NCT01911481

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 10, 2015

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

July 22, 2013

Last Update Submit

December 9, 2015

Conditions

External Cephalic VersionMaternal Oral Hydration

Outcome Measures

Primary Outcomes (1)

  • 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

    The primary outcome will be assessed by ultrasound examination, 5 minutes after ending of the external cephalic version

Secondary Outcomes (2)

  • amniotic fluid volume

    1 hour after the end of oral maternal hydration (2 litres)

  • type of birth

    at birth

Other Outcomes (3)

  • type of breech presentation

    Baseline

  • placental localisation

    baseline

  • foetal back position

    baseline

Study Arms (2)

hydration

EXPERIMENTAL

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

Other: hydration

control

NO INTERVENTION

Interventions

hydrationOTHER
hydration

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Gerardo Hospital

Monza, Monza Brianza, 20900, Italy

Location

Study Officials

  • Antonietta A Scian, MD

    San Gerardo Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2013

First Posted

July 30, 2013

Study Start

October 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

December 10, 2015

Record last verified: 2015-12

Locations

IT(1)