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Meconium-stained liquor (yes/no)
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Assessment method [21]
324740
0
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Timepoint [21]
324740
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At any time following rupture of membranes until birth of the baby by extraction from hospital's perinatal database
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Secondary outcome [22]
324741
0
Positive pressure ventilation (yes/no)
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Assessment method [22]
324741
0
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Timepoint [22]
324741
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On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [23]
324742
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Snapped cord during birth (yes / no)
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Assessment method [23]
324742
0
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Timepoint [23]
324742
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On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [24]
324743
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Neonatal blood transfusion (yes/no)
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Assessment method [24]
324743
0
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Timepoint [24]
324743
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At any point following birth and prior to hospital discharge by extraction from hospital's neonatal database
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Secondary outcome [25]
324744
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Cord pH <7.00 and/or base deficit <-10 (arterial cord blood) (yes/no)
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Assessment method [25]
324744
0
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Timepoint [25]
324744
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On completion of birth episode by extraction from hospital's perinatal database
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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)
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Assessment method [26]
324745
0
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Timepoint [26]
324745
0
On completion of birth episode by extraction from hospital's perinatal database
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Secondary outcome [27]
324746
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Apgar score < 7 at 5 minutes (yes/no) ; Apgar score < 4 at 5 minutes (yes/no) [two outcomes]
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Assessment method [27]
324746
0
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Timepoint [27]
324746
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Five minutes after birth by extraction from hospital's electronic perinatal database
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Secondary outcome [28]
324748
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Admitted to a neonatal nursery (yes/no); Admitted to a neonatal intensive care unit (NICU) (yes/no) [two outcomes]
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Assessment method [28]
324748
0
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Timepoint [28]
324748
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On completion of birth episode by extraction from hospital's electronic perinatal database
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Secondary outcome [29]
324750
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Admitted to a special care or NICU for > 4 days (yes/no)
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Assessment method [29]
324750
0
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Timepoint [29]
324750
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On discharge from hospital by extraction from hospital's patient management (iPM)database
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Secondary outcome [30]
324751
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Length of stay in neonatal nursery (days)
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Assessment method [30]
324751
0
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Timepoint [30]
324751
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On discharge from neonatal nursery by extraction from hospital's patient management (iPM) database
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Secondary outcome [31]
324752
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Length of neonatal hospital stay (days)
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Assessment method [31]
324752
0
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Timepoint [31]
324752
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On discharge from hospital by extraction from hospital's patient management (iPM) database
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Secondary outcome [32]
324753
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Neonatal readmission to hospital (yes/no)
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Assessment method [32]
324753
0
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Timepoint [32]
324753
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Any time from hospital discharge until 28 days of age from hospital's patient management (iPM) database
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Secondary outcome [33]
324754
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Any type of birth injury (recorded by diagnosis)
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Assessment method [33]
324754
0
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Timepoint [33]
324754
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On completion of birth episode by extraction from hospital's electronic perinatal database
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Secondary outcome [34]
324755
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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)
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Assessment method [34]
324755
0
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Timepoint [34]
324755
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Prior to discharge from hospital by extraction from hospital's electronic neonatal database
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Secondary outcome [35]
324758
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Breastfeeding initiation at birth (yes/no)
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Assessment method [35]
324758
0
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Timepoint [35]
324758
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On completion of birth episode by extraction from hospital's electronic perinatal database
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Secondary outcome [36]
324759
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Infant feeding at hospital discharge (breastfeeding/formula/breast and formula/breast and expressed breast milk/expressed milk/gavage/not applicable)
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Assessment method [36]
324759
0
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Timepoint [36]
324759
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On postnatal discharge from hospital by extraction from hospital's electronic perinatal database
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Secondary outcome [37]
324760
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Neonatal temperature at birth (degrees Celsius)
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Assessment method [37]
324760
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Timepoint [37]
324760
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On completion of birth episode by extraction from hospital's electronic perinatal database
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Secondary outcome [38]
324761
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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]
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Assessment method [38]
324761
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Timepoint [38]
324761
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At 6 weeks postpartum by survey using 10-point numerical rating scales, 4-point Likert scales, categorical and free-text responses
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Secondary outcome [39]
324880
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Staff baseline characteristics, knowledge, attitudes, experiences and satisfaction with caring for women planning a water birth [five outcomes]
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Assessment method [39]
324880
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Timepoint [39]
324880
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By electronic survey using 5-point Likert scales, categorical and free-text responses during data collection
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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')
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
Yes
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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'
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
2/10/2014
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Date of last participant enrolment
Anticipated
1/10/2016
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Actual
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Date of last data collection
Anticipated
31/12/2016
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Actual
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Sample size
Target
600
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
5965
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Mater Mother's Hospital - South Brisbane
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Recruitment postcode(s) [1]
13387
0
4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
293805
0
Hospital
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Name [1]
293805
0
Mater Mother's Hospital
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Address [1]
293805
0
Level 2, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
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Country [1]
293805
0
Australia
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Funding source category [2]
294107
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University
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Name [2]
294107
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Western Sydney University
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Address [2]
294107
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School of Nursing and Midwifery, Western Sydney University, Locked Bag 1797, Penrith, New South Wales, 2751
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Country [2]
294107
0
Australia
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Funding source category [3]
294109
0
Charities/Societies/Foundations
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Name [3]
294109
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Mater Foundation
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Address [3]
294109
0
580 Stanley Street, South Brisbane, Queensland, 4101
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Country [3]
294109
0
Australia
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Funding source category [4]
294112
0
University
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Name [4]
294112
0
University of Queensland
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Address [4]
294112
0
School of Nursing, Midwifery and Social Work, Level 3, Chamberlain Building (Building 35), University of Queensland, St Lucia, Queensland, 4165
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Country [4]
294112
0
Australia
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Primary sponsor type
Individual
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Name
Professor Sue Kildea
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Address
Level 1, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
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Country
Australia
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Secondary sponsor category [1]
292637
0
Hospital
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Name [1]
292637
0
Mater Mother's Hospital
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Address [1]
292637
0
Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
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Country [1]
292637
0
Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
295237
0
Mater Health Services Human Research Ethics Committee
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Ethics committee address [1]
295237
0
Level 2, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
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Ethics committee country [1]
295237
0
Australia
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Date submitted for ethics approval [1]
295237
0
22/11/2013
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Approval date [1]
295237
0
20/03/2014
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Ethics approval number [1]
295237
0
HREC/13/MHS/176
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Ethics committee name [2]
295238
0
University of Queensland Human Research Ethics Committee
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Ethics committee address [2]
295238
0
Cumbrae Stewart Building, Research Road, University of Queensland, St Lucia, Queensland, 4072
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Ethics committee country [2]
295238
0
Australia
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Date submitted for ethics approval [2]
295238
0
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Approval date [2]
295238
0
06/08/2014
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Ethics approval number [2]
295238
0
2014001040
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
66646
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Prof Sue Kildea
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Address
66646
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Level 1, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 410 1
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Country
66646
0
Australia
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Phone
66646
0
+61731636388
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Fax
66646
0
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Email
66646
0
[email protected]
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Contact person for public queries
Name
66647
0
Lucinda Whybrow
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Address
66647
0
Level 2, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
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Country
66647
0
Australia
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Phone
66647
0
+61731636342
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Fax
66647
0
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Email
66647
0
[email protected]
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Contact person for scientific queries
Name
66648
0
Sue Kildea
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Address
66648
0
Level 1, Aubigny Place, Mater Health Services, Raymond Terrace, South Brisbane, Queensland, 4101
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Country
66648
0
Australia
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Phone
66648
0
+61731636388
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Fax
66648
0
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Email
66648
0
[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Is a randomized controlled trial of waterbirth possible? An Australian feasibility study.
2022
https://dx.doi.org/10.1111/birt.12635
N.B. These documents automatically identified may not have been verified by the study sponsor.
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