Hospital Waterbirth Trial to Measure Maternal and Neonatal Outcomes

Wake Forest University (WFU)

Status

Completed

Conditions

Pregnancy Related

Treatments

Other: Water Birth

Study type

Interventional

Funder types

Other

Identifiers

NCT05175599

IRB00106915

20.176

Details and patient eligibility

About

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.

Full 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.

Enrollment

168 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).