HypotensionNCT04692870
Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non- Elective Caesarean Section
An observational study of Hypotension, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
Trial summary
This is a prospective observational study done in parturient planned for non-elective caesarean section. Association between shock index (HR/SBP) and post-spinal hypotension in parturient undergoing non-elective caesarean section will be evaluated in this research. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypotension
- How many people
- 337 participants
- Where
- 1 siteNepal
- Study dates
- 6 Jan 2021to 25 Feb 2022
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients at term undergoing emergency caesarean delivery and falling under category 2 (no immediate threat to life of pregnant women and fetus) and category 3 (requiring early delivery) according to NICE (National Institute for Clinical Excellence) guideline classification of urgency of emergency caesarean section and ASA (American society of Anaesthesiologist) PS (Physical status) grade II under spinal anesthesia will be included.
Who may be able to join
- All parturient at term (gestational weeks ≥ 37)
- ASA (American society of Anesthesiologist) PS (Physical status) grade II
- Category 2 and 3 of non-elective caesarean section
Who cannot join
- ASA PS Grade >2
- Pregnancy induced hypertension
- Gestational hypertension
- Known fetal abnormalities
- Contraindications to spinal anesthesia
- Multiple pregnancy
Show all 15Show fewer
- Baseline SBP< 100 mmHg
- Intrauterine growth restriction (IUGR)
- Missing height and/ or weight data
- Stillbirth
- Height: <150 cm
- Ante-partum hemorrhage
- Cardiovascular, cerebrovascular disease, endocrine disease
- Gestational diabetes
- Failed spinal anesthesia requiring GA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non-elective Caesarean Section: A Prospective Observational Study
This is a prospective observational study done in parturient planned for non-elective caesarean section. Association between shock index (HR/SBP) and post-spinal hypotension in parturient undergoing non-elective caesarean section will be evaluated in this research.
Read the detailed description
Studies have shown that early hypovolemia is insufficient to produce changes in orthostatic heart rate (HR) or systolic blood pressure (SBP). Studies have shown that Shock Index (SI) as a useful indicator for acute hypovolemia. In healthy individuals, acute blood loss less than 450 mL rarely produces abnormal HR or SBP. As, several studies have shown that relationship of baseline heart rate and systolic blood pressure in predicting post spinal hypotension, this study aims to incorporate both the parameters and attempt to develop a single effective predictor for post spinal hypotension in the form of SI.
Methodology After approval from Institutional Review committee of B.P. Koirala Institute of Health Sciences, parturient undergoing non-elective caesarian of ASA PS grade II and urgency category 2 and 3, fulfilling the inclusion criteria will be informed about the study and written consent will be obtained either in labour room or in obstetric emergency ward. During this visit patient's data that includes age, indication of caesarean section, preoperative anxiety (APAIS), gestational age, and duration of fasting, height, weight, BMI and preoperative hemoglobin concentration will be recorded.
The study will be conducted in accordance with the ethical principles of the 1964 Declaration of Helsinki and STROBE (Strengthening the Reporting of Observational studies in Epidemiology) guidelines will be followed. Before patient is shifted to the operating room (OR), ranitidine 50 mg and metoclopramide 10 mg will be administered intravenously via 18 G cannula. The patient will be shifted to operating table and standard monitors 3 lead ECG, pulse oximetry and noninvasive blood pressure will be attached. Baseline vital signs heart rate and noninvasive SBP will be recorded in operation theatre in supine position with 15° left lateral tilt before administering spinal anaesthesia. NIBP will be measured by using cuff size with width of cuff bladder covering at least 40% of arm circumference and length at least 80% and will be measured from EDAN elite V8 monitors. 3 measurements of SBP will be recorded at 1 minute interval and its mean value will be taken as baseline SBP.
Also, shock index (HR/ SBP) will be calculated before administering spinal anaesthesia. At every 1 minute interval until delivery of baby, vitals parameters HR, SBP and MAP will be measured and shock index will be calculated in each time interval. Then, the patient will be placed in sitting position. Under all aseptic precautions, 2.2 ml of 0.5% hyperbaric bupivacaine with 10 µg fentanyl will be administered in sitting position in L4- L5 or L3- L4 interspace after confirmation of free flow of CSF with 25 G Quincke's needle and drug will be injected over 20 secs. Patient will be then immediately put into supine position with a right hip wedge. A 1 L co-loading of Ringer's lactate will be administered rapidly within 10 minutes via an 18 G intravenous line after administering spinal anaesthesia. Phenylepinephrine infusion will be started at 25 microgram/min immediately after the spinal injection. The sensory level of anaesthesia will be checked using loss of cold sensation with the use of alcohol soaked cotton swabs every minute until 20 mins. Surgery will be allowed once the bilateral sensory block height at T6 is achieved. Oxygen at 40% will be administered via nasal cannula at 2-4 L/min until delivery.
Hemodynamic parameters will be recorded at following time intervals: baseline, immediately after spinal anaesthesia, every minute for the first 15 minutes after spinal injection and every 2.5 mins until end of surgery. Hypotension will be treated with phenylephrine 50 µg bolus and rapid infusion of Ringer's lactate 200 ml. If bradycardia (HR< 55/min) is associated with hypotension, IV ephedrine 6 mg will be administered. If these measures fail and bradycardia is still persistent then an IV atropine 0.5 mg will be given. Intraoperative hypertension (defined as SBP greater than 120% of the baseline reading) will be managed by stopping norepinephrine infusion. The infusion will be resumed when blood pressure returns to the upper limit of the target range i.e. 20% above baseline.After delivery of the baby, 3 IU of oxytocin will be administered IV over ≥ 30 sec followed by an infusion of 10 IU/hr (oxytocin 40 IU in 500 ml of Hartmann's solution).
The total amount of intraoperative IV fluids administered and estimated blood loss will be measured. At the conclusion of the surgery, blood loss will be estimated by cumulative measurement of the following: the volume of blood in the suction canister (and subtracting the estimated amniotic fluid from the suction chamber); visual examination of the surgical sponges.
Intraoperative use of other uterotonic agent or blood transfusion will be recorded. The attending pediatrician will assess neonatal Apgar scores at 1 and 5 minutes after delivery.
Patients will be asked to report the occurrence of intraoperative nausea Incidence of intraoperative pruritus, shivering, and dizziness will also be recorded.
The primary outcome measures will be incidence of post spinal hypotension defined as SBP < 80% of baseline reading or SBP < 100 mmHg after administering of spinal anaesthesia until delivery of baby. The secondary outcome measures will be post-delivery hypotension is defined as SBP < 80% of baseline reading or SBP < 100 mmHg observed from starting oxytocin until end of surgery.
Data collection Baseline data (gestational age, preoperative hemoglobin, preoperative anxiety, uterine incision to delivery time, hemodynamic parameters) and outcome parameters will be collected in the paper case record form and entered in windows Microsoft excel spreadsheet and will use STATA version 15.0 for analysis.
- Conditions
- Hypotension
- Keywords
- cesarean section, hypotension, spinal anesthesia, shock index, post spinal hypotension, non-elective cesarean section
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post spinal hypotension
SBP < 80% of baseline reading or SBP < 100 mmHg after administering spinal anesthesia
Measured: time points between administering spinal anesthesia and until delivery of baby before starting oxytocin during surgery
Secondary outcomes (1)
post-delivery hypotension
< 80% of baseline reading or SBP < 100 mmHg observed
Measured: During surgery from starting oxytocin after delivery of baby until the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start6 Jan 2021
- Primary completion15 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirish Silwal, B.P. Koirala Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692870
- Sponsor's protocol ID
- IRC/ 1872/ 020
- Status last verified
- Mar 2022
- First submitted
- 26 Dec 2020
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yentis SM, Richards NA. Classification of urgency of caesarean section. Obstet Gynaecol Reprod Med. 2008;18(5):139-40
Kamat LL, Jha TR, Talnikar AS, Mahevi ZM, Save MP. Effect of Ondansetron in Attenuation of Post - Spinal Hypotension in Caesarean Section : A Comparison of Two Different Doses with Placebo. J Obstet Anaesth Crit Care 2017; 7 (2):69-74
Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.
PubMed 31531852Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.
PubMed 22100822Tang L, Tang L, Li S, Huang S, Chen L, Zhang J. Spinal anaesthesia for emergency caesarean section better using 25-gauge pencil point needle or 22-gauge cutting needle: a single centre prospective study. International Journal of research in medical sciences, 2017;10(8):12293-12300
Somboonviboon W, Kyokong O, Charuluxananan S, Narasethakamol A. Incidence and risk factors of hypotension and bradycardia after spinal anesthesia for cesarean section. J Med Assoc Thai. 2008 Feb;91(2):181-7.
PubMed 18389982Ngan Kee WD, Khaw KS, Lau TK, Ng FF, Chui K, Ng KL. Randomised double-blinded comparison of phenylephrine vs ephedrine for maintaining blood pressure during spinal anaesthesia for non-elective Caesarean section*. Anaesthesia. 2008 Dec;63(12):1319-26. doi: 10.1111/j.1365-2044.2008.05635.x.
PubMed 19032300Sklebar I, Bujas T, Habek D. SPINAL ANAESTHESIA-INDUCED HYPOTENSION IN OBSTETRICS: PREVENTION AND THERAPY. Acta Clin Croat. 2019 Jun;58(Suppl 1):90-95. doi: 10.20471/acc.2019.58.s1.13.
PubMed 31741565Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003 Jul;97(1):256-8, table of contents. doi: 10.1213/01.ane.0000067400.79654.30.
PubMed 12818977Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003 May;98(5):1250-60. doi: 10.1097/00000542-200305000-00030. No abstract available.
PubMed 12717149McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. doi: 10.1093/bja/70.6.672.
PubMed 8329261Bishop DG, Cairns C, Grobbelaar M, Rodseth RN. Obstetric spinal hypotension: Preoperative risk factors and the development of a preliminary risk score - the PRAM score. S Afr Med J. 2017 Nov 27;107(12):1127-1131. doi: 10.7196/SAMJ.2017.v107i12.12390.
PubMed 29262969Butwick AJ, Columb MO, Carvalho B. Preventing spinal hypotension during Caesarean delivery: what is the latest? Br J Anaesth. 2015 Feb;114(2):183-6. doi: 10.1093/bja/aeu267. Epub 2014 Jul 30. No abstract available.
PubMed 25080429Saravanan S, Kocarev M, Wilson RC, Watkins E, Columb MO, Lyons G. Equivalent dose of ephedrine and phenylephrine in the prevention of post-spinal hypotension in Caesarean section. Br J Anaesth. 2006 Jan;96(1):95-9. doi: 10.1093/bja/aei265. Epub 2005 Nov 25.
PubMed 16311286Adıyeke E. Is the Emergency Cesarean Section associated with Hypotension ? Retrospective Analysis of 80 Patients Undergoing Elective or Emergency Cesarean Section under Spinal Anesthesia. Haydarpasa Numune Medical Journal 2019;59(4):342-346
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Shock Index and Hypotension After Spinal Anaesthesia for Non-elective Caesarean Section: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04692870
- Acronym / sponsor ID
- IRC/ 1872/ 020
- Conditions
- Hypotension
- Keywords
- cesarean section, hypotension, spinal anesthesia, shock index, post spinal hypotension, non-elective cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 5 Jan 2021 (actual)
- 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.
This is a prospective observational study done in parturient planned for non-elective caesarean section. Association between shock index (HR/SBP) and post-spinal hypotension in parturient undergoing non-elective caesarean section will be evaluated in this research.
Detailed description
Studies have shown that early hypovolemia is insufficient to produce changes in orthostatic heart rate (HR) or systolic blood pressure (SBP). Studies have shown that Shock Index (SI) as a useful indicator for acute hypovolemia. In healthy individuals, acute blood loss less than 450 mL rarely produces abnormal HR or SBP. As, several studies have shown that relationship of baseline heart rate and systolic blood pressure in predicting post spinal hypotension, this study aims to incorporate both the parameters and attempt to develop a single effective predictor for post spinal hypotension in the form of SI.
Methodology After approval from Institutional Review committee of B.P. Koirala Institute of Health Sciences, parturient undergoing non-elective caesarian of ASA PS grade II and urgency category 2 and 3, fulfilling the inclusion criteria will be informed about the study and written consent will be obtained either in labour room or in obstetric emergency ward. During this visit patient's data that includes age, indication of caesarean section, preoperative anxiety (APAIS), gestational age, and duration of fasting, height, weight, BMI and preoperative hemoglobin concentration will be recorded.
The study will be conducted in accordance with the ethical principles of the 1964 Declaration of Helsinki and STROBE (Strengthening the Reporting of Observational studies in Epidemiology) guidelines will be followed. Before patient is shifted to the operating room (OR), ranitidine 50 mg and metoclopramide 10 mg will be administered intravenously via 18 G cannula. The patient will be shifted to operating table and standard monitors 3 lead ECG, pulse oximetry and noninvasive blood pressure will be attached. Baseline vital signs heart rate and noninvasive SBP will be recorded in operation theatre in supine position with 15° left lateral tilt before administering spinal anaesthesia. NIBP will be measured by using cuff size with width of cuff bladder covering at least 40% of arm circumference and length at least 80% and will be measured from EDAN elite V8 monitors. 3 measurements of SBP will be recorded at 1 minute interval and its mean value will be taken as baseline SBP.
Also, shock index (HR/ SBP) will be calculated before administering spinal anaesthesia. At every 1 minute interval until delivery of baby, vitals parameters HR, SBP and MAP will be measured and shock index will be calculated in each time interval. Then, the patient will be placed in sitting position. Under all aseptic precautions, 2.2 ml of 0.5% hyperbaric bupivacaine with 10 µg fentanyl will be administered in sitting position in L4- L5 or L3- L4 interspace after confirmation of free flow of CSF with 25 G Quincke's needle and drug will be injected over 20 secs. Patient will be then immediately put into supine position with a right hip wedge. A 1 L co-loading of Ringer's lactate will be administered rapidly within 10 minutes via an 18 G intravenous line after administering spinal anaesthesia. Phenylepinephrine infusion will be started at 25 microgram/min immediately after the spinal injection. The sensory level of anaesthesia will be checked using loss of cold sensation with the use of alcohol soaked cotton swabs every minute until 20 mins. Surgery will be allowed once the bilateral sensory block height at T6 is achieved. Oxygen at 40% will be administered via nasal cannula at 2-4 L/min until delivery.
Hemodynamic parameters will be recorded at following time intervals: baseline, immediately after spinal anaesthesia, every minute for the first 15 minutes after spinal injection and every 2.5 mins until end of surgery. Hypotension will be treated with phenylephrine 50 µg bolus and rapid infusion of Ringer's lactate 200 ml. If bradycardia (HR< 55/min) is associated with hypotension, IV ephedrine 6 mg will be administered. If these measures fail and bradycardia is still persistent then an IV atropine 0.5 mg will be given. Intraoperative hypertension (defined as SBP greater than 120% of the baseline reading) will be managed by stopping norepinephrine infusion. The infusion will be resumed when blood pressure returns to the upper limit of the target range i.e. 20% above baseline.After delivery of the baby, 3 IU of oxytocin will be administered IV over ≥ 30 sec followed by an infusion of 10 IU/hr (oxytocin 40 IU in 500 ml of Hartmann's solution).
The total amount of intraoperative IV fluids administered and estimated blood loss will be measured. At the conclusion of the surgery, blood loss will be estimated by cumulative measurement of the following: the volume of blood in the suction canister (and subtracting the estimated amniotic fluid from the suction chamber); visual examination of the surgical sponges.
Intraoperative use of other uterotonic agent or blood transfusion will be recorded. The attending pediatrician will assess neonatal Apgar scores at 1 and 5 minutes after delivery.
Patients will be asked to report the occurrence of intraoperative nausea Incidence of intraoperative pruritus, shivering, and dizziness will also be recorded.
The primary outcome measures will be incidence of post spinal hypotension defined as SBP < 80% of baseline reading or SBP < 100 mmHg after administering of spinal anaesthesia until delivery of baby. The secondary outcome measures will be post-delivery hypotension is defined as SBP < 80% of baseline reading or SBP < 100 mmHg observed from starting oxytocin until end of surgery.
Data collection Baseline data (gestational age, preoperative hemoglobin, preoperative anxiety, uterine incision to delivery time, hemodynamic parameters) and outcome parameters will be collected in the paper case record form and entered in windows Microsoft excel spreadsheet and will use STATA version 15.0 for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients at term undergoing emergency caesarean delivery and falling under category 2 (no immediate threat to life of pregnant women and fetus) and category 3 (requiring early delivery) according to NICE (National Institute for Clinical Excellence) guideline classification of urgency of emergency caesarean section and ASA (American society of Anaesthesiologist) PS (Physical status) grade II under spinal anesthesia will be included.
Key inclusion criteria (3 listed)
- All parturient at term (gestational weeks ≥ 37)
- ASA (American society of Anesthesiologist) PS (Physical status) grade II
- Category 2 and 3 of non-elective caesarean section
Key exclusion criteria (15 listed)
- ASA PS Grade >2
- Pregnancy induced hypertension
- Gestational hypertension
- Known fetal abnormalities
- Contraindications to spinal anesthesia
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 post spinal hypotension
Time frame: time points between administering spinal anesthesia and until delivery of baby before starting oxytocin during surgery
SBP < 80% of baseline reading or SBP < 100 mmHg after administering spinal anesthesia
1 secondary outcome
post-delivery hypotension
Time frame: During surgery from starting oxytocin after delivery of baby until the end of surgery
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 14 Mar 2022.
- BackgroundYentis SM, Richards NA. Classification of urgency of caesarean section. Obstet Gynaecol Reprod Med. 2008;18(5):139-40
- BackgroundKamat LL, Jha TR, Talnikar AS, Mahevi ZM, Save MP. Effect of Ondansetron in Attenuation of Post - Spinal Hypotension in Caesarean Section : A Comparison of Two Different Doses with Placebo. J Obstet Anaesth Crit Care 2017; 7 (2):69-74
- Background: PubMed 31531852Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.
- Background: PubMed 22100822Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.
- BackgroundTang L, Tang L, Li S, Huang S, Chen L, Zhang J. Spinal anaesthesia for emergency caesarean section better using 25-gauge pencil point needle or 22-gauge cutting needle: a single centre prospective study. International Journal of research in medical sciences, 2017;10(8):12293-12300
- Background: PubMed 18389982Somboonviboon W, Kyokong O, Charuluxananan S, Narasethakamol A. Incidence and risk factors of hypotension and bradycardia after spinal anesthesia for cesarean section. J Med Assoc Thai. 2008 Feb;91(2):181-7.
- Background: PubMed 19032300Ngan Kee WD, Khaw KS, Lau TK, Ng FF, Chui K, Ng KL. Randomised double-blinded comparison of phenylephrine vs ephedrine for maintaining blood pressure during spinal anaesthesia for non-elective Caesarean section*. Anaesthesia. 2008 Dec;63(12):1319-26. doi: 10.1111/j.1365-2044.2008.05635.x.
- Background: PubMed 31741565Sklebar I, Bujas T, Habek D. SPINAL ANAESTHESIA-INDUCED HYPOTENSION IN OBSTETRICS: PREVENTION AND THERAPY. Acta Clin Croat. 2019 Jun;58(Suppl 1):90-95. doi: 10.20471/acc.2019.58.s1.13.
- Background: PubMed 12818977Bamber JH, Dresner M. Aortocaval compression in pregnancy: the effect of changing the degree and direction of lateral tilt on maternal cardiac output. Anesth Analg. 2003 Jul;97(1):256-8, table of contents. doi: 10.1213/01.ane.0000067400.79654.30.
- Background: PubMed 12717149Campagna JA, Carter C. Clinical relevance of the Bezold-Jarisch reflex. Anesthesiology. 2003 May;98(5):1250-60. doi: 10.1097/00000542-200305000-00030. No abstract available.
- Background: PubMed 8329261McCrae AF, Wildsmith JA. Prevention and treatment of hypotension during central neural block. Br J Anaesth. 1993 Jun;70(6):672-80. doi: 10.1093/bja/70.6.672.
- Background: PubMed 29262969Bishop DG, Cairns C, Grobbelaar M, Rodseth RN. Obstetric spinal hypotension: Preoperative risk factors and the development of a preliminary risk score - the PRAM score. S Afr Med J. 2017 Nov 27;107(12):1127-1131. doi: 10.7196/SAMJ.2017.v107i12.12390.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypotension, run by B.P. Koirala Institute of Health Sciences at 1 site in Nepal.
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 3 inclusion and 15 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 14 Mar 2022. 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 Nepal. 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 post spinal hypotension (time frame: time points between administering spinal anesthesia and until delivery of baby before starting oxytocin during surgery). 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 NCT04692870, which also lists 45 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 14 Mar 2022.