Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

Not Applicable

Completed

• Conditions: Pregnancy Related
• Interventions: Other: Water Birth

• Registration Number: NCT05175599
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-12-10
• Study First Posted: 2022-01-04
• Study Start: 2022-01-17
• Primary Completion: 2023-12-23
• Study Completion: 2023-12-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Water Birth	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.

Primary Outcome Measures

Name	Time	Method
Pain Medication	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.

Secondary Outcome Measures

Name	Time	Method
Instrumental and cesarean deliveries	Time of labor to time of delivery	The percent of neonates in the waterbirth cohort with instrumental and cesarean deliveries will be less than neonates in the land birth cohort.
Labor duration	Time of labor onset to time of birth	The percent of women in the waterbirth cohort will have shorter labor duration than women in the land birth cohort.
Rate of breastfeeding	Measured from birth (immediate) through discharge from hospital (24-48 hours)	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.
Reported neonatal adverse outcomes	Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life)	The percent of neonates in the waterbirth cohort with reported adverse birth outcomes will be less than neonates in the land birth cohort.
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	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"
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.	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.
Reported maternal adverse outcomes	During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)	The percent of women in the waterbirth cohort with reported adverse obstetric outcomes will be less than women in the land birth cohort.

Trial Locations

Locations (1)

Aurora Sinai Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States