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Maternal Oral Hydration and External Cephalic Version

NCT ID: NCT01911481

Last Updated: 2015-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-01-31

Brief Summary

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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

Detailed Description

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Conditions

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External Cephalic Version Maternal Oral Hydration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Caregivers

Study Groups

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hydration

after recruitment the women in hydration group will be invited to drink 2 litres of water,in 2 hours

Group Type EXPERIMENTAL

hydration

Intervention Type OTHER

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hydration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* single gestation
* breech presentation
* from 37 to 41,5 weeks
* without pregnancy complications
* fetus adequate for gestational age
* without fetal malformations
* intact membranes
* amniotic fluid index between 7 and 24 cm
* placenta properly inserted

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonietta A Scian, MD

Role: STUDY_CHAIR

San Gerardo Hospital

Locations

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San Gerardo Hospital

Monza, Monza Brianza, Italy

Site Status

Countries

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Italy

Other Identifiers

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IDRI

Identifier Type: -

Identifier Source: org_study_id