Cesarean SectionFMCS-IINCT00973791
Fluid Management for Cesarean Section II
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
Fluid management plays an essential role in cesarean section. In previous study (NCT00488111) the investigators found that prior-epidural anesthesia fluid management produced a more significant role in stabilizing the blood pressure and better prognosis after cesarean delivery than that of the posterior-anesthesia… 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 1 siteChina
- Study dates
- Oct 2008to May 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
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- Unwilling to cooperation
- Need intraoperative administration of vascular active agents
- With significant delivery side effects
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Fluid Management for Cesarean Section Undergoing Spinal Anesthesia
Fluid management plays an essential role in cesarean section. In previous study (NCT00488111) the investigators found that prior-epidural anesthesia fluid management produced a more significant role in stabilizing the blood pressure and better prognosis after cesarean delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time interval before reaching the best state of anesthesia, so the fluid management also has a relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly except for the epidural anesthesia, whereas spinal anesthesia would produce more significant fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed whether the prior-spinal anesthesia fluid management also produced similar effect on hemodynamic characteristics to the epidural anesthesia.
- Conditions
- Cesarean Section
- Being tested
- Ringer's Lactate, Six percent hydroxyethyl starch
- Keywords
- Spinal anesthesia, Fluid therapy
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 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section
Six percent hydroxyethyl starchDrug
Also called HES/HAES
Hydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Prior crystalloid | Active comparator | Crystalloid (Ringer's Lactate) was given before spinal anesthesia Receives: Drug: Ringer's Lactate |
| Posterior crystalloid | Active comparator | Crystalloid (Ringer's Lactate) was given after spinal anesthesia Receives: Drug: Ringer's Lactate |
| Prior colloid | Active comparator | Colloid (6% hydroxyethyl starch) was given before spinal anesthesia Receives: Drug: Six percent hydroxyethyl starch |
| Posterior colloid | Active comparator | Colloid (6% hydroxyethyl starch) was given after spinal anesthesia 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 (7)
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
Total volume of colloid or crystalloid
Measured: Fifteen minutes before anesthesia to 120 min after anesthesia
One-min and 5-min Apgar scores
Measured: The first and fifth minute after cesarean successful delivery
Oxygen saturation during hypotension
Measured: Anesthesia begin (0 min) to 120 min after anesthesia
Duration of hypotension
Measured: Anesthesia begin (0 min) to 120 min after anesthesia
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 posted9 Sep 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 860 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973791
- Sponsor's protocol ID
- NJMU-08711MZ
- Acronym
- FMCS-II
- Status last verified
- Sep 2009
- First submitted
- 8 Sep 2009
- Last updated
- 9 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Management for Cesarean Section Undergoing Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT00973791
- Acronym / sponsor ID
- FMCS-II / NJMU-08711MZ
- Conditions
- Cesarean Section
- Keywords
- Spinal anesthesia, Fluid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 860 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Maternity and Child Health Care Hospital
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Sep 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.
Fluid management plays an essential role in cesarean section. In previous study (NCT00488111) the investigators found that prior-epidural anesthesia fluid management produced a more significant role in stabilizing the blood pressure and better prognosis after cesarean delivery than that of the posterior-anesthesia ones. Given epidural anesthesia has a time interval before reaching the best state of anesthesia, so the fluid management also has a relatively adequate time to resuscitation. In reality, spinal anesthesia is used popularly except for the epidural anesthesia, whereas spinal anesthesia would produce more significant fluctuation of the hemodynamics compared with the latter. Herein the investigators proposed whether the prior-spinal anesthesia fluid management also produced similar effect on hemodynamic characteristics to the epidural anesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prior crystalloid | Active comparator | Drug: Ringer's LactateCrystalloid (Ringer's Lactate) was given before spinal anesthesia |
| Posterior crystalloid | Active comparator | Drug: Ringer's LactateCrystalloid (Ringer's Lactate) was given after spinal anesthesia |
| Prior colloid | Active comparator | Drug: Six percent hydroxyethyl starchColloid (6% hydroxyethyl starch) was given before spinal anesthesia |
| Posterior colloid | Active comparator | Drug: Six percent hydroxyethyl starchColloid (6% hydroxyethyl starch) was given after spinal anesthesia |
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 (9 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 8 ml/kg was given intravenously before or after spinal anesthesia in cesarean section | Drug | Posterior crystalloid, Prior crystalloid |
| Six percent hydroxyethyl starchAlso: HES/HAESHydroxyethyl starch (6%) was given before or after spinal anesthesia in cesarean section | Drug | Posterior colloid, Prior colloid |
Primary outcome
Rate of hypotension
Time frame: Anesthesia begin (0 min) to 120 min after anesthesia
7 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
Total volume of colloid or crystalloid
Time frame: Fifteen minutes before anesthesia to 120 min after anesthesia
One-min and 5-min Apgar scores
Time frame: The first and fifth minute after cesarean successful delivery
Oxygen saturation during hypotension
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
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 9 Sep 2009.
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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.
XiaoFeng Shen, MD study chair
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 9 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 9 Sep 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 9 Sep 2009.