Waterbirth versus land birth for low‑risk laboring people
Trial of Underwater Birth: A Randomized Control Trial
This project will test if waterbirth reduces the need for epidurals and affects maternal and newborn outcomes for adult low‑risk laboring people compared with giving birth on land.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of New Mexico Academic / other |
| Locations | 1 site (Albuquerque, New Mexico) |
| Trial ID | NCT07313319 on ClinicalTrials.gov |
What this trial studies
This is a randomized pilot trial at the University of New Mexico that will assign adult low‑risk laboring people to deliver in water or on land. Eligible participants are term, singleton, vertex pregnancies with BMI <40, able to ambulate and speak English or Spanish, and without major obstetric or medical risk factors; randomization occurs at admission for labor. The primary outcome is use of epidural anesthesia and vaginal birth, with secondary outcomes including IV narcotic use, duration of active labor, mode of delivery, composite maternal and neonatal adverse outcomes, use of intermittent auscultation, and birth satisfaction. Analyses will follow intention‑to‑treat principles and the pilot will inform feasibility and sample size for a larger trial.
Who should consider this trial
Good fit: Adults (≥18) with a singleton, vertex pregnancy at term, BMI under 40, able to ambulate and speak English or Spanish, and without major maternal or fetal risk factors are ideal candidates.
Not a fit: People with high‑risk pregnancies (such as multiples, non‑vertex presentation, preterm labor, significant maternal medical conditions, class III obesity, or active fever/hypertension) or those planning cesarean delivery are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this approach could reduce epidural use, lower interventions, and improve maternal satisfaction for eligible low‑risk births.
How similar studies have performed: Existing evidence is mostly observational and mixed, with limited randomized data, so this pilot is relatively novel in testing waterbirth in a randomized design.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Albuquerque, New Mexico
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
Study contacts
- Principal investigator: Katrina Nardini — University of New Mexico
- Study coordinator: Family Planning Research
- Email: FamilyPlanningResearch@salud.unm.edu
- Phone: 505-205-4118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.