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NCT Number: NCT07313319

Trial of Underwater Birth

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location status: Recruiting

Location contact

Family Planning Research

CONTACT

[email protected]

505-205-4118

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Waterbirth

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. IV Narcotic Use

    Time frame: Labor and delivery

    Use of IV narcotics in labor

  2. Active Labor Duration

    Time frame: Labor and delivery

    duration of active labor

  3. Delivery Mode

    Time frame: Labor and delivery

    Mode of delivery

  4. Maternal Adverse Outcomes

    Time frame: Up to 2 weeks postpartum

    Composite maternal adverse outcomes

  5. Intermittent Auscultation (IA)

    Time frame: Labor and delivery

    Use of intermittent auscultation (IA)

  6. Neonatal Adverse Outcomes

    Time frame: Up to 2 weeks postpartum

    Composite neonatal adverse outcomes

  7. United States Birth Satisfaction Scale-Revised (US-BSS-R)

    Time frame: 3 days to 2 weeks postpartum

    Satisfaction with birth experience

Study contacts

Contact information is provided by the study sponsor or research team.

Family Planning Research

CONTACT

[email protected]

505-205-4118

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Official study title

Trial of Underwater Birth: A Randomized Control Trial

Acronym: TUB

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 31, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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