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Sevoflurane and Success of External Cephalic Version (ECV) (ECV)

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ClinicalTrials.gov Identifier: NCT04346823
Recruitment Status : Unknown
Verified April 2020 by Adel Alqarni, King Saud University.
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : April 24, 2020
Information provided by (Responsible Party):
Adel Alqarni, King Saud University

Brief 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.

Condition or disease Intervention/treatment Phase
Version of Uterus Drug: Sevoflurane Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Sevoflurane on the Success of External Cephalic Version for Breech Presentation
Estimated Study Start Date : May 25, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

Arm Intervention/treatment
Experimental: Sevoflurane

Each participant started by preoxygenation of 100% oxygen for 3 minutes. Then, parturients breath 1% of sevoflurane in mixture of oxygen and air (FIO2 0.5) by tight face mask with a gas flow of 6 L/min. Values of inspired (FI) and end-tidal (FET) concentrations of sevoflurane, oxygen and respiratory rate (RR) measured by end-tidal carbon dioxide (EtC02) were monitored continuously and recorded at 30 seconds intervals by a gas analyzer.

30 seconds after stating inhalation sedation, the obstetrician will be asked to start the procedure. HR, FI and FET concentration of sevoflurane, Sp02 and EtC02 will be recorded at 30-s interval during ECV. Non-invasive BP will be recorded every one minute. Duration of ECV in addition to level of difficulty estimated by obstetrician will be recorded.

ECV considered successful when a cephalic presentation, confirmed by ultrasound scan, achieved.

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.

Other Name: Sevorane

No Intervention: No sevoflurane
If the parturient is assigned to the control (nonintervention) group, the participants will not receive any medications neither tocolytics nor analgesics as the routine care in our hospital. However, the participants will be monitored throughout the procedure for vital signs and for pain scores as in the intervention group.

Primary Outcome Measures :
  1. The success rate of ECV under sevoflurane compared with that without sevoflurane in parturient undergoing elective ECV at 36-40 weeks of gestation. [ Time Frame: 20 minutes ]
    ECV considered successful when a cephalic presentation assessed by direct palpation of maternal abdominal wall by obstetrician and confirmed by ultrasound scan is achieved.

Secondary Outcome Measures :
  1. The pain score (by using visual analogue scale) during ECV under sevoflurane versus that during ECV without sevoflurane [ Time Frame: 20 minutes ]
    The visual analogous scale used for this study measures from 0-10 the intensity of the pain. Where, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).

  2. The duration of ECV under sevoflurane versus without sevoflurane [ Time Frame: 10 minutes ]
    The duration of ECV procedure in minutes

  3. The maternal satisfaction during ECV procedure between sevoflurane group versus control group [ Time Frame: 20 minutes ]
    The women's level of satisfaction with the procedure will be assessed using numerical rating scale (0 = completely dissatisfied, 10 = completely satisfied)

  4. The incidence rate of complications related to ECV between sevoflurane group versus control group [ Time Frame: 45 minutes ]
    These complications include such as placental abruption, cord prolapse, abnormal cardiotocography, fetomaternal transfers and stillbirth

  5. The incidence of adverse effects after administration of sevoflurane for ECV with that of control group. [ Time Frame: 45 minutes ]
    Possible adverse effects such as nausea, vomiting, drowsiness, hypotension and aspiration pneumonia.

  6. The mode of delivery (vaginal or cesarean) after successful ECV between sevoflurane versus control group [ Time Frame: 2 months ]
    mode of delivery might be either normal vaginal delivery or by cesarean section

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346823

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Contact: Adel Alqarni, MD +966540900123 adalqarni@ksu.edu.sa

Sponsors and Collaborators
King Saud University
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Principal Investigator: Adel Alqarni, MD King Saud University
Publications of Results:

Other Publications:
United States Food and Drug Administration. FDA drug safety communication: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women. Updated 2016. Accessed February/10, 2017.

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Responsible Party: Adel Alqarni, Assistant professor and consultant of anesthesia, King Saud University
ClinicalTrials.gov Identifier: NCT04346823    
Other Study ID Numbers: Sevoflurane for ECV
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Adel Alqarni, King Saud University:
Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs