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Trial of Underwater Birth

Trial of Underwater Birth: A Randomized Control Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07313319
Acronym
TUB
Enrollment
230
Registered
2025-12-31
Start date
2026-04-21
Completion date
2028-12-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth

Keywords

waterbirth, landbirth, epidural use, birth outcomes

Brief summary

Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.

Detailed description

The proposed randomized control trial will be approached as a pilot study to explore or test (if sample size permits) our hypotheses. Primary outcome: Use of epidural anesthesia during labor and vaginal birth. Secondary outcomes: Use of IV narcotics in labor, duration of active labor, mode of delivery, composite maternal adverse outcomes (see below), use of intermittent auscultation (IA), composite neonatal adverse outcomes (see below), United States Birth Satisfaction Scale-Revised (US-BSS-R), use of epidural analgesia during labor (full intention-to-treat analysis).

Interventions

PROCEDUREWaterbirth

Those who remain eligible will have an inflatable birthing tub set up in their room and available for them to use as desired. Waterbirth will be performed in adherence to the following protocol endorsed by the American College of Nurse Midwives.

Sponsors

University of New Mexico
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria based on A model practice template for hydrotherapy in labor and birth (2016): Prenatal inclusion criteria (to be assessed at the time of enrollment): * ≥18 years of age * Able to speak and understand English or Spanish * Singleton gestation * Vertex presentation * Able to ambulate with no mobility restrictions (i.e., no difficulty getting from seated to standing) * Less than class III obesity (BMI \<40 kg/m2) at initiation of prenatal care Labor inclusion criteria (to be assessed at time of admission): * Greater than 37 weeks 0 days through and less than 412 completed weeks 6 days gestation with fetus in vertex presentation * Normal blood pressure and normal temperature (obstetric criteria for exclusion: two blood pressures 140/90 four hours apart; two fevers of over 100.4 one hour apart)

Exclusion criteria

based on A model practice template for hydrotherapy in labor and birth (2016): Prenatal

Design outcomes

Primary

MeasureTime frameDescription
Epidural AnesthesiaLabor and deliveryEvaluate the epidural anesthesia rate in adult low-risk laboring people randomized to have the option of waterbirth compared to those randomized to birth on land.

Secondary

MeasureTime frameDescription
IV Narcotic UseLabor and deliveryUse of IV narcotics in labor
Active Labor DurationLabor and deliveryduration of active labor
Delivery ModeLabor and deliveryMode of delivery
Maternal Adverse OutcomesUp to 2 weeks postpartumComposite maternal adverse outcomes
Intermittent Auscultation (IA)Labor and deliveryUse of intermittent auscultation (IA)
Neonatal Adverse OutcomesUp to 2 weeks postpartumComposite neonatal adverse outcomes
United States Birth Satisfaction Scale-Revised (US-BSS-R)3 days to 2 weeks postpartumSatisfaction with birth experience

Countries

United States

Contacts

CONTACTFamily Planning Research
FamilyPlanningResearch@salud.unm.edu505-205-4118
PRINCIPAL_INVESTIGATORKatrina Nardini

University of New Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026