Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

Wake Forest University Health Sciences168 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

168

Conditions

Pregnancy Related

Interventions

Water BirthOTHER

The water birth group will use a tub of a water to labor and give birth.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Prenatal low-risk, healthy, adult women (greater than or equal to 18 years of age), including: 1. Able to speak and understand English 2. Women with a singleton gestation 3. Able to ambulate with no mobility restrictions (i.e., no difficulty getting from seated to standing) 4. Less than class III obesity (BMI \<40kg/m squared) at initiation of prenatal care 5. No active infections such as HIV, Hepatitis B, Hepatitis C, HSV outbreak (on prophylaxis acceptable), GBS positive is acceptable 6. 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 7. 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: 8. Greater than 37 weeks and less than 42 completed weeks gestation in vertex presentation 9. Not hypertensive or febrile (two blood pressures 140/90 four hours apart; two fevers of over 100.4 one hour apart) 10. Category 1 fetal heart tones (obtained on a 20-minute admission external fetal monitor strip) 11. 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: 1. Known need for cesarean section 2. 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).

Locations (1)

Aurora Sinai Medical Center

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

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 frame: Time of admission to birth of the baby

Secondary Outcomes

Labor duration

The percent of women in the waterbirth cohort will have shorter labor duration than women in the land birth cohort.

Time frame: 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.

Time frame: 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"

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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