Efficiency and Safety of Water Birth

Efficiency and Safety of Water Birth in Maternity Hospitals in Uncomplicated Pregnancy.

Water birth are not risks factors for newborns.

Study Overview

• Status: Completed
• Conditions: Water Birth
• Intervention / Treatment: Behavioral: Delivery in water

Detailed Description

Investigators will study medical records of woman who have water birth and evaluate different parameters. Study lasts from February 2020 till April 2021. The questionnaire contain information about woman's expectations of labour Number of participant is approximately 500.

• Study Type: Interventional
• Enrollment (Actual): 1080
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Bashkortostan
    • Ufa, Bashkortostan, Russian Federation, 450071
      • OOO MD proect 2010
  • Moscow Region
    • Moscow, Moscow Region, Russian Federation, 141100
      • Schelkovo Perinatal Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• delivery alive newborn in water
• age 18-45
• single pregnancy

Exclusion Criteria:

• antenatal death
• dead fetus
• age under 18 and up 45
• multiple pregnancy
• somatic diseases
• preeclampsia
• mental diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main group; The participant in main group have water labour	Behavioral: Delivery in water; Participants delivery in water
No Intervention: Control group; The participant in control group will not have water labour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perineal trauma	The number and percentage of perineal trauma during labour	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episiotomy	The number and percentage of episiotomy trauma during labour	1 day
Newborns wellbeing	Apgar scale	1 day
Infections complications from newborns	The number of Infections complications	3 days

Collaborators and Investigators

• Sponsor: Akusherstvo Pro

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2020
• Primary Completion (Actual): April 27, 2021
• Study Completion (Actual): April 27, 2021

Study Registration Dates

• First Submitted: January 9, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: water birth
• Other Study ID Numbers: AlusherstvoPro

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No