Waterbirth versus land birth for low‑risk laboring people

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.