Sevoflurane and Success of External Cephalic Version (ECV)

NCT04346823 | Unknown Phase 4

• 1 other identifier: Sevoflurane for ECV
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Version of Uterus

Keywords

Sevoflurane

Outcome Measures

Primary Outcomes (1)

• The success rate of ECV under sevoflurane compared with that without sevoflurane in parturient undergoing elective ECV at 36-40 weeks of gestation.

  ECV considered successful when a cephalic presentation assessed by direct palpation of maternal abdominal wall by obstetrician and confirmed by ultrasound scan is achieved.

  20 minutes

Secondary Outcomes (6)

• The pain score (by using visual analogue scale) during ECV under sevoflurane versus that during ECV without sevoflurane

  20 minutes

• The duration of ECV under sevoflurane versus without sevoflurane

  10 minutes

• The maternal satisfaction during ECV procedure between sevoflurane group versus control group

  20 minutes

• The incidence rate of complications related to ECV between sevoflurane group versus control group

  45 minutes

• The incidence of adverse effects after administration of sevoflurane for ECV with that of control group.

  45 minutes

Study Arms (2)

Sevoflurane

EXPERIMENTAL

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

No sevoflurane

NO INTERVENTION

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.

Interventions

Sevoflurane DRUG

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.

Also known as: Sevorane

Sevoflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years old
• ASA status I or II (healthy women or patient with mild well-controlled systemic disease)
• Elective ECV
• to 40 weeks of gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• King Saud University: lead

Related Publications (23)

• 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.

  BACKGROUND

• Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;2015(4):CD000083. doi: 10.1002/14651858.CD000083.pub3.

  PMID: 25828903 RESULT

• Hannah ME, Hannah WJ, Hewson SA, Hodnett ED, Saigal S, Willan AR. Planned caesarean section versus planned vaginal birth for breech presentation at term: a randomised multicentre trial. Term Breech Trial Collaborative Group. Lancet. 2000 Oct 21;356(9239):1375-83. doi: 10.1016/s0140-6736(00)02840-3.

  PMID: 11052579 RESULT

• Gregory KD, Jackson S, Korst L, Fridman M. Cesarean versus vaginal delivery: whose risks? Whose benefits? Am J Perinatol. 2012 Jan;29(1):7-18. doi: 10.1055/s-0031-1285829. Epub 2011 Aug 10.

  PMID: 21833896 RESULT

• Melo P, Georgiou EX, Hedditch A, Ellaway P, Impey L. External cephalic version at term: a cohort study of 18 years' experience. BJOG. 2019 Mar;126(4):493-499. doi: 10.1111/1471-0528.15475. Epub 2018 Oct 23.

  PMID: 30223309 RESULT

• Toscano A, Pancaro C, Giovannoni S, Minelli G, Baldi C, Guerrieri G, Crowhurst JA, Peduto VA. Sevoflurane analgesia in obstetrics: a pilot study. Int J Obstet Anesth. 2003 Apr;12(2):79-82. doi: 10.1016/S0959-289X(02)00195-4.

  PMID: 15321492 RESULT

• Suehara T, Morishita J, Ueki M, Ueno M, Maekawa N, Mizobuchi S. Effects of sevoflurane exposure during late pregnancy on brain development of offspring mice. Paediatr Anaesth. 2016 Jan;26(1):52-9. doi: 10.1111/pan.12785. Epub 2015 Oct 13.

  PMID: 26645425 RESULT

• Lee S, Chung W, Park H, Park H, Yoon S, Park S, Park J, Heo JY, Ju X, Yoon SH, Kim YH, Ko Y. Single and multiple sevoflurane exposures during pregnancy and offspring behavior in mice. Paediatr Anaesth. 2017 Jul;27(7):742-751. doi: 10.1111/pan.13139. Epub 2017 May 11.

  PMID: 28497474 RESULT

• Yeo ST, Holdcroft A, Yentis SM, Stewart A. Analgesia with sevoflurane during labour: i. Determination of the optimum concentration. Br J Anaesth. 2007 Jan;98(1):105-9. doi: 10.1093/bja/ael326.

  PMID: 17158128 RESULT

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins--Obstetrics. Practice Bulletin No. 161: External Cephalic Version. Obstet Gynecol. 2016 Feb;127(2):e54-61. doi: 10.1097/AOG.0000000000001312.

  PMID: 26942387 RESULT

• Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27.

  PMID: 27131581 RESULT

• Cluver C, Gyte GM, Sinclair M, Dowswell T, Hofmeyr GJ. Interventions for helping to turn term breech babies to head first presentation when using external cephalic version. Cochrane Database Syst Rev. 2015 Feb 9;2015(2):CD000184. doi: 10.1002/14651858.CD000184.pub4.

  PMID: 25674710 RESULT

• Goodman S. Anesthesia for nonobstetric surgery in the pregnant patient. Semin Perinatol. 2002 Apr;26(2):136-45. doi: 10.1053/sper.2002.32203.

  PMID: 12005471 RESULT

• Satomoto M, Satoh Y, Terui K, Miyao H, Takishima K, Ito M, Imaki J. Neonatal exposure to sevoflurane induces abnormal social behaviors and deficits in fear conditioning in mice. Anesthesiology. 2009 Mar;110(3):628-37. doi: 10.1097/ALN.0b013e3181974fa2.

  PMID: 19212262 RESULT

• Song R, Ling X, Peng M, Xue Z, Cang J, Fang F. Maternal Sevoflurane Exposure Causes Abnormal Development of Fetal Prefrontal Cortex and Induces Cognitive Dysfunction in Offspring. Stem Cells Int. 2017;2017:6158468. doi: 10.1155/2017/6158468. Epub 2017 Sep 25.

  PMID: 29098009 RESULT

• Zheng H, Dong Y, Xu Z, Crosby G, Culley DJ, Zhang Y, Xie Z. Sevoflurane anesthesia in pregnant mice induces neurotoxicity in fetal and offspring mice. Anesthesiology. 2013 Mar;118(3):516-26. doi: 10.1097/ALN.0b013e3182834d5d.

  PMID: 23314109 RESULT

• Fok WY, Chan LW, Leung TY, Lau TK. Maternal experience of pain during external cephalic version at term. Acta Obstet Gynecol Scand. 2005 Aug;84(8):748-51. doi: 10.1111/j.0001-6349.2005.00505.x.

  PMID: 16026399 RESULT

• Yildiz K, Dogru K, Dalgic H, Serin IS, Sezer Z, Madenoglu H, Boyaci A. Inhibitory effects of desflurane and sevoflurane on oxytocin-induced contractions of isolated pregnant human myometrium. Acta Anaesthesiol Scand. 2005 Oct;49(9):1355-9. doi: 10.1111/j.1399-6576.2005.00804.x.

  PMID: 16146475 RESULT

• Wang ZH, Yang Y, Xu GP. Remifentanil analgesia during external cephalic version for breech presentation in nulliparous women at term: A randomized controlled trial. Medicine (Baltimore). 2017 Mar;96(11):e6256. doi: 10.1097/MD.0000000000006256.

  PMID: 28296735 RESULT

• Munoz H, Guerra S, Perez-Vaquero P, Valero Martinez C, Aizpuru F, Lopez-Picado A. Remifentanil versus placebo for analgesia during external cephalic version: a randomised clinical trial. Int J Obstet Anesth. 2014 Feb;23(1):52-7. doi: 10.1016/j.ijoa.2013.07.006. Epub 2014 Jan 3.

  PMID: 24388737 RESULT

• Khaw KS, Lee SW, Ngan Kee WD, Law LW, Lau TK, Ng FF, Leung TY. Randomized trial of anaesthetic interventions in external cephalic version for breech presentation. Br J Anaesth. 2015 Jun;114(6):944-50. doi: 10.1093/bja/aev107. Epub 2015 May 10.

  PMID: 25962611 RESULT

• Weiniger CF, Ginosar Y, Elchalal U, Sela HY, Weissman C, Ezra Y. Randomized controlled trial of external cephalic version in term multiparae with or without spinal analgesia. Br J Anaesth. 2010 May;104(5):613-8. doi: 10.1093/bja/aeq053. Epub 2010 Mar 25.

  PMID: 20338954 RESULT

• Chalifoux LA, Bauchat JR, Higgins N, Toledo P, Peralta FM, Farrer J, Gerber SE, McCarthy RJ, Sullivan JT. Effect of Intrathecal Bupivacaine Dose on the Success of External Cephalic Version for Breech Presentation: A Prospective, Randomized, Blinded Clinical Trial. Anesthesiology. 2017 Oct;127(4):625-632. doi: 10.1097/ALN.0000000000001796.

  PMID: 28723831 RESULT

MeSH Terms

Interventions

Sevoflurane

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Adel Alqarni, MD

  King Saud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adel Alqarni, MD

CONTACT

+966540900123; adalqarni@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor and consultant of anesthesia

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: April 15, 2020
• Study Start: May 25, 2020
• Primary Completion: March 31, 2021
• Study Completion: October 30, 2021
• Last Updated: April 24, 2020

Record last verified: 2020-04