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Completed

NCT Number: NCT01911481

Maternal Oral Hydration and External Cephalic Version

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

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Key information

Conditions

External Cephalic Version Maternal Oral Hydration

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Gerardo Hospital

Monza, Monza Brianza, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hydration

Other

Primary outcomes

  1. Number of participants with external cephalic version successful after maternal oral hydration

    Time frame: 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 outcomes

  1. amniotic fluid volume

    Time frame: 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

  2. type of birth

    Time frame: at birth

    We will record if the woman will give birth by cesarean section or vaginal birth (spontaneous or operative)

Other outcomes

  1. type of breech presentation

    Time frame: Baseline

    At recruitment we will assess the type of breech (frank breech, complete breech, footling or incomplete breech)

  2. placental localisation

    Time frame: baseline

    At recruitment we will assess the placental localisation (anterior, posterior, right lateral, left lateral or fundal)

  3. foetal back position

    Time frame: baseline

    At recruitment we will evaluate the position of fetal back (anterior, posterior, right or left lateral)

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2013
Registry last updated
Dec 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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