Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hospital Waterbirth: A Pilot Randomized Control Study

Conditions
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Pregnancy Related

Intervention / Treatment
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* Other: Water Birth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Women are randomized 1:2 land birth to waterbirth.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Land Birth<br>Women in the land birth group will labor and give birth according to standard of care procedures. | |
| Experimental: Water Birth<br>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. | Other: Water Birth<br>* The water birth group will use a tub of a water to labor and give birth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Medication | 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. | Time of admission to birth of the baby | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Labor duration | The percent of women in the waterbirth cohort will have shorter labor duration than women in the land birth cohort. | Time of labor onset to time of birth | 
| Rate of breastfeeding | The percent of women in the waterbirth cohort who initiate immediately after the birth breastfeeding will be higher than women in the land birth cohort. | Measured from birth (immediate) through discharge from hospital (24-48 hours) | 
| Patient satisfaction based on the United States Birth Satisfaction Scale-Revised (US-BSS-R) | Women in the waterbirth cohort will have higher scores on the US-BSS-R scale during their postpartum hospital stay (up to 72 hours after the time of birth) than women in the land birth cohort. The US-BSS-R is a 10 question scale using a 5 point Likert scale with answers ranging from strongly agree to strongly disagree | During postpartum hospital stay, starting at the time of birth until up to 72 hours from the time of birth | 
| Reported maternal adverse outcomes | The percent of women in the waterbirth cohort with reported adverse obstetric outcomes will be less than women in the land birth cohort. | During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth) | 
| Reported neonatal adverse outcomes | The percent of neonates in the waterbirth cohort with reported adverse birth outcomes will be less than neonates in the land birth cohort. | Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life) | 
| Instrumental and cesarean deliveries | The percent of neonates in the waterbirth cohort with instrumental and cesarean deliveries will be less than neonates in the land birth cohort. | Time of labor to time of delivery | 
| Skin-to-skin contact | Neonates in the waterbirth cohort will have longer duration in minutes of skin-to-skin contact (on the maternal abdomen or chest) when compared with neonates in the land birth cohort. | 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. |