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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether giving birth in water (water birth) is better than the usual hospital method for women with low-risk pregnancies. The researchers aim to determine if water birth reduces the need for pain medicine, shortens labor, encourages earlier breastfeeding, and increases satisfaction without causing additional complications. Women who are healthy, pregnant with one baby, can move easily, and do not have certain health issues might be suitable for this trial. As an unphased study, this trial offers participants a unique opportunity to explore a potentially more satisfying birthing experience.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have pre-existing medical conditions that require continuous observation or activity restrictions.

What prior data suggests that water birth is safe for low-risk healthy women and neonates?

Research has shown that water birth is safe for both mothers and their babies. Studies have found no increased health risks for newborns delivered in water. For mothers, the risk of infections or other complications is not higher than with traditional land births. In fact, a large study found that water birth is a safe option for babies born at full term (37 weeks or later). Overall, water birth is well-accepted and does not result in more negative outcomes than regular birth methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about water birth because it offers a unique, potentially more natural birthing experience compared to traditional land births. Unlike conventional methods that take place in a hospital bed, water birth allows mothers to labor and deliver in water, which may help reduce labor pain and promote relaxation. This method is thought to create a calming environment, potentially leading to a more positive birthing experience for both mother and baby.

What evidence suggests that water birth is effective for pregnancy?

This trial will compare water birth with land birth. Studies have shown that giving birth in water benefits both mothers and babies. Research indicates that women who have water births often experience less pain and require fewer pain medications. This method may also shorten labor. Babies born in water typically have health outcomes similar to those born on land, with no increased risk of serious problems. Overall, water birth can be a safe and more comfortable choice for low-risk pregnancies. ^{1 3 4 6 7}

Who Is on the Research Team?

Emily Malloy, CNM, APNP

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. evidencebasedbirth.com evidencebasedbirth.com/waterbirth/

Evidence on Waterbirth In fact, babies born in the water had better health outcomes than babies born on land. The group that fared the worst were those who intended to ...

2. ajog.org ajog.org/article/S0002-9378(23)00604-X/fulltext

Water birth: a systematic review and meta-analysis ... Compared with land-based delivery, water birth was associated with significantly increased probability of umbilical cord avulsion (166/32,338 [ ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8983243/

Comparative Efficacy of Water and Conventional Delivery ... In this meta-analysis, it was seen that water delivery has clinical significance in alleviating the pain of mothers, promoting the safety of mothers and ...

4. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2016/11/immersion-in-water-during-labor-and-delivery

Immersion in Water During Labor and Delivery Immersion in water during the first stage of labor may be associated with shorter labor and decreased use of spinal and epidural analgesia.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34623074/

Neonatal Outcomes After Delivery in Water Conclusion: In this cohort of low-risk pregnant women, births in water and on land were associated with similar rates of admission to the NICU.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8004456/

Waterbirth: a national retrospective cohort study of factors ... For maternal and neonatal outcomes other than PPH, there is no evidence of a statistically significant association between water birth and adverse outcome. It ...

7. midwivesofnj.com midwivesofnj.com/largestwaterbirthstudyprovesitssafeformomsandbaby/

Largest Waterbirth Study Proves it's Safe for Mom and ... Dr. Priscilla Hall, and Dr. Mary Jane Lewitt have compiled, showing evidence that water birth is safe for term neonates, 37 weeks gestation and after.