Water Birth for Pregnancy

Overseen By Jessica Kram, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Aurora Health Care

Disqualifiers: Heart disease, Uncontrolled asthma, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

168 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Emily Malloy, CNM, APNP

Principal Investigator

[e-mail]

Eligibility Criteria

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.

Inclusion Criteria

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

Labor inclusion criteria:

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

Exclusion Criteria

Known need for cesarean section

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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Women eligible for a waterbirth are randomized to either waterbirth or land birth at the beginning of the third trimester

9 weeks

Labor and Delivery

Participants undergo labor and delivery either in water or on land, with data collected on pain medication use, labor duration, and delivery outcomes

Time of labor onset to time of birth

Postpartum Hospital Stay

Participants are monitored for maternal satisfaction, breastfeeding initiation, and adverse outcomes during their postpartum hospital stay

24-72 hours

Follow-up

Participants are monitored for safety and effectiveness after delivery, with data collected on neonatal outcomes and maternal satisfaction

4-8 weeks

Treatment Details

Interventions

• Water Birth

Trial Overview 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.

Participant Groups

Group I: Water Birth Experimental Treatment 1 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 Birth Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Aurora Health Care

Lead Sponsor

Trials

46

Recruited

16,400+

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+