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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Less than class III obesity (BMI <40kg/m squared) at initiation of prenatal care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of labor onset to time of birth
Awards & highlights
Study Summary
This trial will compare waterbirth to land birth for low-risk, healthy women and their neonates in Milwaukee, WI. It hypothesizes that waterbirth may lead to less pain medication use, shorter labor, greater breastfeeding initiation, no negative outcomes, and greater satisfaction.
Who is the study for?
This trial is for healthy adult women over 18, pregnant with one baby in the correct position, between 37-42 weeks of gestation. They should have no severe obesity, high blood pressure, fever, mobility issues or infections like HIV/Hepatitis/HSV. Women with heart disease, uncontrolled asthma, diabetes or other serious conditions are excluded.Check my eligibility
What is being tested?
The study compares waterbirth to conventional land birth for low-risk pregnancies in a hospital setting. It will assess if waterbirth leads to less pain medication use, shorter labor time and higher satisfaction without increasing negative outcomes compared to land birth.See study design
What are the potential side effects?
While not explicitly listed as side effects in this context since it's a natural process comparison rather than drug intervention; potential risks may include infection risk from water contamination and possible perineal tearing.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I do not have chronic conditions like heart disease, uncontrolled asthma, diabetes, or high blood pressure.
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My BMI was below 40 when I started prenatal care.
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I can walk and move around without any help.
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I am pregnant with one baby.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of labor to time of delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of labor to time of delivery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Medication
Secondary outcome measures
Instrumental and cesarean deliveries
Labor duration
Patient satisfaction based on the United States Birth Satisfaction Scale-Revised (US-BSS-R)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Water BirthExperimental Treatment1 Intervention
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 II: Land BirthActive Control1 Intervention
Women in the land birth group will labor and give birth according to standard of care procedures.
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Who is running the clinical trial?
Aurora Health CareLead Sponsor
43 Previous Clinical Trials
16,074 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have chronic conditions like heart disease, uncontrolled asthma, diabetes, or high blood pressure.I am a healthy pregnant woman aged 18 or older.My BMI was below 40 when I started prenatal care.I can walk and move around without any help.I am pregnant with one baby.I do not have any active infections like HIV or Hepatitis.
Research Study Groups:
This trial has the following groups:- Group 1: Land Birth
- Group 2: Water Birth
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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