University of New Mexico
Albuquerque, New Mexico, 87131, United States
Location status: Recruiting
NCT Number: NCT07313319
Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Albuquerque, New Mexico, 87131, United States
Location status: Recruiting
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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):
Labor inclusion criteria (to be assessed at time of admission):
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):
Labor exclusion criteria (to be assessed at the time of admission):
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.
Time frame: Labor and delivery
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.
Time frame: Labor and delivery
Use of IV narcotics in labor
Time frame: Labor and delivery
duration of active labor
Time frame: Labor and delivery
Mode of delivery
Time frame: Up to 2 weeks postpartum
Composite maternal adverse outcomes
Time frame: Labor and delivery
Use of intermittent auscultation (IA)
Time frame: Up to 2 weeks postpartum
Composite neonatal adverse outcomes
Time frame: 3 days to 2 weeks postpartum
Satisfaction with birth experience
Contact information is provided by the study sponsor or research team.
University of New Mexico
Other
Trial of Underwater Birth: A Randomized Control Trial
Acronym: TUB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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