Trial of Underwater Birth

Официальное название

Trial of Underwater Birth: A Randomized Control Trial

Обзор

Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.

Подробное описание

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).

Вмешательства

• Процедура 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.

Первичные конечные точки

• Epidural Anesthesia [Срок оценки: Labor and delivery]

Вторичные конечные точки (7)

• IV Narcotic Use [Срок оценки: Labor and delivery]
• Active Labor Duration [Срок оценки: Labor and delivery]
• Delivery Mode [Срок оценки: Labor and delivery]
• Maternal Adverse Outcomes [Срок оценки: Up to 2 weeks postpartum]
• Intermittent Auscultation (IA) [Срок оценки: Labor and delivery]
• Neonatal Adverse Outcomes [Срок оценки: Up to 2 weeks postpartum]
• United States Birth Satisfaction Scale-Revised (US-BSS-R) [Срок оценки: 3 days to 2 weeks postpartum]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of New Mexico — Albuquerque

Идентификаторы

NCT: NCT07313319 · 25-454 · Lacks Grant

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗