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Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

Sponsor
Aurora Health Care (Other)
Overall Status
Recruiting
CT.gov ID
NCT05175599
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
46.5
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Water Birth
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Women are randomized 1:2 land birth to waterbirth.Women are randomized 1:2 land birth to waterbirth.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Hospital Waterbirth: A Pilot Randomized Control Study
Actual Study Start Date :
Jan 17, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Land Birth

Women in the land birth group will labor and give birth according to standard of care procedures.
Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Pain Medication [Time of admission to birth of the baby]

    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.

Secondary Outcome Measures

  1. Labor duration [Time of labor onset to time of birth]

    The percent of women in the waterbirth cohort will have shorter labor duration than women in the land birth cohort.

  2. Rate of breastfeeding [Measured from birth (immediate) through discharge from hospital (24-48 hours)]

    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.

  3. Patient satisfaction based on the United States Birth Satisfaction Scale-Revised (US-BSS-R) [During postpartum hospital stay, starting at the time of birth until up to 72 hours from the time of birth]

    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"

  4. Reported maternal adverse outcomes [During labor and birth through the immediate postpartum hospital admission (24-48 hours after the birth)]

    The percent of women in the waterbirth cohort with reported adverse obstetric outcomes will be less than women in the land birth cohort.

  5. Reported neonatal adverse outcomes [Immediately after the birth until the time of the postpartum visit (usually 4 to 6 weeks of life)]

    The percent of neonates in the waterbirth cohort with reported adverse birth outcomes will be less than neonates in the land birth cohort.

  6. Instrumental and cesarean deliveries [Time of labor to time of delivery]

    The percent of neonates in the waterbirth cohort with instrumental and cesarean deliveries will be less than neonates in the land birth cohort.

  7. Skin-to-skin contact [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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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:

  1. Greater than 37 weeks and less than 42 completed weeks gestation in vertex presentation

  2. Not hypertensive or febrile (two blood pressures 140/90 four hours apart; two fevers of over 100.4 one hour apart)

  3. Category 1 fetal heart tones (obtained on a 20-minute admission external fetal monitor strip)

  4. 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aurora Sinai Medical Center Milwaukee Wisconsin United States 53233

Sponsors and Collaborators

  • Aurora Health Care

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Emily Malloy, Principal Investigator, Aurora Health Care
ClinicalTrials.gov Identifier:
NCT05175599
Other Study ID Numbers:
  • 20.176
First Posted:
Jan 4, 2022
Last Update Posted:
Apr 7, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 7, 2022