Pregnancy RelatedNCT05175599
Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes
A study testing Water Birth in people with Pregnancy Related, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Water Birth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2022to 23 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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, herpes simplex virus outbreak (on prophylaxis acceptable), group B strep positive is acceptable
Show all 13Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- Water Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water BirthOther
The water birth group will use a tub of a water to labor and give birth.
| Study group | Role | What they receive |
|---|---|---|
| Land Birth | No intervention | Women in the land birth group will labor and give birth according to standard of care procedures. |
| Water Birth | Experimental | 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. Receives: Other: Water Birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Women Using Intravenous Narcotic Analgesia and Epidural Anesthesia
The number of women in the waterbirth cohort who use IV narcotic and epidural anesthesia compared with the land birth cohort.
Measured: Time of admission to birth of the baby
Secondary outcomes (7)
Median Time of Labor Duration
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.
Measured: Time of labor onset to time of birth
United States Birth Satisfaction Scale-Revised (US-BSS-R) Score
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.
Measured: Up to 72 hours post delivery
Number of Reported Maternal Adverse Outcomes
The number of women in the waterbirth cohort with reported adverse maternal obstetric outcomes will be compared to the land birth cohort.
Measured: During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)
Number of Patients Breastfeeding
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: Measured from birth (immediate) through discharge from hospital (24-48 hours)
Number of Neonatal Adverse Outcomes
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.
Measured: 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
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.
Measured: Time of labor to time of delivery
Number of Patients With Skin-to-skin Contact
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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start17 Jan 2022
- Primary completion23 Dec 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women are randomized 1:2 land birth to waterbirth.
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Malloy, CNM, APNP, Principal investigator, emily.malloy@aah.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175599
- Sponsor's protocol ID
- IRB00106915
- Other IDs
- 20.176
- Status last verified
- Mar 2025
- First submitted
- 20 Sep 2021
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nutter E, Meyer S, Shaw-Battista J, Marowitz A. Waterbirth: an integrative analysis of peer-reviewed literature. J Midwifery Womens Health. 2014 May-Jun;59(3):286-319. doi: 10.1111/jmwh.12194.
PubMed 24850284Duffin C. Waterbirth findings reveal high levels of satisfaction: Royal College of Midwives annual conference reflects a further move away from medical interventions towards. Nursing Standard. 2004 May 26;18(37):8-9.
Cluett ER, Burns E. Immersion in water in labour and birth. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD000111. doi: 10.1002/14651858.CD000111.pub3.
PubMed 19370552Cluett ER, Burns E, Cuthbert A. Immersion in water during labour and birth. Cochrane Database Syst Rev. 2018 May 16;5(5):CD000111. doi: 10.1002/14651858.CD000111.pub4.
PubMed 29768662Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003934. doi: 10.1002/14651858.CD003934.pub2.
PubMed 19370591Shaw-Battista J. Systematic Review of Hydrotherapy Research: Does a Warm Bath in Labor Promote Normal Physiologic Childbirth? J Perinat Neonatal Nurs. 2017 Oct/Dec;31(4):303-316. doi: 10.1097/JPN.0000000000000260.
PubMed 28520654ACNM. Position statement: Hydrotherapy during labor and birth. 2014.
Committee Opinion No. 679: Immersion in Water During Labor and Delivery. Obstet Gynecol. 2016 Nov;128(5):e231-e236. doi: 10.1097/AOG.0000000000001771.
PubMed 27776074Maude RM, Foureur MJ. It's beyond water: stories of women's experience of using water for labour and birth. Women Birth. 2007 Mar;20(1):17-24. doi: 10.1016/j.wombi.2006.10.005. Epub 2006 Dec 14.
PubMed 17174165ACOG Committee Opinion No. 766: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2019 Feb;133(2):e164-e173. doi: 10.1097/AOG.0000000000003074.
PubMed 30575638Dahlen HG, Dowling H, Tracy M, Schmied V, Tracy S. Maternal and perinatal outcomes amongst low risk women giving birth in water compared to six birth positions on land. A descriptive cross sectional study in a birth centre over 12 years. Midwifery. 2013 Jul;29(7):759-64. doi: 10.1016/j.midw.2012.07.002. Epub 2012 Aug 11.
PubMed 22884894Pagano E, De Rota B, Ferrando A, Petrinco M, Merletti F, Gregori D. An economic evaluation of water birth: the cost-effectiveness of mother well-being. J Eval Clin Pract. 2010 Oct;16(5):916-9. doi: 10.1111/j.1365-2753.2009.01220.x.
PubMed 20590979Odent M. Birth under water. Lancet. 1983 Dec 24-31;2(8365-66):1476-7. doi: 10.1016/s0140-6736(83)90816-4. No abstract available.
PubMed 6140561Henderson J, Burns EE, Regalia AL, Casarico G, Boulton MG, Smith LA. Labouring women who used a birthing pool in obstetric units in Italy: prospective observational study. BMC Pregnancy Childbirth. 2014 Jan 14;14:17. doi: 10.1186/1471-2393-14-17.
PubMed 24423216Chaichian S, Akhlaghi A, Rousta F, Safavi M. Experience of water birth delivery in Iran. Arch Iran Med. 2009 Sep;12(5):468-71.
PubMed 19722768
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Waterbirth: A Pilot Randomized Control Study
- ClinicalTrials.gov ID
- NCT05175599
- Acronym / sponsor ID
- IRB00106915
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 5 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Women are randomized 1:2 land birth to waterbirth.
| Arm | Type | Receives |
|---|---|---|
| Land Birth | No intervention | –Women in the land birth group will labor and give birth according to standard of care procedures. |
| Water Birth | Experimental | Other: Water BirthWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Prenatal low-risk, healthy, adult women (greater than or equal to 18 years of age), including:
Key exclusion criteria (3 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Water BirthThe water birth group will use a tub of a water to labor and give birth. | Other | Water Birth |
Primary outcome
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.
7 secondary outcomes
Median Time of Labor Duration
Time frame: 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
Number of Reported Maternal Adverse Outcomes
Time frame: 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)
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)
Number of Patients With Neonates With Instrumental and Cesarean Deliveries
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24850284Nutter E, Meyer S, Shaw-Battista J, Marowitz A. Waterbirth: an integrative analysis of peer-reviewed literature. J Midwifery Womens Health. 2014 May-Jun;59(3):286-319. doi: 10.1111/jmwh.12194.
- BackgroundDuffin C. Waterbirth findings reveal high levels of satisfaction: Royal College of Midwives annual conference reflects a further move away from medical interventions towards. Nursing Standard. 2004 May 26;18(37):8-9.
- Background: PubMed 19370552Cluett ER, Burns E. Immersion in water in labour and birth. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD000111. doi: 10.1002/14651858.CD000111.pub3.
- Background: PubMed 29768662Cluett ER, Burns E, Cuthbert A. Immersion in water during labour and birth. Cochrane Database Syst Rev. 2018 May 16;5(5):CD000111. doi: 10.1002/14651858.CD000111.pub4.
- Background: PubMed 19370591Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003934. doi: 10.1002/14651858.CD003934.pub2.
- Background: PubMed 28520654Shaw-Battista J. Systematic Review of Hydrotherapy Research: Does a Warm Bath in Labor Promote Normal Physiologic Childbirth? J Perinat Neonatal Nurs. 2017 Oct/Dec;31(4):303-316. doi: 10.1097/JPN.0000000000000260.
- BackgroundACNM. Position statement: Hydrotherapy during labor and birth. 2014.
- Background: PubMed 27776074Committee Opinion No. 679: Immersion in Water During Labor and Delivery. Obstet Gynecol. 2016 Nov;128(5):e231-e236. doi: 10.1097/AOG.0000000000001771.
- Background: PubMed 17174165Maude RM, Foureur MJ. It's beyond water: stories of women's experience of using water for labour and birth. Women Birth. 2007 Mar;20(1):17-24. doi: 10.1016/j.wombi.2006.10.005. Epub 2006 Dec 14.
- Background: PubMed 30575638ACOG Committee Opinion No. 766: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2019 Feb;133(2):e164-e173. doi: 10.1097/AOG.0000000000003074.
- Background: PubMed 22884894Dahlen HG, Dowling H, Tracy M, Schmied V, Tracy S. Maternal and perinatal outcomes amongst low risk women giving birth in water compared to six birth positions on land. A descriptive cross sectional study in a birth centre over 12 years. Midwifery. 2013 Jul;29(7):759-64. doi: 10.1016/j.midw.2012.07.002. Epub 2012 Aug 11.
- Background: PubMed 20590979Pagano E, De Rota B, Ferrando A, Petrinco M, Merletti F, Gregori D. An economic evaluation of water birth: the cost-effectiveness of mother well-being. J Eval Clin Pract. 2010 Oct;16(5):916-9. doi: 10.1111/j.1365-2753.2009.01220.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Malloy, CNM, APNP principal investigator
emily.malloy@aah.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water Birth in people with Pregnancy Related, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Women Using Intravenous Narcotic Analgesia and Epidural Anesthesia (time frame: Time of admission to birth of the baby). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05175599, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.