Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes
NCT ID: NCT05175599
Last Updated: 2025-04-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
168 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-01-17
Study Completion Date
2023-12-23
Brief Summary
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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.
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Detailed Description
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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
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Pregnancy Related
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Women are randomized 1:2 land birth to waterbirth.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Land Birth
Women in the land birth group will labor and give birth according to standard of care procedures.
Group Type
NO_INTERVENTION
No interventions assigned to this group
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.
Group Type
EXPERIMENTAL
Water Birth
Intervention Type
OTHER
The water birth group will use a tub of a water to labor and give birth.
Interventions
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Water Birth
The water birth group will use a tub of a water to labor and give birth.
Intervention Type
OTHER
Eligibility Criteria
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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
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.
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).
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
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.
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).
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Locations
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Aurora Sinai Medical Center
Milwaukee, Wisconsin, United States
Site Status
Countries
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United States
References
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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.
Reference Type
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.
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
ACNM. Position statement: Hydrotherapy during labor and birth. 2014.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Nikodem VC. The effects of water birth: a randomised controlled trail. Thesis: Rand Afrikaans University, South Africa
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Dekker R, The Evidence on: Waterbirth, in Evidence Based Birth. 2018. https://evidencebasedbirth.com/waterbirth/
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Karimi, Laleh. Personal correspondence. (August 2019).
Reference Type
BACKGROUND
Other Identifiers
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20.176
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00106915
Identifier Type: -
Identifier Source: org_study_id
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