Water BirthNCT04239300
Efficiency and Safety of Water Birth
A study testing Delivery in water in people with Water Birth, run by Akusherstvo Pro at 2 sites in Russia.
Trial summary
Water birth are not risks factors for newborns. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Water Birth
- What is being tested?
- Delivery in water
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,080 participants
- Where
- 2 sitesRussia
- Study dates
- 11 Mar 2020to 27 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- delivery alive newborn in water
- age 18-45
- single pregnancy
Who cannot join
- antenatal death
- dead fetus
- age under 18 and up 45
- multiple pregnancy
- somatic diseases
- preeclampsia
- mental diseases
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
Schelkovo Perinatal Center
Moscow, Moscow Oblast, 141100
OOO MD proect 2010
Ufa, Bashkortostan Republic, 450071
About this study
Official title: Efficiency and Safety of Water Birth in Maternity Hospitals in Uncomplicated Pregnancy.
Water birth are not risks factors for newborns.
Read the 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.
- Conditions
- Water Birth
- Being tested
- Delivery in water
- Keywords
- water birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery in waterBehavioural
Participants delivery in water
| Study group | Role | What they receive |
|---|---|---|
| Main group | Experimental | The participant in main group have water labour Receives: Behavioral: Delivery in water |
| Control group | No intervention | The participant in control group will not have water labour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perineal trauma
The number and percentage of perineal trauma during labour
Measured: 1 day
Secondary outcomes (3)
Episiotomy
The number and percentage of episiotomy trauma during labour
Measured: 1 day
Newborns wellbeing
Apgar scale
Measured: 1 day
Infections complications from newborns
The number of Infections complications
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start11 Mar 2020
- Primary completion27 Apr 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Water BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,080 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akusherstvo Pro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239300
- Sponsor's protocol ID
- AlusherstvoPro
- Status last verified
- Mar 2020
- First submitted
- 9 Jan 2020
- Last updated
- 21 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety of Water Birth in Maternity Hospitals in Uncomplicated Pregnancy.
- ClinicalTrials.gov ID
- NCT04239300
- Acronym / sponsor ID
- AlusherstvoPro
- Conditions
- Water Birth
- Keywords
- water birth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,080 participants (actual)
- Lead sponsor
- Akusherstvo ProUniversity, hospital or other
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main group | Experimental | Behavioral: Delivery in waterThe participant in main group have water labour |
| Control group | No intervention | –The participant in control group will not have water labour |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- delivery alive newborn in water
- age 18-45
- single pregnancy
Key exclusion criteria (7 listed)
- antenatal death
- dead fetus
- age under 18 and up 45
- multiple pregnancy
- somatic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivery in waterParticipants delivery in water | Behavioural | Main group |
Primary outcome
Perineal trauma
Time frame: 1 day
The number and percentage of perineal trauma during labour
3 secondary outcomes
Episiotomy
Time frame: 1 day
Newborns wellbeing
Time frame: 1 day
Infections complications from newborns
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery in water in people with Water Birth, run by Akusherstvo Pro at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perineal trauma (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2021.