Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

Pregnancy Related Clinical Trial

Official title:

Hospital Waterbirth: A Pilot Randomized Control Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05175599
• Other study ID #: 20.176
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 17, 2022
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 breastfeeding prior to discharge, will not experience more negative outcomes, and will experience greater satisfaction than women who labor and birth on land.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: December 2025
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Other:
• Water Birth
The water birth group will use a tub of a water to labor and give birth.

Locations

Country	Name	City	State
United States	Aurora Sinai Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

References & Publications (39)

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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.

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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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Medication	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.	Time of admission to birth of the baby
Secondary	Labor duration	The percent of women in the waterbirth cohort will have shorter labor duration than women in the land birth cohort.	Time of labor onset to time of birth
Secondary	Rate of breastfeeding	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.	Measured from birth (immediate) through discharge from hospital (24-48 hours)
Secondary	Patient satisfaction based on the United States Birth Satisfaction Scale-Revised (US-BSS-R)	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"	During postpartum hospital stay, starting at the time of birth until up to 72 hours from the time of birth
Secondary	Reported maternal adverse outcomes	The percent of women in the waterbirth cohort with reported adverse obstetric outcomes will be less than women in the land birth cohort.	During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)
Secondary	Reported neonatal adverse outcomes	The percent of neonates in the waterbirth cohort with reported adverse birth outcomes will be less than neonates in the land birth cohort.	Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life)
Secondary	Instrumental and cesarean deliveries	The percent of neonates in the waterbirth cohort with instrumental and cesarean deliveries will be less than neonates in the land birth cohort.	Time of labor to time of delivery
Secondary	Skin-to-skin contact	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.	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.