Trial Outcomes & Findings for Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes (NCT NCT05175599)
NCT ID: NCT05175599
Last Updated: 2026-05-05
Results Overview
The number of women in the waterbirth cohort who use IV narcotic and epidural anesthesia compared with the land birth cohort.
COMPLETED
NA
186 participants
Time of admission to birth of the baby
2026-05-05
Participant Flow
IRB-approved recruitment flyers were placed in clinic lobbies to increase interest during prenatal care visits. During prenatal care visits between 25-34 weeks' gestation, pregnant people who met inclusion criterial were offered voluntary participation after informed consent.
Upon enrollment, participants were randomized to either the waterbirth group or land birth group using a computer-generated allocation sequence. When participants presented to the labor and delivery until, both groups were reassessed for eligibility. If they remained eligible, those in the waterbirth group received routine care, all available pain relief options, with the additional option of giving birth in the water. Land birth were not given option of birth in the water.
Participant milestones
| Measure |
Land Birth
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
124
|
|
Overall Study
COMPLETED
|
32
|
74
|
|
Overall Study
NOT COMPLETED
|
30
|
50
|
Reasons for withdrawal
| Measure |
Land Birth
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Overall Study
No longer eligible for Waterbirth
|
30
|
50
|
Baseline Characteristics
Numbers based on those who remained eligible at time of delivery.
Baseline characteristics by cohort
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.5 years
n=54 Participants • Numbers based on those who remained eligible at time of delivery.
|
30.1 years
n=60 Participants • Numbers based on those who remained eligible at time of delivery.
|
28.8 years
n=114 Participants • Numbers based on those who remained eligible at time of delivery.
|
|
Sex: Female, Male
Female
|
32 Participants
n=54 Participants • Only people born of female sex were enrolled. Numbers based on those who remained eligible at time of delivery.
|
74 Participants
n=60 Participants • Only people born of female sex were enrolled. Numbers based on those who remained eligible at time of delivery.
|
106 Participants
n=114 Participants • Only people born of female sex were enrolled. Numbers based on those who remained eligible at time of delivery.
|
|
Sex: Female, Male
Male
|
0 Participants
n=54 Participants • Only people born of female sex were enrolled. Numbers based on those who remained eligible at time of delivery.
|
0 Participants
n=60 Participants • Only people born of female sex were enrolled. Numbers based on those who remained eligible at time of delivery.
|
0 Participants
n=114 Participants • Only people born of female sex were enrolled. Numbers based on those who remained eligible at time of delivery.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black
|
11 Participants
n=54 Participants
|
21 Participants
n=60 Participants
|
32 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
3 Participants
n=54 Participants
|
10 Participants
n=60 Participants
|
13 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
1 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
17 Participants
n=54 Participants
|
37 Participants
n=60 Participants
|
54 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Time of admission to birth of the babyPopulation: Numbers based on those who remained eligible at time of delivery.
The number of women in the waterbirth cohort who use IV narcotic and epidural anesthesia compared with the land birth cohort.
Outcome measures
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Number of Women Using Intravenous Narcotic Analgesia and Epidural Anesthesia
|
26 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Time of labor onset to time of birthPopulation: Numbers based on those who remained eligible at time of delivery.
The median time of labor duration (1st stage onset of strong regular contractions resulting in cervical change, 2nd stage pushing and birth of the neonate, 3rd stage delivery of the placenta) of women in the waterbirth cohort will be compared to the land birth cohort.
Outcome measures
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Median Time of Labor Duration
First stage labor duration (minutes)
|
480.0 Minutes
Interval 300.0 to 720.0
|
360.0 Minutes
Interval 240.0 to 660.0
|
|
Median Time of Labor Duration
Second stage duration (minutes)
|
26.0 Minutes
Interval 16.0 to 63.0
|
26.0 Minutes
Interval 8.0 to 78.0
|
|
Median Time of Labor Duration
Third stage duration (minutes)
|
9.0 Minutes
Interval 6.0 to 13.0
|
12.0 Minutes
Interval 8.0 to 19.0
|
SECONDARY outcome
Timeframe: Up to 72 hours post deliveryPopulation: Numbers based on those who remained eligible at time of delivery.
The US-BSS-R is a 10 question scale using a 5 point Likert scale with answers ranging from "strongly agree" to "strongly disagree". The overall US-BSS-R total birth satisfaction score ranging from 0-40 (least birth satisfaction - most birth satisfaction). Women in the waterbirth cohort will be compared to those in the land birth cohort for overall US-BSS-R score.
Outcome measures
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
United States Birth Satisfaction Scale-Revised (US-BSS-R) Score
|
33.00 Score
Interval 32.0 to 33.0
|
29.50 Score
Interval 28.0 to 32.0
|
SECONDARY outcome
Timeframe: During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)The number of women in the waterbirth cohort with reported adverse maternal obstetric outcomes will be compared to the land birth cohort.
Outcome measures
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Number of Reported Maternal Adverse Outcomes
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Measured from birth (immediate) through discharge from hospital (24-48 hours)Population: Numbers based on those who remained eligible at time of delivery.
The number of women in the waterbirth cohort who initiate immediately after the birth breastfeeding will be compared to those in the land birth cohort.
Outcome measures
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Number of Patients Breastfeeding
|
30 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life)The number of patients with neonates in the waterbirth cohort with reported adverse birth outcomes will be compared to patients with neonates in the land birth cohort.
Outcome measures
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Number of Neonatal Adverse Outcomes
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Time of labor to time of deliveryThe number of patients with neonates in the waterbirth cohort with instrumental and cesarean deliveries will be compared to patients with neonates in the land birth cohort.
Outcome measures
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Number of Patients With Neonates With Instrumental and Cesarean Deliveries
Instrumental delivery
|
1 Participants
|
3 Participants
|
|
Number of Patients With Neonates With Instrumental and Cesarean Deliveries
Cesarean delivery
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Measured from time of birth (hour/minute) to time of skin-to-skin contact initiation (in number of minutes) up to 60 minutes of life.The number of patients with neonates in the waterbirth cohort with skin-to-skin contact will be compared with patients with neonates in the land birth cohort.
Outcome measures
| Measure |
Land Birth
n=32 Participants
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=74 Participants
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Number of Patients With Skin-to-skin Contact
|
27 Participants
|
68 Participants
|
Adverse Events
Land Birth
Water Birth
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Land Birth
n=62 participants at risk
Women in the land birth group will labor and give birth according to standard of care procedures.
|
Water Birth
n=124 participants at risk
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Composite adverse neonatal outcomes before discharge
|
4.8%
3/62 • Number of events 5 • From time of enrollment up to 8 weeks post delivery
|
4.8%
6/124 • Number of events 10 • From time of enrollment up to 8 weeks post delivery
|
|
Pregnancy, puerperium and perinatal conditions
Composite adverse neonatal outcomes following discharge
|
1.6%
1/62 • Number of events 1 • From time of enrollment up to 8 weeks post delivery
|
1.6%
2/124 • Number of events 4 • From time of enrollment up to 8 weeks post delivery
|
|
Pregnancy, puerperium and perinatal conditions
Composite adverse maternal outcomes before discharge
|
3.2%
2/62 • Number of events 3 • From time of enrollment up to 8 weeks post delivery
|
5.6%
7/124 • Number of events 7 • From time of enrollment up to 8 weeks post delivery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place