Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery

Anesthesia Clinical Trial

Official title:

Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery: A Retrospective Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846129
• Other study ID #: 067/2559(EC3)
• Status: Completed
• Phase: N/A
• First received: March 13, 2016
• Last updated: July 28, 2017
• Start date: October 2016
• Est. completion date: July 20, 2017

Study information

• Verified date: July 2017
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Incidence of anesthesia related complications in multiple gestation patients undergoing cesarean delivery has not been reported in Thailand. The aim of this study is to identify complications that occur which may derived from different anesthetic techniques used, such as hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood transfusion and fetal outcome.

Description:

Nowadays, the rate of multiple gestations is increasing considerably due to the prevalence of assisted reproductive technology. As physiologic changes from multiple gestations differ from singleton pregnancy, multiple gestations are considered a high risk pregnancy. A number of complications can occur from prenatal period such as preterm labor and increase rate of maternal beta agonist usage e.g. ritodrine, terbutaline and salbutamol. These drugs cause maternal tachycardia, hypokalemia and pulmonary edema. Multiple gestations increase rate of cesarean delivery and intraoperative complications such as postpartum hemorrhage and hysterectomy can be found 3.7 times and 2.3 times respectively higher than that of singleton pregnancy.

Spinal anesthesia is the anesthetic technique of choice for parturients undergoing cesarean section, owing to its rapid onset of action, reliability, superior postoperative pain control and lower mortality rate than general anesthesia. However, the most important complication is maternal hypotension, especially in multiple gestations that may derive from more aortocaval compression comparing with singleton pregnancy. Nevertheless, some patients having contraindications for regional anesthesia e.g. thrombocytopenia, coagulopathy or pulmonary edema make anesthesiologists decide to put these patients under general anesthesia for cesarean section. General anesthesia for cesarean section in singleton pregnancy has been proved that can cause higher incidence of postpartum hemorrhage and higher rate of blood transfusion compared to regional anesthesia.

Incidence of anesthesia related complications in multiple gestation patients undergoing cesarean delivery has not been reported in Thailand. The aim of this study is to identify complications that occur which may derived from different anesthetic techniques used, such as hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood transfusion and fetal outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1057
• Est. completion date: July 20, 2017
• Est. primary completion date: July 3, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women, multiple gestation underwent cesarean delivery from the past until 31 Dec 2015

Exclusion Criteria:

• Preterm delivery before 24 weeks

• Death fetus in utero

Related Conditions & MeSH terms

• Anesthesia
• Cesarean Delivery
• Multiple Gestation

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (5)

Butwick AJ, Carvalho B, El-Sayed YY. Risk factors for obstetric morbidity in patients with uterine atony undergoing caesarean delivery. Br J Anaesth. 2014 Oct;113(4):661-8. doi: 10.1093/bja/aeu150. Epub 2014 Jun 6. — View Citation

Marino T, Goudas LC, Steinbok V, Craigo SD, Yarnell RW. The anesthetic management of triplet cesarean delivery: a retrospective case series of maternal outcomes. Anesth Analg. 2001 Oct;93(4):991-5. — View Citation

Rouse DJ, MacPherson C, Landon M, Varner MW, Leveno KJ, Moawad AH, Spong CY, Caritis SN, Meis PJ, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai BM, Langer O, Thorp JM, Ramin SM, Mercer BM; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Blood transfusion and cesarean delivery. Obstet Gynecol. 2006 Oct;108(4):891-7. Erratum in: Obstet Gynecol. 2006 Dec;108(6):1556. — View Citation

Trojner-Bregar A, Tul N, Verdenik I, Novak Z, Blickstein I. Puerperal morbidity following repeat cesarean delivery in twin pregnancies. Arch Gynecol Obstet. 2013 Sep;288(3):551-4. doi: 10.1007/s00404-013-2818-8. Epub 2013 Mar 28. — View Citation

Walker MC, Murphy KE, Pan S, Yang Q, Wen SW. Adverse maternal outcomes in multifetal pregnancies. BJOG. 2004 Nov;111(11):1294-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of complications associated with anesthesia in multiple gestation undergoing cesarean section		Up to 24 hours postoperatively
Secondary	Anesthetic technique used e.g. regional or general anesthesia		Up to 24 hours postoperatively
Secondary	Amount of medication used		Up to 24 hours postoperatively