Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

NCT05175599 | Completed Results

• 2 other identifiers: IRB0010691520.176
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

• 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.

  Time of admission to birth of the baby

Secondary Outcomes (7)

• Median Time of Labor Duration

  Time of labor onset to time of birth

• United States Birth Satisfaction Scale-Revised (US-BSS-R) Score

  Up to 72 hours post delivery

• Number of Reported Maternal Adverse Outcomes

  During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)

• Number of Patients Breastfeeding

  Measured from birth (immediate) through discharge from hospital (24-48 hours)

• Number of Neonatal Adverse Outcomes

  Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life)

Study Arms (2)

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.

Other: Water Birth

Interventions

Water Birth OTHER

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

Water Birth

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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.

You may not qualify if:

• Known need for cesarean section

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (39)

• 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.

  PMID: 24850284 BACKGROUND

• Duffin 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

• 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.

  PMID: 19370552 BACKGROUND

• Cluett 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.

  PMID: 29768662 BACKGROUND

• Lawrence 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.

  PMID: 19370591 BACKGROUND

• Shaw-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.

  PMID: 28520654 BACKGROUND

• ACNM. Position statement: Hydrotherapy during labor and birth. 2014.

  BACKGROUND

• Committee Opinion No. 679: Immersion in Water During Labor and Delivery. Obstet Gynecol. 2016 Nov;128(5):e231-e236. doi: 10.1097/AOG.0000000000001771.

  PMID: 27776074 BACKGROUND

• Maude 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.

  PMID: 17174165 BACKGROUND

• ACOG 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.

  PMID: 30575638 BACKGROUND

• Dahlen 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.

  PMID: 22884894 BACKGROUND

• Pagano 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.

  PMID: 20590979 BACKGROUND

• Odent 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.

  PMID: 6140561 BACKGROUND

• Henderson 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.

  PMID: 24423216 BACKGROUND

• Chaichian S, Akhlaghi A, Rousta F, Safavi M. Experience of water birth delivery in Iran. Arch Iran Med. 2009 Sep;12(5):468-71.

  PMID: 19722768 BACKGROUND

• Gayiti MR, Li XY, Zulifeiya AK, Huan Y, Zhao TN. Comparison of the effects of water and traditional delivery on birthing women and newborns. Eur Rev Med Pharmacol Sci. 2015;19(9):1554-8.

  PMID: 26004591 BACKGROUND

• Woodward J, Kelly SM. A pilot study for a randomised controlled trial of waterbirth versus land birth. BJOG. 2004 Jun;111(6):537-45. doi: 10.1111/j.1471-0528.2004.00132.x.

  PMID: 15198780 BACKGROUND

• Torkamani SA, Kangani F, Janani F. The effects of delivery in water on duration of delivery and pain compared with normal delivery. Pak J Med Sci. 2010; 26(3):551-5.

  BACKGROUND

• Ghasemi, M, Tara, F., Ashraf, H. Maternal-Fetal and Neonatal Complications of Water-Birth Compared with Conventional Delivery. The Iranian Journal of Obstetrics, Gynecology and Infertility. 2013; 16(70):9-15.

  BACKGROUND

• Nikodem VC. The effects of water birth: a randomised controlled trail. Thesis: Rand Afrikaans University, South Africa

  BACKGROUND

• Alderdice F, Renfrew M, Marchant S, Ashurst H, Hughes P, Berridge G, Garcia J. Labour and birth in water in England and Wales. BMJ. 1995 Apr 1;310(6983):837. doi: 10.1136/bmj.310.6983.837. No abstract available.

  PMID: 7711622 BACKGROUND

• Bovbjerg ML, Cheyney M, Everson C. Maternal and Newborn Outcomes Following Waterbirth: The Midwives Alliance of North America Statistics Project, 2004 to 2009 Cohort. J Midwifery Womens Health. 2016 Jan-Feb;61(1):11-20. doi: 10.1111/jmwh.12394. Epub 2016 Jan 20.

  PMID: 26789485 BACKGROUND

• Burns EE, Boulton MG, Cluett E, Cornelius VR, Smith LA. Characteristics, interventions, and outcomes of women who used a birthing pool: a prospective observational study. Birth. 2012 Sep;39(3):192-202. doi: 10.1111/j.1523-536X.2012.00548.x. Epub 2012 Jul 3.

  PMID: 23281901 BACKGROUND

• Demirel G, Moraloglu O, Celik IH, Erdeve O, Mollamahmutoglu L, Oguz SS, Uras N, Dilmen U. The effects of water birth on neonatal outcomes: a five-year result of a referral tertiary centre. Eur Rev Med Pharmacol Sci. 2013 May;17(10):1395-8.

  PMID: 23740455 BACKGROUND

• Geissbühler V, Eberhard, J. Waterbirths: A Comparative Study-A Prospective Study on More than 2,000 Waterbirths. Obstetrical & gynecological survey, 2001. 56(5): 260-262.

  BACKGROUND

• Zanetti-Dallenbach R, Lapaire O, Maertens A, Holzgreve W, Hosli I. Water birth, more than a trendy alternative: a prospective, observational study. Arch Gynecol Obstet. 2006 Oct;274(6):355-65. doi: 10.1007/s00404-006-0208-1. Epub 2006 Jul 26.

  PMID: 16868755 BACKGROUND

• Taylor H, Kleine I, Bewley S, Loucaides E, Sutcliffe A. Neonatal outcomes of waterbirth: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F357-65. doi: 10.1136/archdischild-2015-309600. Epub 2016 Apr 28.

  PMID: 27127204 BACKGROUND

• Vanderlaan J, Hall PJ, Lewitt M. Neonatal outcomes with water birth: A systematic review and meta-analysis. Midwifery. 2018 Apr;59:27-38. doi: 10.1016/j.midw.2017.12.023. Epub 2017 Dec 26. No abstract available.

  PMID: 29353689 BACKGROUND

• Gilbert RE, Tookey PA. Perinatal mortality and morbidity among babies delivered in water: surveillance study and postal survey. BMJ. 1999 Aug 21;319(7208):483-7. doi: 10.1136/bmj.319.7208.483.

  PMID: 10454400 BACKGROUND

• Davies R, Davis D, Pearce M, Wong N. The effect of waterbirth on neonatal mortality and morbidity: a systematic review and meta-analysis. JBI Database System Rev Implement Rep. 2015 Oct;13(10):180-231. doi: 10.11124/jbisrir-2015-2105.

  PMID: 26571292 BACKGROUND

• Dekker R, The Evidence on: Waterbirth, in Evidence Based Birth. 2018. https://evidencebasedbirth.com/waterbirth/

  BACKGROUND

• Bodner K, Bodner-Adler B, Wierrani F, Mayerhofer K, Fousek C, Niedermayr A, Grunberger W. Effects of water birth on maternal and neonatal outcomes. Wien Klin Wochenschr. 2002 Jun 14;114(10-11):391-5.

  PMID: 12708093 BACKGROUND

• Fehervary P, Lauinger-Lorsch E, Hof H, Melchert F, Bauer L, Zieger W. Water birth: microbiological colonisation of the newborn, neonatal and maternal infection rate in comparison to conventional bed deliveries. Arch Gynecol Obstet. 2004 Jul;270(1):6-9. doi: 10.1007/s00404-002-0467-4. Epub 2003 Sep 3.

  PMID: 12955529 BACKGROUND

• Fleming SE, Donovan-Batson C, Burduli E, Barbosa-Leiker C, Hollins Martin CJ, Martin CR. Birth Satisfaction Scale/Birth Satisfaction Scale-Revised (BSS/BSS-R): A large scale United States planned home birth and birth centre survey. Midwifery. 2016 Oct;41:9-15. doi: 10.1016/j.midw.2016.07.008. Epub 2016 Jul 7.

  PMID: 27494569 BACKGROUND

• A Model Practice Template for Hydrotherapy in Labor and Birth. J Midwifery Womens Health. 2017 Jan;62(1):120-126. doi: 10.1111/jmwh.12587. Epub 2016 Nov 24. No abstract available.

  PMID: 27883366 BACKGROUND

• Barbosa-Leiker C, Fleming S, Hollins Martin CJ, Martin CR. Psychometric properties of the Birth Satisfaction Scale-Revised (BSS-R) for US mothers. Journal of Reproductive and Infant Psychology. 2015; 33(5):504-11.

  BACKGROUND

• Hollins Martin CJ, Martin CR. Development and psychometric properties of the Birth Satisfaction Scale-Revised (BSS-R). Midwifery. 2014 Jun;30(6):610-9. doi: 10.1016/j.midw.2013.10.006. Epub 2013 Oct 24.

  PMID: 24252712 BACKGROUND

• Fetal Heart Monitoring. J Obstet Gynecol Neonatal Nurs. 2015 Sep-Oct;44(5):683-6. doi: 10.1111/1552-6909.12743. Epub 2015 Jul 15. No abstract available.

  PMID: 26183597 BACKGROUND

• Karimi, Laleh. Personal correspondence. (August 2019).

  BACKGROUND

MeSH Terms

Interventions

Natural Childbirth

Intervention Hierarchy (Ancestors)

Parturition; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Emily Malloy, PhD, CNM
• Organization: Aurora Health Care

emily.malloy@aah.org

4142195733

Study Officials

• Emily Malloy, CNM, APNP

  emily.malloy@aah.org

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Women are randomized 1:2 land birth to waterbirth.

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: January 4, 2022
• Study Start: January 17, 2022
• Primary Completion: December 23, 2023
• Study Completion: December 23, 2023
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)