Hospital Waterbirth: A Pilot Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- Pain Medication
研究概览
简要总结
This study aims to explore outcomes of waterbirth in comparison to conventional land birth for low-risk healthy women and neonates in a hospital setting in Milwaukee, WI. This study hypothesizes that women who labor and birth in water will use less pain medication, have a shorter labor, will be more likely to initiate breastfeeding prior to discharge, will not experience more negative outcomes, and will experience greater satisfaction than women who labor and birth on land.
详细描述
Women eligible for a waterbirth will be randomized (2:1) to either waterbirth or land birth at the beginning of the third trimester (25 weeks 0 days to 34 weeks 0 days gestation). The investigators recognize that some women will risk-out or opt-out because of the unpredictability of labor and birth. The goal is that approximately 50% of enrolled waterbirth participants give birth in water. Additionally, the investigators aim to approach the majority of patients eligible for waterbirth with the understanding that some women will not want to participate in a research study. Please note that given the variable nature of birth, once a woman is randomized and enrolled to either group, an intention to treat model will be used for analysis. Following birth, women will be asked to complete a validated questionnaire to evaluate maternal satisfaction prior to discharge. Other data will be collected from our electronic medical record or 4-8 weeks postpartum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Prenatal low-risk, healthy, adult women (greater than or equal to 18 years of age), including:
- •Able to speak and understand English
- •Women with a singleton gestation
- •Able to ambulate with no mobility restrictions (i.e., no difficulty getting from seated to standing)
- •Less than class III obesity (BMI <40kg/m squared) at initiation of prenatal care
- •No active infections such as HIV, Hepatitis B, Hepatitis C, HSV outbreak (on prophylaxis acceptable), GBS positive is acceptable
- •No pre-existing medical conditions such as: heart disease, uncontrolled asthma, diabetes of any type, chronic hypertension, or other condition that requires continuous observation and/or activity restrictions
- •No high-risk pregnancy conditions: including preeclampsia, gestational hypertension, preterm gestation, multiple gestation, substance abuse, placental abruption or other unexplained vaginal bleeding, previous cesarean section, suspected fetal macrosomia (>4500gm) or intrauterine growth restrictions (<10th percentile), or other condition that requires continuous observation and/or activity restrictions
- •Labor inclusion criteria:
- •Greater than 37 weeks and less than 42 completed weeks gestation in vertex presentation
- •Not hypertensive or febrile (two blood pressures 140/90 four hours apart; two fevers of over 100.4 one hour apart)
- •Category 1 fetal heart tones (obtained on a 20-minute admission external fetal monitor strip)
- •Amniotic sac may be intact or ruptured. If ruptured, amniotic fluid must be clear.
排除标准
- •Women will be excluded from the study if they do not meet above inclusion criteria or they will be further excluded under the following circumstances:
- •Known need for cesarean section
- •Participant may be excluded from the study at any time at the discretion of the birth attendant (reason for study exclusion will be documented but will remain in the study group previously selected based on intention to treat).
研究组 & 干预措施
Land Birth
Women in the land birth group will labor and give birth according to standard of care procedures.
Water Birth
Women in the water birth group will give birth in the water. During the first stage of labor, women may enter or leave the water at any point.
干预措施: Water Birth (Other)
结局指标
主要结局
Pain Medication
时间窗: Time of admission to birth of the baby
The percent of women in the waterbirth cohort who use IV narcotic and epidural anesthesia will be reduced when compared with the land birth cohort.
次要结局
- Instrumental and cesarean deliveries(Time of labor to time of delivery)
- Labor duration(Time of labor onset to time of birth)
- Rate of breastfeeding(Measured from birth (immediate) through discharge from hospital (24-48 hours))
- Reported neonatal adverse outcomes(Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life))
- Patient satisfaction based on the United States Birth Satisfaction Scale-Revised (US-BSS-R)(During postpartum hospital stay, starting at the time of birth until up to 72 hours from the time of birth)
- Skin-to-skin contact(Measured from time of birth (hour/minute) to time of skin-to-skin contact initiation (in number of minutes) up to 60 minutes of life.)
- Reported maternal adverse outcomes(During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth))