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Trial of Underwater Birth: A Randomized Control Trial

NCT ID: NCT07313319

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-12-31

Brief Summary

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Evaluate maternal perinatal outcomes in adult low-risk laboring people randomized to waterbirth compared to those randomized to birth on land.

Detailed Description

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The proposed randomized control trial will be approached as a pilot study to explore or test (if sample size permits) our hypotheses.

Primary outcome: Use of epidural anesthesia during labor and vaginal birth.

Secondary outcomes: Use of IV narcotics in labor, duration of active labor, mode of delivery, composite maternal adverse outcomes (see below), use of intermittent auscultation (IA), composite neonatal adverse outcomes (see below), United States Birth Satisfaction Scale-Revised (US-BSS-R), use of epidural analgesia during labor (full intention-to-treat analysis).

Conditions

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Birth

Keywords

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waterbirth landbirth epidural use birth outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Land Birth

Study subjects enrolled in the land birth cohort of this study will receive care as usual on labor and delivery. There will be no changes to their intrapartum care including their ability to use water as a form of pain relief during labor (Stage 1 water immersion) if deemed appropriate by their care team. Land birth participants who use water for pain relief will be assisted out of the water prior to second stage (pushing) as is currently routine on UNMH Labor and Delivery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Waterbirth

Subjects enrolled in the waterbirth cohort will be assessed for continued eligibility at time of admission to labor and delivery and continuously during labor. Those who remain eligible will have an inflatable birthing tub set up in their room and available for them to use as desired. Waterbirth will be performed in adherence to the following protocol endorsed by the American College of Nurse Midwives.

Group Type EXPERIMENTAL

Waterbirth

Intervention Type PROCEDURE

Those who remain eligible will have an inflatable birthing tub set up in their room and available for them to use as desired. Waterbirth will be performed in adherence to the following protocol endorsed by the American College of Nurse Midwives.

Interventions

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Waterbirth

Those who remain eligible will have an inflatable birthing tub set up in their room and available for them to use as desired. Waterbirth will be performed in adherence to the following protocol endorsed by the American College of Nurse Midwives.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

a. GBS positive is acceptable ii. Pre-existing medical conditions including heart disease, uncontrolled asthma, preexisting diabetes, chronic hypertension, or activity restrictions iii. High-risk pregnancy conditions including preeclampsia, gestational hypertension, preterm gestation, multiple gestation, gestational diabetes type A2, estimated fetal weight of 5000g for non-diabetics or \>4500 for GDM-A1, unstable substance use disorder (i.e. not in remission), placental abruption or other unexplained vaginal bleeding, previous cesarean section, fetal growth restriction (\<10th percentile), fetal anomaly, or other neonatal condition that may complicate neonatal transition to extrauterine life.

iv. Existing contraindication to vaginal birth
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katrina Nardini

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Central Contacts

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Family Planning Research

Role: CONTACT

Phone: 505-205-4118

Email: [email protected]

Other Identifiers

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Lacks Grant

Identifier Type: OTHER

Identifier Source: secondary_id

25-454

Identifier Type: -

Identifier Source: org_study_id