External Cephalic VersionNCT01911481
Maternal Oral Hydration and External Cephalic Version
A study testing hydration in people with External Cephalic Version and Maternal Oral Hydration, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
The investigators are carrying out a study of 164 pregnant women, with breech presentation at term who will undergo to external cephalic version. The investigators' goal is to know if oral maternal hydration can increase the successful of external cephalic version Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- External Cephalic Version, Maternal Oral Hydration
- What is being tested?
- hydration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2011to Jan 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single gestation
- breech presentation
- from 37 to 41,5 weeks
- without pregnancy complications
- fetus adequate for gestational age
- without fetal malformations
Show all 9Show fewer
- intact membranes
- amniotic fluid index between 7 and 24 cm
- placenta properly inserted
Who cannot join
- age less than 18 years
- maternal disease at risk of fluid overload (cardiac disease, renal impairment, moderate or severe preeclampsia or hypertension and diabetes)
- contraindications for vaginal birth
- vaginal blood loss
- uterine contractions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Maternal Oral Hydration and External Cephalic Version: a Single Blind Randomised Controlled Trial
The investigators are carrying out a study of 164 pregnant women, with breech presentation at term who will undergo to external cephalic version. The investigators' goal is to know if oral maternal hydration can increase the successful of external cephalic version
- Conditions
- External Cephalic Version, Maternal Oral Hydration
- Being tested
- hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrationOther
| Study group | Role | What they receive |
|---|---|---|
| hydration | Experimental | after recruitment the women in hydration group will be invited to drink 2 litres of water,in 2 hours Receives: Other: hydration |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with external cephalic version successful after maternal oral hydration
The primary outcome of the study is to evaluate the successful rate of external cephalic version, after oral intake of two litres of water
Measured: The primary outcome will be assessed by ultrasound examination, 5 minutes after ending of the external cephalic version
Secondary outcomes (2)
amniotic fluid volume
We will assess the amniotic fluid index at recruitment (Baseline). 1 hour after ending of oral intake (2 litres of water), we will revalue the amniotic fluid volume
Measured: 1 hour after the end of oral maternal hydration (2 litres)
type of birth
We will record if the woman will give birth by cesarean section or vaginal birth (spontaneous or operative)
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Cephalic VersionStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonietta A Scian, MD, Study chair, San Gerardo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911481
- Sponsor's protocol ID
- IDRI
- Status last verified
- Dec 2015
- First submitted
- 22 Jul 2013
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Oral Hydration and External Cephalic Version: a Single Blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01911481
- Acronym / sponsor ID
- IDRI
- Conditions
- External Cephalic Version, Maternal Oral Hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Jul 2013 (estimated)
- 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.
The investigators are carrying out a study of 164 pregnant women, with breech presentation at term who will undergo to external cephalic version. The investigators' goal is to know if oral maternal hydration can increase the successful of external cephalic version
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydration | Experimental | Other: hydrationafter recruitment the women in hydration group will be invited to drink 2 litres of water,in 2 hours |
| control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- single gestation
- breech presentation
- from 37 to 41,5 weeks
- without pregnancy complications
- fetus adequate for gestational age
Key exclusion criteria (5 listed)
- age less than 18 years
- maternal disease at risk of fluid overload (cardiac disease, renal impairment, moderate or severe preeclampsia or hypertension and diabetes)
- contraindications for vaginal birth
- vaginal blood loss
- uterine contractions
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 |
|---|---|---|
| hydration | Other | hydration |
Primary outcome
Number of participants with external cephalic version successful after maternal oral hydration
Time frame: The primary outcome will be assessed by ultrasound examination, 5 minutes after ending of the external cephalic version
The primary outcome of the study is to evaluate the successful rate of external cephalic version, after oral intake of two litres of water
2 secondary outcomes
amniotic fluid volume
Time frame: 1 hour after the end of oral maternal hydration (2 litres)
type of birth
Time frame: at birth
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 10 Dec 2015.
Related trials for External Cephalic Version
Recruiting
Mindfulness-based Intervention Prior to External Cephalic Version
Breech Presentation in Pregnancy, External Cephalic Version
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.
Antonietta A Scian, MD study chair
San Gerardo Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hydration in people with External Cephalic Version and Maternal Oral Hydration, run by University of Milano Bicocca at 1 site in Italy.
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 9 inclusion and 5 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Number of participants with external cephalic version successful after maternal oral hydration (time frame: The primary outcome will be assessed by ultrasound examination, 5 minutes after ending of the external cephalic version). 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 10 Dec 2015; AzTrials last refreshed its copy on 29 Oct 2026.