External Cephalic Version, Maternal Oral Hydration
Conditions
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
Interventions
OTHERhydration
Sponsors
University of Milano Bicocca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| type of breech presentation | Baseline | At recruitment we will assess the type of breech (frank breech, complete breech, footling or incomplete breech) |
| placental localisation | baseline | At recruitment we will assess the placental localisation (anterior, posterior, right lateral, left lateral or fundal) |
| foetal back position | baseline | At recruitment we will evaluate the position of fetal back (anterior, posterior, right or left lateral) |
Countries
Italy
Outcome results
None listed