Maternal Oral Hydration and External Cephalic Version

Not Applicable

Completed

• Conditions: External Cephalic Version; Maternal Oral Hydration
• Interventions: Other: hydration

• Registration Number: NCT01911481
• Lead Sponsor: University of Milano Bicocca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants with external cephalic version successful after maternal oral hydration	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

Secondary Outcome Measures

Name	Time	Method
amniotic fluid volume	1 hour after the end of oral maternal hydration (2 litres)	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
type of birth	at birth	We will record if the woman will give birth by cesarean section or vaginal birth (spontaneous or operative)

Trial Locations

Locations (1)

San Gerardo Hospital; 🇮🇹 Monza, Monza Brianza, Italy