Trial of Underwater Birth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Waterbirth.
- Who it may be relevant to
- Registry conditions: Birth. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Trial of Underwater Birth: A Randomized Control Trial
Overview
Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.
Detailed description
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).
Interventions
- Procedure Waterbirth
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 outcome measures
- Epidural Anesthesia [Time frame: Labor and delivery]
Secondary outcome measures (7)
- IV Narcotic Use [Time frame: Labor and delivery]
- Active Labor Duration [Time frame: Labor and delivery]
- Delivery Mode [Time frame: Labor and delivery]
- Maternal Adverse Outcomes [Time frame: Up to 2 weeks postpartum]
- Intermittent Auscultation (IA) [Time frame: Labor and delivery]
- Neonatal Adverse Outcomes [Time frame: Up to 2 weeks postpartum]
- United States Birth Satisfaction Scale-Revised (US-BSS-R) [Time frame: 3 days to 2 weeks postpartum]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of New Mexico — Albuquerque
Identifiers
NCT: NCT07313319 · 25-454 · Lacks Grant