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Sevoflurane and Success of External Cephalic Version (ECV)

NCT04346823 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-24

No results posted yet for this study

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.

Conditions

  • Version of Uterus

Interventions

DRUG

Sevoflurane

Each participant started by preoxygenation of 100% oxygen for 3minutes. Then, parturients breath 1% of sevoflurane in a mixture of oxygen and air (FIO2 0.5) by tight face mask with a gas flow of 6 L/min. Thirty seconds after stating inhalation sedation, the obstetrician will be asked to start the procedure.The duration of ECV in addition to the level of difficulty estimated by obstetricians will be recorded. Usually, the duration of ECV does not exceed 10 minutes. The intervention will be stopped if the woman reported severe pain, if version could not be achieved readily, or if prolonged fetal bradycardia, uterine bleeding or placental abruption occurred. Parturient will be kept in Post Anesthesia Care Unit (PACU) for 45minutes. CTG will be monitored during PACU stay.

Sponsors & Collaborators

  • King Saud University

    lead OTHER

Principal Investigators

  • Adel Alqarni, MD · King Saud University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2021-03-31
Completion
2021-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04346823 on ClinicalTrials.gov