Multiple GestationNCT02846129
Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery
An observational study of Multiple Gestation and Cesarean Delivery, run by Mahidol University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Multiple Gestation, Cesarean Delivery, Anesthesia
- How many people
- 1,057 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2016to 20 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pregnant women, multiple gestation e.g. twin, triplet, quadruplet undergoing cesarean section.
Who may be able to join
- Pregnant women, multiple gestation underwent cesarean delivery from the past until 31 Dec 2015
Who cannot join
- Preterm delivery before 24 weeks
- Death fetus in utero
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Anesthesiology department, Siriraj hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery: A Retrospective Review
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.
Read the detailed 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.
- Conditions
- Multiple Gestation, Cesarean Delivery, Anesthesia
- Keywords
- multiple gestation, complications, cesarean delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications associated with anesthesia in multiple gestation undergoing cesarean section
Measured: Up to 24 hours postoperatively
Secondary outcomes (2)
Anesthetic technique used e.g. regional or general anesthesia
Measured: Up to 24 hours postoperatively
Amount of medication used
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startOct 2016
- Primary completion3 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple GestationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,057 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patchareya Nivatpumin, Mahidol University
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02846129
- Sponsor's protocol ID
- 067/2559(EC3)
- Status last verified
- Jul 2017
- First submitted
- 13 Mar 2016
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 23536103Walker 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.
PubMed 15521878Marino 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.
PubMed 11574371Rouse 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.
PubMed 17012451Butwick 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.
PubMed 24907281
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery: A Retrospective Review
- ClinicalTrials.gov ID
- NCT02846129
- Acronym / sponsor ID
- 067/2559(EC3)
- Conditions
- Multiple Gestation, Cesarean Delivery, Anesthesia
- Keywords
- multiple gestation, complications, cesarean delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,057 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women, multiple gestation e.g. twin, triplet, quadruplet undergoing cesarean section.
Key inclusion criteria (1 listed)
- Pregnant women, multiple gestation underwent cesarean delivery from the past until 31 Dec 2015
Key exclusion criteria (2 listed)
- Preterm delivery before 24 weeks
- Death fetus in utero
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of complications associated with anesthesia in multiple gestation undergoing cesarean section
Time frame: Up to 24 hours postoperatively
2 secondary outcomes
Anesthetic technique used e.g. regional or general anesthesia
Time frame: Up to 24 hours postoperatively
Amount of medication used
Time frame: Up to 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Background: PubMed 23536103Trojner-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.
- Background: PubMed 15521878Walker 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.
- Background: PubMed 11574371Marino 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.
- Background: PubMed 17012451Rouse 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.
- Background: PubMed 24907281Butwick 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.
- Individual participant dataSharing planned: Undecided
Related trials for Multiple Gestation
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruitingPhase 1
A Clinical Trial of MK-6916 in Participants With Moderate and Severe Kidney Disease Compared to Healthy Controls (MK-6916-013)
Healthy, Renal Impairment
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patchareya Nivatpumin, M.D. principal investigator
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Gestation and Cesarean Delivery, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications associated with anesthesia in multiple gestation undergoing cesarean section (time frame: Up to 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02846129, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.