Caesarian SectionNCT03054233
Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women
A study testing Crossed leg sitting position in people with Caesarian Section, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Caesarian Section
- What is being tested?
- Crossed leg sitting position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesIndonesia
- Study dates
- Jul 2016to Dec 2016
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged 18-45 years old, with American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo caesarian section with spinal anesthesia in crossed leg sitting position.
- Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form
Who cannot join
- Subjects with contraindications for spinal anesthesia
- Subjects with fetal's head trapped, umbilical prolapse, and foot presentation
- Subjects with pre-eclampsia
- Subjects with cardiovascular diseases
- Subjects with scoliosis
- Subjects with recent lumbal surgery history
Show all 12Show fewer
- Subjects who cannot sit in crossed leg sitting position.
- Drop out criteria:
- Subjects with worsening conditions before spinal anesthesia
- Subjects with failed spinal needle insertion and thus received general anesthesia
- Subjects with twin pregnancy
- Subjects drop out the study.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
Cipto Mangunkusumo Central National Hospital
Central Jakarta, DKI Jakarta, 10430
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women in Crossed Leg Sitting Position Undergoing Caesarean Section
The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section
Read the detailed description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study.Subjects sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. The back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.
- Conditions
- Caesarian Section
- Being tested
- Crossed leg sitting position
- Keywords
- spinal anesthesia, spinal-bone contact, caesarian section, crossed leg sitting position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crossed leg sitting positionProcedure or surgery
Spinal anesthesia done in crossed leg sitting position
| Study group | Role | What they receive |
|---|---|---|
| Obese | Experimental | Obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section Receives: Procedure: Crossed leg sitting position |
| Non-obese | Experimental | Non-obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section Receives: Procedure: Crossed leg sitting position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of successful spinal needle placement in the first attempt
The number of successful spinal needle placement in the first attempt was recorded in yes/no method.
Measured: 2 months
The number of needle-bone contact
The number of spinal needle-bone contact
Measured: 2 months
Secondary outcomes (1)
The number of blood vessel puncture incidence.
The number of blood vessel puncture incidence by the spinal needle during insertion.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startJul 2016
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Caesarian SectionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susilo Chandra, Universitas Indonesia
- Investigators
- Susilo Chandra, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054233
- Sponsor's protocol ID
- IndonesiaUAnes010
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2017
- Last updated
- 16 Feb 2017
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Davies GA, Maxwell C, McLeod L, Gagnon R, Basso M, Bos H, Delisle MF, Farine D, Hudon L, Menticoglou S, Mundle W, Murphy-Kaulbeck L, Ouellet A, Pressey T, Roggensack A, Leduc D, Ballerman C, Biringer A, Duperron L, Jones D, Lee LS, Shepherd D, Wilson K; Society of Obstetricians and Gynaecologists of Canada. SOGC Clinical Practice Guidelines: Obesity in pregnancy. No. 239, February 2010. Int J Gynaecol Obstet. 2010 Aug;110(2):167-73. doi: 10.1016/j.ijgo.2010.03.008.
PubMed 20641146American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 549: obesity in pregnancy. Obstet Gynecol. 2013 Jan;121(1):213-7. doi: 10.1097/01.aog.0000425667.10377.60.
PubMed 23262963Rodrigues FR, Brandao MJ. Regional anesthesia for cesarean section in obese pregnant women: a retrospective study. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):13-20. doi: 10.1016/S0034-7094(11)70002-2.
PubMed 21334503Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.
PubMed 24790901Watanabe S, Kobara K, Ishida H, Eguchi A. Influence of trunk muscle co-contraction on spinal curvature during sitting cross-legged. Electromyogr Clin Neurophysiol. 2010 Apr-Jun;50(3-4):187-92.
PubMed 20552952Sebire NJ, Jolly M, Harris JP, Wadsworth J, Joffe M, Beard RW, Regan L, Robinson S. Maternal obesity and pregnancy outcome: a study of 287,213 pregnancies in London. Int J Obes Relat Metab Disord. 2001 Aug;25(8):1175-82. doi: 10.1038/sj.ijo.0801670.
PubMed 11477502Mhyre JM. Anesthetic management for the morbidly obese pregnant woman. Int Anesthesiol Clin. 2007 Winter;45(1):51-70. doi: 10.1097/AIA.0b013e31802b8a90. No abstract available.
PubMed 17215699Vricella LK, Louis JM, Mercer BM, Bolden N. Anesthesia complications during scheduled cesarean delivery for morbidly obese women. Am J Obstet Gynecol. 2010 Sep;203(3):276.e1-5. doi: 10.1016/j.ajog.2010.06.022. Epub 2010 Jul 31.
PubMed 20673866Broadbent CR, Maxwell WB, Ferrie R, Wilson DJ, Gawne-Cain M, Russell R. Ability of anaesthetists to identify a marked lumbar interspace. Anaesthesia. 2000 Nov;55(11):1122-6. doi: 10.1046/j.1365-2044.2000.01547-4.x.
PubMed 11069342Gulay U, Meltem T, Nadir SS, Aysin A. Ultrasound-guided evaluation of the lumbar subarachnoid space in lateral and sitting positions in pregnant patients to receive elective cesarean operation. Pak J Med Sci. 2015 Jan-Feb;31(1):76-81. doi: 10.12669/pjms.311.5647.
PubMed 25878618Kim SH, Kim DY, Han JI, Baik HJ, Park HS, Lee GY, Kim JH. Vertebral level of Tuffier's line measured by ultrasonography in parturients in the lateral decubitus position. Korean J Anesthesiol. 2014 Sep;67(3):181-5. doi: 10.4097/kjae.2014.67.3.181. Epub 2014 Sep 24.
PubMed 25302094Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
PubMed 19809292Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.
PubMed 15527629Cadi P, Guenoun T, Journois D, Chevallier JM, Diehl JL, Safran D. Pressure-controlled ventilation improves oxygenation during laparoscopic obesity surgery compared with volume-controlled ventilation. Br J Anaesth. 2008 May;100(5):709-16. doi: 10.1093/bja/aen067.
PubMed 18407943McKay RE, Malhotra A, Cakmakkaya OS, Hall KT, McKay WR, Apfel CC. Effect of increased body mass index and anaesthetic duration on recovery of protective airway reflexes after sevoflurane vs desflurane. Br J Anaesth. 2010 Feb;104(2):175-82. doi: 10.1093/bja/aep374. Epub 2009 Dec 26.
PubMed 20037150
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women in Crossed Leg Sitting Position Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT03054233
- Acronym / sponsor ID
- IndonesiaUAnes010
- Conditions
- Caesarian Section
- Keywords
- spinal anesthesia, spinal-bone contact, caesarian section, crossed leg sitting position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Feb 2017 (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.
The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section
Detailed description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study.Subjects sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. The back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | Experimental | Procedure: Crossed leg sitting positionObese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section |
| Non-obese | Experimental | Procedure: Crossed leg sitting positionNon-obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects aged 18-45 years old, with American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo caesarian section with spinal anesthesia in crossed leg sitting position.
- Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form
Key exclusion criteria (12 listed)
- Subjects with contraindications for spinal anesthesia
- Subjects with fetal's head trapped, umbilical prolapse, and foot presentation
- Subjects with pre-eclampsia
- Subjects with cardiovascular diseases
- Subjects with scoliosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crossed leg sitting positionSpinal anesthesia done in crossed leg sitting position | Procedure or surgery | Non-obese, Obese |
Primary outcome
Number of successful spinal needle placement in the first attempt
Time frame: 2 months
The number of successful spinal needle placement in the first attempt was recorded in yes/no method.
The number of needle-bone contact
Time frame: 2 months
The number of spinal needle-bone contact
1 secondary outcome
The number of blood vessel puncture incidence.
Time frame: 2 months
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 16 Feb 2017.
- Background: PubMed 20641146Davies GA, Maxwell C, McLeod L, Gagnon R, Basso M, Bos H, Delisle MF, Farine D, Hudon L, Menticoglou S, Mundle W, Murphy-Kaulbeck L, Ouellet A, Pressey T, Roggensack A, Leduc D, Ballerman C, Biringer A, Duperron L, Jones D, Lee LS, Shepherd D, Wilson K; Society of Obstetricians and Gynaecologists of Canada. SOGC Clinical Practice Guidelines: Obesity in pregnancy. No. 239, February 2010. Int J Gynaecol Obstet. 2010 Aug;110(2):167-73. doi: 10.1016/j.ijgo.2010.03.008.
- Background: PubMed 23262963American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 549: obesity in pregnancy. Obstet Gynecol. 2013 Jan;121(1):213-7. doi: 10.1097/01.aog.0000425667.10377.60.
- Background: PubMed 21334503Rodrigues FR, Brandao MJ. Regional anesthesia for cesarean section in obese pregnant women: a retrospective study. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):13-20. doi: 10.1016/S0034-7094(11)70002-2.
- Background: PubMed 24790901Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.
- Background: PubMed 20552952Watanabe S, Kobara K, Ishida H, Eguchi A. Influence of trunk muscle co-contraction on spinal curvature during sitting cross-legged. Electromyogr Clin Neurophysiol. 2010 Apr-Jun;50(3-4):187-92.
- Background: PubMed 11477502Sebire NJ, Jolly M, Harris JP, Wadsworth J, Joffe M, Beard RW, Regan L, Robinson S. Maternal obesity and pregnancy outcome: a study of 287,213 pregnancies in London. Int J Obes Relat Metab Disord. 2001 Aug;25(8):1175-82. doi: 10.1038/sj.ijo.0801670.
- Background: PubMed 17215699Mhyre JM. Anesthetic management for the morbidly obese pregnant woman. Int Anesthesiol Clin. 2007 Winter;45(1):51-70. doi: 10.1097/AIA.0b013e31802b8a90. No abstract available.
- Background: PubMed 20673866Vricella LK, Louis JM, Mercer BM, Bolden N. Anesthesia complications during scheduled cesarean delivery for morbidly obese women. Am J Obstet Gynecol. 2010 Sep;203(3):276.e1-5. doi: 10.1016/j.ajog.2010.06.022. Epub 2010 Jul 31.
- Background: PubMed 11069342Broadbent CR, Maxwell WB, Ferrie R, Wilson DJ, Gawne-Cain M, Russell R. Ability of anaesthetists to identify a marked lumbar interspace. Anaesthesia. 2000 Nov;55(11):1122-6. doi: 10.1046/j.1365-2044.2000.01547-4.x.
- Background: PubMed 25878618Gulay U, Meltem T, Nadir SS, Aysin A. Ultrasound-guided evaluation of the lumbar subarachnoid space in lateral and sitting positions in pregnant patients to receive elective cesarean operation. Pak J Med Sci. 2015 Jan-Feb;31(1):76-81. doi: 10.12669/pjms.311.5647.
- Background: PubMed 25302094Kim SH, Kim DY, Han JI, Baik HJ, Park HS, Lee GY, Kim JH. Vertebral level of Tuffier's line measured by ultrasonography in parturients in the lateral decubitus position. Korean J Anesthesiol. 2014 Sep;67(3):181-5. doi: 10.4097/kjae.2014.67.3.181. Epub 2014 Sep 24.
- Background: PubMed 19809292Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.
- Individual participant dataSharing planned: Undecided
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.
Susilo Chandra principal investigator
Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crossed leg sitting position in people with Caesarian Section, run by Universitas Indonesia at 2 sites in Indonesia.
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 2 inclusion and 12 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 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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?
Number of successful spinal needle placement in the first attempt (time frame: 2 months). The study lists 2 primary outcomes in all. 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 NCT03054233, which also lists 16 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 16 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.