| NCT ID | NCT07313319 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of New Mexico |
| Condition | Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 230 participants in total. It began in 2026-04-21 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.
Eligibility 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
Contact & Investigator
Katrina Nardini
PRINCIPAL INVESTIGATOR
University of New Mexico
Frequently Asked Questions
Who can join the NCT07313319 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07313319 currently recruiting?
Yes, NCT07313319 is actively recruiting participants. Contact the research team at FamilyPlanningResearch@salud.unm.edu for enrollment information.
Where is the NCT07313319 trial being conducted?
This trial is being conducted at Albuquerque, United States.
Who is sponsoring the NCT07313319 clinical trial?
NCT07313319 is sponsored by University of New Mexico. The principal investigator is Katrina Nardini at University of New Mexico. The trial plans to enroll 230 participants.