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| ID | Type | Description | Link |
|---|---|---|---|
| Lacks Grant | Other Identifier | University of New Mexico |
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Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| IV Narcotic Use | Use of IV narcotics in labor | Labor and delivery |
| Active Labor Duration | duration of active labor | Labor and delivery |
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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):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Family Planning Research | Contact | 505-205-4118 | FamilyPlanningResearch@salud.unm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Katrina Nardini | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Recruiting | Albuquerque | New Mexico | 87131 | United States |
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| ID | Term |
|---|---|
| D009321 | Natural Childbirth |
| ID | Term |
|---|---|
| D036801 | Parturition |
| D011247 | Pregnancy |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
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| Delivery Mode | Mode of delivery | Labor and delivery |
| Maternal Adverse Outcomes | Composite maternal adverse outcomes | Up to 2 weeks postpartum |
| Intermittent Auscultation (IA) | Use of intermittent auscultation (IA) | Labor and delivery |
| Neonatal Adverse Outcomes | Composite neonatal adverse outcomes | Up to 2 weeks postpartum |
| United States Birth Satisfaction Scale-Revised (US-BSS-R) | Satisfaction with birth experience | 3 days to 2 weeks postpartum |
| D012101 |
| Reproductive and Urinary Physiological Phenomena |