Sevoflurane and Success of External Cephalic Version (ECV)

• Status: Not yet recruiting
• Trial end date: 2021-10-30
• Target enrollment: 0
• Participant gender: Female

Summary

External cephalic version (ECV) is noninvasive procedure aiming to turn the fetus to cephalic presentation, thereby enabling vaginal delivery and avoiding unnecessary cesarean delivery. The American College of Obstetricians and Gynecologists (ACOG) suggested that all women near term with breech presentation should be offered a version (9). Its success rate depends on the experience of obstetrician in addition to maternal factors. Several interventions have been tried to increase the success rate of ECV, including but not limited to tocolytics and neuraxial anesthesia. Although parenteral β stimulants and spinal anesthesia proved to be effective for increasing the success rate ECV, their success rates are still not high (10, 11) Sevoflurane's pleasant odor, lack of pungency, and potent bronchodilating characteristics make sevoflurane administration via the facemask for either sedation or induction of anesthesia is suitable. Sevoflurane has sedative and uterine relaxation effects all together would facilitate ECV and consequently would increase its success rate. To the best our knowledge sevoflurane has never been studied for ECV. Up to 1% concentration of sevoflurane has been used for labor analgesia without excessive sedation (8). Therefore, the investigators aim at comparing the success rate of ECV at 36-40 weeks of gestation under 1% of sevoflurane with a control group (received no anesthetic or other obstetric interventions). Other outcomes such as pain score and maternal and fetal complications will also be evaluated.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Saud University
• Treatments: Sevoflurane

Criteria

Inclusion Criteria:

• Patients > 18 years old

• ASA status I or II (healthy women or patient with mild well-controlled systemic disease)

• Elective ECV

• 36 to 40 weeks of gestation

Exclusion Criteria:

• Multifetal gestation

• Morbid obesity (BMI > 40 at first prenatal medical visit)

• Oligohydramnios or polyhydramnios (AFI <5 cm or > 23 cm)

• Fetal weight >4200g

• Active labor

• Uterine tumors or anomalies

• Abnormal placentation such as Placenta accreta/Previa

• Placental abruption

• Intrauterine fetal death

• Known allergy to sevoflurane

• History of malignant hyperthermia

• Administration of any tocolytics before or during ECV