Maternal Oral Hydration and External Cephalic Version

External Cephalic Version Clinical Trial

Official title:

Maternal Oral Hydration and External Cephalic Version: a Single Blind Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911481
• Other study ID #: IDRI
• Status: Completed
• Phase: N/A
• First received: July 22, 2013
• Last updated: December 9, 2015
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: December 2015
• Source: University of Milano Bicocca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• External Cephalic Version
• Maternal Oral Hydration

Intervention

Other:
• hydration

Locations

Country	Name	City	State
Italy	San Gerardo Hospital	Monza	Monza Brianza

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	type of breech presentation	At recruitment we will assess the type of breech (frank breech, complete breech, footling or incomplete breech)	Baseline	No
Other	placental localisation	At recruitment we will assess the placental localisation (anterior, posterior, right lateral, left lateral or fundal)	baseline	No
Other	foetal back position	At recruitment we will evaluate the position of fetal back (anterior, posterior, right or left lateral)	baseline	No
Primary	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	No
Secondary	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)	No
Secondary	type of birth	We will record if the woman will give birth by cesarean section or vaginal birth (spontaneous or operative)	at birth	No