BirthTUBNCT07313319
Trial of Underwater Birth
A study testing Waterbirth in people with Birth, run by University of New Mexico at 1 site in United States.
Trial summary
Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Birth
- What is being tested?
- Waterbirth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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 exclusion criteria (to be assessed at the time of enrollment):
- Active infections such as HIV, Hepatitis B, Hepatitis C, HSV outbreak (on prophylaxis acceptable) (GBS positive is acceptable)
- Pre-existing medical conditions including heart disease, uncontrolled asthma, preexisting diabetes, chronic hypertension, or activity restrictions
- High-risk pregnancy conditions including preeclampsia, gestational hypertension, preterm gestation, multiple gestation, gestational diabetes type A2, estimated fetal weight of 5000g for non-diabetics or >4500 for GDM-A1, unstable substance use disorder (i.e. not in remission), placental abruption or other unexplained vaginal bleeding, previous cesarean section, fetal growth restriction (<10th percentile), fetal anomaly, or other neonatal condition that may complicate neonatal transition to extrauterine life.
- Existing contraindication to vaginal birth
Labor exclusion criteria (to be assessed at the time of admission):
- Meconium-stained amniotic fluid
- Preterm rupture of membranes (PROM) greater than 24 hours without the start of any labor contractions (those whose have PROM greater than 24 hours but are in labor can continue to be included in the study)
- Immediate need for operative delivery at time of admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87131
Family Planning Research, 505-205-4118, hsc-familyplanningresearch@salud.unm.edu
About this study
Official title: Trial of Underwater Birth: A Randomized Control Trial
Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.
Read the 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).
- Conditions
- Birth
- Being tested
- Waterbirth
- Keywords
- waterbirth, landbirth, epidural use, birth outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterbirthProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Land Birth | No intervention | Study subjects enrolled in the land birth cohort of this study will receive care as usual on labor and delivery. There will be no changes to their intrapartum care including their ability to use water as a form of pain relief during labor (Stage 1 water immersion) if deemed appropriate by their care team. Land birth participants who use water for pain relief will be assisted out of the water prior to second stage (pushing) as is currently routine on UNMH Labor and Delivery. |
| Waterbirth | Experimental | Subjects enrolled in the waterbirth cohort will be assessed for continued eligibility at time of admission to labor and delivery and continuously during labor. 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. Receives: Procedure: Waterbirth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidural Anesthesia
Evaluate 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.
Measured: Labor and delivery
Secondary outcomes (7)
IV Narcotic Use
Use of IV narcotics in labor
Measured: Labor and delivery
Active Labor Duration
duration of active labor
Measured: Labor and delivery
Delivery Mode
Mode of delivery
Measured: Labor and delivery
Maternal Adverse Outcomes
Composite maternal adverse outcomes
Measured: Up to 2 weeks postpartum
Intermittent Auscultation (IA)
Use of intermittent auscultation (IA)
Measured: Labor and delivery
Neonatal Adverse Outcomes
Composite neonatal adverse outcomes
Measured: Up to 2 weeks postpartum
United States Birth Satisfaction Scale-Revised (US-BSS-R)
Satisfaction with birth experience
Measured: 3 days to 2 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start21 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrina Nardini, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313319
- Sponsor's protocol ID
- 25-454
- Other IDs
- Lacks Grant
- Acronym
- TUB
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Underwater Birth: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07313319
- Acronym / sponsor ID
- TUB / 25-454
- Conditions
- Birth
- Keywords
- waterbirth, landbirth, epidural use, birth outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Land Birth | No intervention | –Study subjects enrolled in the land birth cohort of this study will receive care as usual on labor and delivery. There will be no changes to their intrapartum care including their ability to use water as a form of pain relief during labor (Stage 1 water immersion) if deemed appropriate by their care team. Land birth participants who use water for pain relief will be assisted out of the water prior to second stage (pushing) as is currently routine on UNMH Labor and Delivery. |
| Waterbirth | Experimental | Procedure: WaterbirthSubjects enrolled in the waterbirth cohort will be assessed for continued eligibility at time of admission to labor and delivery and continuously during labor. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterbirthThose 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. | Procedure or surgery | Waterbirth |
Primary outcome
Epidural Anesthesia
Time frame: Labor and delivery
Evaluate 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.
7 secondary outcomes
IV Narcotic Use
Time frame: Labor and delivery
Active Labor Duration
Time frame: Labor and delivery
Delivery Mode
Time frame: Labor and delivery
Maternal Adverse Outcomes
Time frame: Up to 2 weeks postpartum
Intermittent Auscultation (IA)
Time frame: Labor and delivery
Neonatal Adverse Outcomes
Time frame: Up to 2 weeks postpartum
United States Birth Satisfaction Scale-Revised (US-BSS-R)
Time frame: 3 days to 2 weeks postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katrina Nardini principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Waterbirth in people with Birth, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Family Planning Research (505-205-4118, FamilyPlanningResearch@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidural Anesthesia (time frame: Labor and delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.