Clinical trial NCT05175599: Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes
Official title: Hospital Waterbirth: A Pilot Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women are randomized 1:2 land birth to waterbirth.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Pain Medication
timeFrame: Time of admission to birth of the baby
Secondary outcomes:
measure: Labor duration
timeFrame: Time of labor onset to time of birth
measure: Rate of breastfeeding
timeFrame: Measured from birth (immediate) through discharge from hospital (24-48 hours)
measure: Patient satisfaction based on the United States Birth Satisfaction Scale-Revised (US-BSS-R)
timeFrame: During postpartum hospital stay, starting at the time of birth until up to 72 hours from the time of birth
measure: Reported maternal adverse outcomes
timeFrame: During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)
measure: Reported neonatal adverse outcomes
timeFrame: Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life)
measure: Instrumental and cesarean deliveries
timeFrame: Time of labor to time of delivery
measure: Skin-to-skin contact
timeFrame: 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.
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
Study officials:
affiliation: emily.malloy@aah.org
name: Emily Malloy, CNM, APNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: ACNM. Position statement: Hydrotherapy during labor and birth. 2014.
citation: Committee Opinion No. 679: Immersion in Water During Labor and Delivery. Obstet Gynecol. 2016 Nov;128(5):e231-e236. doi: 10.1097/AOG.0000000000001771.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Chaichian S, Akhlaghi A, Rousta F, Safavi M. Experience of water birth delivery in Iran. Arch Iran Med. 2009 Sep;12(5):468-71.
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.
citation: 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.
citation: 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.
citation: 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.
citation: Nikodem VC. The effects of water birth: a randomised controlled trail. Thesis: Rand Afrikaans University, South Africa
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: Dekker R, The Evidence on: Waterbirth, in Evidence Based Birth. 2018. https://evidencebasedbirth.com/waterbirth/
citation: 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.
citation: 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.
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.
citation: 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.
citation: 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.
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.
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.
citation: Karimi, Laleh. Personal correspondence. (August 2019).