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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Family Planning Research contact

505-205-4118

FamilyPlanningResearch@salud.unm.edu

United States1 site, 1 recruiting
  • University of New Mexico

    Albuquerque, New Mexico, 87131

    Family Planning Research, 505-205-4118, hsc-familyplanningresearch@salud.unm.edu

    Recruiting

Other trials in United States

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 groups in NCT07313319
Study groupRoleWhat they receive
Land BirthNo interventionStudy 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.
WaterbirthExperimentalSubjects 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.

  1. 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)
  1. IV Narcotic Use

    Use of IV narcotics in labor

    Measured: Labor and delivery

  2. Active Labor Duration

    duration of active labor

    Measured: Labor and delivery

  3. Delivery Mode

    Mode of delivery

    Measured: Labor and delivery

  4. Maternal Adverse Outcomes

    Composite maternal adverse outcomes

    Measured: Up to 2 weeks postpartum

  5. Intermittent Auscultation (IA)

    Use of intermittent auscultation (IA)

    Measured: Labor and delivery

  6. Neonatal Adverse Outcomes

    Composite neonatal adverse outcomes

    Measured: Up to 2 weeks postpartum

  7. 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.

  1. First posted31 Dec 2025
  2. Study start21 Apr 2026
  3. Primary completionMar 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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)
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

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.

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