NCT04239300

Brief Summary

Water birth are not risks factors for newborns.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,080

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

March 11, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2021

Completed
Last Updated

May 21, 2021

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

January 9, 2020

Last Update Submit

May 19, 2021

Conditions

Water Birth

Keywords

water birth

Outcome Measures

Primary Outcomes (1)

  • Perineal trauma

    The number and percentage of perineal trauma during labour

    1 day

Secondary Outcomes (3)

  • Episiotomy

    1 day

  • Newborns wellbeing

    1 day

  • Infections complications from newborns

    3 days

Study Arms (2)

Main group

EXPERIMENTAL

The participant in main group have water labour

Behavioral: Delivery in water

Control group

NO INTERVENTION

The participant in control group will not have water labour

Interventions

Delivery in waterBEHAVIORAL

Participants delivery in water

Main group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OOO MD proect 2010

Ufa, Bashkortostan Republic, 450071, Russia

Location

Schelkovo Perinatal Center

Moscow, Moscow Oblast, 141100, Russia

Location

MeSH Terms

Interventions

ParturitionWater

Intervention Hierarchy (Ancestors)

PregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 27, 2020

Study Start

March 11, 2020

Primary Completion

April 27, 2021

Study Completion

April 27, 2021

Last Updated

May 21, 2021

Record last verified: 2020-03

Locations

RU(2)