Trial of Underwater Birth
ConditionBirth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of New Mexico
About this trial
Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age
Able to speak and understand English or Spanish
Singleton gestation
Vertex presentation
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Waterbirth
Procedure/SurgeryThose 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.
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Land BirthNo intervention 0 interventions
Group B: WaterbirthExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Labor and deliverySecondary outcomes
1
IV Narcotic Use
Use of IV narcotics in labor
Time frame
Labor and delivery2
Active Labor Duration
duration of active labor
Time frame
Labor and delivery3
Delivery Mode
Mode of delivery
Time frame
Labor and delivery4
Maternal Adverse Outcomes
Composite maternal adverse outcomes
Time frame
Up to 2 weeks postpartumSponsors and contacts
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Source ClinicalTrials.gov