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
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|Condition or disease||Intervention/treatment||Phase|
|Version of Uterus||Drug: Sevoflurane||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- 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).
- The duration of ECV under sevoflurane versus without sevoflurane [ Time Frame: 10 minutes ]The duration of ECV procedure in minutes
- 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)
- 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
- 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.
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Contact: Adel Alqarni, MDfirstname.lastname@example.org|
|Principal Investigator:||Adel Alqarni, MD||King Saud University|
|Responsible Party:||Adel Alqarni, Assistant professor and consultant of anesthesia, King Saud University|
|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|
|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|
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