Trial of Underwater Birth

NCT07313319 | Recruiting

• 2 other identifiers: 25-454Lacks Grant
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Birth

Keywords

waterbirth; landbirth; epidural use; birth outcomes

Outcome Measures

Primary Outcomes (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.

  Labor and delivery

Secondary Outcomes (7)

• IV Narcotic Use

  Labor and delivery

• Active Labor Duration

  Labor and delivery

• Delivery Mode

  Labor and delivery

• Maternal Adverse Outcomes

  Up to 2 weeks postpartum

• Intermittent Auscultation (IA)

  Labor and delivery

Study Arms (2)

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.

Procedure: Waterbirth

Interventions

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.

Waterbirth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• Greater than 37 weeks 0 days through and less than 412 completed weeks 6 days gestation with fetus in vertex presentation

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

RECRUITING

MeSH Terms

Interventions

Natural Childbirth

Intervention Hierarchy (Ancestors)

Parturition; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Katrina Nardini

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Family Planning Research

CONTACT

505-205-4118; FamilyPlanningResearch@salud.unm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: December 31, 2025
• Study Start: April 21, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)