Cesarean SectionVOHOCUNANCT01013090
Fluid Volume-hypotension Association in Cesarean Under Neuraxial Anesthesia
A study testing Ringer's Lactate and Six percent hydroxyethyl starch in people with Cesarean Section, run by Nanjing Medical University at 1 site in China.
Trial summary
Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Ringer's Lactate and Six percent hydroxyethyl starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jul 2009to Dec 2009
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 21-40 yr
- First time of delivery
- ASA status I-II
- No premature
- No genetic and infectious diseases
- Chinese
Who cannot join
- < 21 yr
- > 40 yr
- Subjects with cardiac and pulmonary disorders
- Dislocation of placenta
- Pregnant hypertension
- Allergy to local anesthetics
Show all 10Show fewer
- Unwilling to cooperation
- Need intraoperative administration of vascular active agents
- With significant delivery side effects
- With contradictions of neuraxial anesthesia
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia
Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.
- Conditions
- Cesarean Section
- Being tested
- Ringer's Lactate, Six percent hydroxyethyl starch
- Keywords
- Epidural anesthesia, Spinal anesthesia, Combined spinal-epidural anesthesia, Fluid therapy, Crystalloid, Colloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's LactateDrug
Also called Lactated Ringer's solution
Ringer's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
Six percent hydroxyethyl starchDrug
Also called HES/HAES
Six percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks
| Study group | Role | What they receive |
|---|---|---|
| Epidural crystalloid | Active comparator | Crystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section Receives: Drug: Ringer's Lactate |
| Epidural colloid | Active comparator | Colloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section Receives: Drug: Six percent hydroxyethyl starch |
| Spinal crystalloid | Active comparator | Crystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section Receives: Drug: Ringer's Lactate |
| Spinal colloid | Active comparator | Colloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section Receives: Drug: Six percent hydroxyethyl starch |
| CSEA crystalloid | Active comparator | Crystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section Receives: Drug: Ringer's Lactate |
| CSEA colloid | Active comparator | Colloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section Receives: Drug: Six percent hydroxyethyl starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hypotension
Measured: Anesthesia begin (0 min) to 120 min after anesthesia
Secondary outcomes (6)
Recurrence of hypotension after ephedrine or phenylephrine
Measured: Anesthesia begin (0 min) to 120 min after anesthesia
Consumption of ephedrine and phenylephrine
Measured: Anesthesia begin (0 min) to 120 min after anesthesia
Duration of hypotension
Measured: Anesthesia begin (0 min) to 120 min after anesthesia
Oxygen saturation during hypotension
Measured: Anesthesia begin (0 min) to 120 min after anesthesia
One-min and 5-min Apgar scores
Measured: The first and fifth minute after cesarean successful delivery
Low umbilical cord pH (artery < 7.20)
Measured: At the time of successful delivery (0 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Nanjing Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013090
- Sponsor's protocol ID
- NMU-200911-MZ020
- Other IDs
- NJFY09331M041
- Acronym
- VOHOCUNA
- Status last verified
- Dec 2009
- First submitted
- 12 Nov 2009
- Last updated
- 23 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Volume-hypotension Association in Elective Cesarean Section Under Neuraxial Anesthesia
- ClinicalTrials.gov ID
- NCT01013090
- Acronym / sponsor ID
- VOHOCUNA / NMU-200911-MZ020
- Conditions
- Cesarean Section
- Keywords
- Epidural anesthesia, Spinal anesthesia, Combined spinal-epidural anesthesia, Fluid therapy, Crystalloid, Colloid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Nov 2009 (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.
Hypotension resulted from neuraxial block is a common problem, of which is a special issue in patients undergoing Cesarean section. A large number of studies and clinical guidelines suggest that fluid loading, pre- or co-anesthesia, is a promising manner in preventing hypotension. However, it is still a controversy because the fact of a relatively increased blood volume in parturients. In addition, although it is effective of fluid management, it's precise relationship between fluid (crystalloid or colloid) volume and the proportion of hypotension in Cesarean patients under neuraxial anesthesia is still unknown. The investigators designed this trial to clarify the accurate relationship between fluid volume in an escalated manner and the occurrence of hypotension analyzed with a non-linear regression, and wanted to present the 50% effective volume (EV50) of fluid including crystalloid and colloid in preventing hypotension in patients undergoing Cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Epidural crystalloid | Active comparator | Drug: Ringer's LactateCrystalloid (Ringer's Lactate) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section |
| Epidural colloid | Active comparator | Drug: Six percent hydroxyethyl starchColloid (6% hydroxyethyl starch) is given pre-, co- and post-epidural anesthesia in patients undergoing Cesarean section |
| Spinal crystalloid | Active comparator | Drug: Ringer's LactateCrystalloid (Ringer's Lactate) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section |
| Spinal colloid | Active comparator | Drug: Six percent hydroxyethyl starchColloid (6% hydroxyethyl starch) is given pre-, co- and post-spinal anesthesia in patients undergoing Cesarean section |
| CSEA crystalloid | Active comparator | Drug: Ringer's LactateCrystalloid (Ringer's Lactate) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section |
| CSEA colloid | Active comparator | Drug: Six percent hydroxyethyl starchColloid (6% hydroxyethyl starch) is given pre-, co- and post-CSEA anesthesia in patients undergoing Cesarean section |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 21-40 yr
- First time of delivery
- ASA status I-II
- No premature
- No genetic and infectious diseases
Key exclusion criteria (10 listed)
- < 21 yr
- > 40 yr
- Subjects with cardiac and pulmonary disorders
- Dislocation of placenta
- Pregnant hypertension
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 |
|---|---|---|
| Ringer's LactateAlso: Lactated Ringer's solutionRinger's Lactate 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks | Drug | CSEA crystalloid, Epidural crystalloid, Spinal crystalloid |
| Six percent hydroxyethyl starchAlso: HES/HAESSix percent hydroxyethyl starch 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 15 ml/kg is given to patients pre-, co- and post-neuraxial blocks | Drug | CSEA colloid, Epidural colloid, Spinal colloid |
Primary outcome
Rate of hypotension
Time frame: Anesthesia begin (0 min) to 120 min after anesthesia
6 secondary outcomes
Recurrence of hypotension after ephedrine or phenylephrine
Time frame: Anesthesia begin (0 min) to 120 min after anesthesia
Consumption of ephedrine and phenylephrine
Time frame: Anesthesia begin (0 min) to 120 min after anesthesia
Duration of hypotension
Time frame: Anesthesia begin (0 min) to 120 min after anesthesia
Oxygen saturation during hypotension
Time frame: Anesthesia begin (0 min) to 120 min after anesthesia
One-min and 5-min Apgar scores
Time frame: The first and fifth minute after cesarean successful delivery
Low umbilical cord pH (artery < 7.20)
Time frame: At the time of successful delivery (0 min)
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 23 Dec 2009.
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's Lactate and Six percent hydroxyethyl starch in people with Cesarean Section, run by Nanjing Medical University at 1 site in China.
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 6 inclusion and 10 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 23 Dec 2009. 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 China. 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?
Rate of hypotension (time frame: Anesthesia begin (0 min) to 120 min after anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2009.