MedDataX Logo

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

NCT ID: NCT02846129

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1057 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Gestation Cesarean Delivery Anesthesia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

multiple gestation complications cesarean delivery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Patchareya Nivatpumin

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patchareya Nivatpumin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, , Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 24907281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23536103 (View on PubMed)

Walker MC, Murphy KE, Pan S, Yang Q, Wen SW. Adverse maternal outcomes in multifetal pregnancies. BJOG. 2004 Nov;111(11):1294-6. doi: 10.1111/j.1471-0528.2004.00345.x.

Reference Type BACKGROUND
PMID: 15521878 (View on PubMed)

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. doi: 10.1097/00000539-200110000-00039.

Reference Type BACKGROUND
PMID: 11574371 (View on PubMed)

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. doi: 10.1097/01.AOG.0000236547.35234.8c.

Reference Type BACKGROUND
PMID: 17012451 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

067/2559(EC3)

Identifier Type: -

Identifier Source: org_study_id