Maternal Oral Hydration and External Cephalic Version

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

Study Overview

• Status: Completed
• Conditions: External Cephalic Version; Maternal Oral Hydration
• Intervention / Treatment: Other: hydration

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Monza Brianza
    • Monza, Monza Brianza, Italy, 20900
      • San Gerardo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control
Experimental: hydration; after recruitment the women in hydration group will be invited to drink 2 litres of water,in 2 hours	Other: hydration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	at birth

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
type of breech presentation	At recruitment we will assess the type of breech (frank breech, complete breech, footling or incomplete breech)	Baseline
placental localisation	At recruitment we will assess the placental localisation (anterior, posterior, right lateral, left lateral or fundal)	baseline
foetal back position	At recruitment we will evaluate the position of fetal back (anterior, posterior, right or left lateral)	baseline

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Investigators: Study Chair: Antonietta A Scian, MD, San Gerardo Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 26, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Estimate): December 10, 2015
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: IDRI