Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

April 30, 2026 updated by: Wake Forest University Health Sciences

Hospital Waterbirth: A Pilot Randomized Control Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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, herpes simplex virus outbreak (on prophylaxis acceptable), group B strep 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Women Using Intravenous Narcotic Analgesia and Epidural Anesthesia
Time Frame: Time of admission to birth of the baby
The number of women in the waterbirth cohort who use IV narcotic and epidural anesthesia compared with the land birth cohort.
Time of admission to birth of the baby

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Time of Labor Duration
Time Frame: Time of labor onset to time of birth
The median time of labor duration (1st stage onset of strong regular contractions resulting in cervical change, 2nd stage pushing and birth of the neonate, 3rd stage delivery of the placenta) of women in the waterbirth cohort will be compared to the land birth cohort.
Time of labor onset to time of birth
United States Birth Satisfaction Scale-Revised (US-BSS-R) Score
Time Frame: Up to 72 hours post delivery
The US-BSS-R is a 10 question scale using a 5 point Likert scale with answers ranging from "strongly agree" to "strongly disagree". The overall US-BSS-R total birth satisfaction score ranging from 0-40 (least birth satisfaction - most birth satisfaction). Women in the waterbirth cohort will be compared to those in the land birth cohort for overall US-BSS-R score.
Up to 72 hours post delivery
Number of Reported Maternal Adverse Outcomes
Time Frame: During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)
The number of women in the waterbirth cohort with reported adverse maternal obstetric outcomes will be compared to the land birth cohort.
During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)
Number of Patients Breastfeeding
Time Frame: Measured from birth (immediate) through discharge from hospital (24-48 hours)
The number of women in the waterbirth cohort who initiate immediately after the birth breastfeeding will be compared to those in the land birth cohort.
Measured from birth (immediate) through discharge from hospital (24-48 hours)
Number of Neonatal Adverse Outcomes
Time Frame: Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life)
The number of patients with neonates in the waterbirth cohort with reported adverse birth outcomes will be compared to patients with neonates in the land birth cohort.
Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life)
Number of Patients With Neonates With Instrumental and Cesarean Deliveries
Time Frame: Time of labor to time of delivery
The number of patients with neonates in the waterbirth cohort with instrumental and cesarean deliveries will be compared to patients with neonates in the land birth cohort.
Time of labor to time of delivery
Number of Patients With Skin-to-skin Contact
Time Frame: 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.
The number of patients with neonates in the waterbirth cohort with skin-to-skin contact will be compared with patients 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Emily Malloy, CNM, APNP, emily.malloy@aah.org

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2022

Primary Completion (Actual)

December 23, 2023

Study Completion (Actual)

December 23, 2023

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00106915
  • 20.176 (Other Identifier: Advocate Aurora Health Care)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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