Efficiency and Safety of Water Birth | NCT04239300

Studies
Efficiency and Safety of Water Birth

NCT04239300

Sponsor

Akusherstvo Pro

Status

Completed

Last Update Posted

May 21, 2021Actual

Enrollment

1,080Actual

Phase

Not Applicable

Conditions

Water Birth

Interventions

Delivery in water

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2020Actual

Primary Completion Date

Apr 27, 2021Actual

Completion Date

Apr 27, 2021Actual

First Submitted Date

Jan 9, 2020

First Submission Date that Met QC Criteria

Jan 20, 2020

First Posted Date

Jan 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2021

Last Update Posted Date

May 21, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Water birth are not risks factors for newborns.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,080Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Delivery in water	Behavioral	Participants delivery in water	Main group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Episiotomy	The number and percentage of episiotomy trauma during labour	1 day
Newborns wellbeing	Apgar scale	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OOO MD proect 2010		Ufa	Bashkortostan Republic	450071	Russia
Schelkovo Perinatal Center

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D036801	Parturition
D014867	Water

Ancestor Terms

ID	Term
D011247	Pregnancy
D012098	Reproduction
D055703	Reproductive Physiological Phenomena
D012101	Reproductive and Urinary Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided