Cesarean SectionFMCSNCT00488111
Fluid Management for Cesarean Section
A study testing Ringer's Lactate and 6% Starch in people with Cesarean Section, run by Nanjing Medical University at 1 site in China.
Trial summary
Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar Score of children and related with the stable hemostasis during the whole process of labor. How to keep circulation in a consistent stability is yet to be known. 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 6% Starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteChina
- Study dates
- May 2007to Aug 2008
- 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 9Show fewer
- Unwilling to cooperation
- Need intraoperative administration of vascular active agents
- With significant delivery side effects
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Management With Ringer's and 6% Starch for Cesarean Section After Epidural or Spinal Anesthesia
Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar Score of children and related with the stable hemostasis during the whole process of labor. How to keep circulation in a consistent stability is yet to be known. The investigators hypothesized that different fluids, crystalloids or colloids, can produced varying effects in keeping the physiological environment of labor from significant fluctuating.
- Conditions
- Cesarean Section
- Being tested
- Ringer's Lactate, 6% Starch
- Keywords
- Regional anesthesia, Fluid Therapy, Hemostasis, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's LactateOther
Also called RL
Ringer's Lactate was used 15min before operation
6% StarchOther
Also called ST
6% Starch was used 15min before operation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Participants were treated with normal Ringer's solution 15 min before the operation. Receives: Other: Ringer's Lactate |
| 2 | Active comparator | 6% Starch was used 15min before operation followed epidural anesthesia. Receives: Other: 6% Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of colloid Total volume of crystalloid Total fluid volume
Measured: 6 months
Secondary outcomes (1)
Percentage reduction in hematocrit, Days in hospital
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2008
- Study completionAug 2008
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.
- 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
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488111
- Sponsor's protocol ID
- NMU-2579FW
- Other IDs
- NMCH2007-221
- Acronym
- FMCS
- Status last verified
- Aug 2008
- First submitted
- 18 Jun 2007
- Last updated
- 14 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Management With Ringer's and 6% Starch for Cesarean Section After Epidural or Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT00488111
- Acronym / sponsor ID
- FMCS / NMU-2579FW
- Conditions
- Cesarean Section
- Keywords
- Regional anesthesia, Fluid Therapy, Hemostasis, Surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- May 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 19 Jun 2007 (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.
Cesarean section-associated hypotension is one of the pivotal factors to influence the Apgar Score of children and related with the stable hemostasis during the whole process of labor. How to keep circulation in a consistent stability is yet to be known. The investigators hypothesized that different fluids, crystalloids or colloids, can produced varying effects in keeping the physiological environment of labor from significant fluctuating.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Ringer's LactateParticipants were treated with normal Ringer's solution 15 min before the operation. |
| 2 | Active comparator | Other: 6% Starch6% Starch was used 15min before operation followed epidural 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: RLRinger's Lactate was used 15min before operation | Other | 1 |
| 6% StarchAlso: ST6% Starch was used 15min before operation | Other | 2 |
Primary outcome
Total volume of colloid Total volume of crystalloid Total fluid volume
Time frame: 6 months
1 secondary outcome
Percentage reduction in hematocrit, Days in hospital
Time frame: 6 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 14 Aug 2008.
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Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
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The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
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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 6% 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 14 Aug 2008. 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?
Total volume of colloid Total volume of crystalloid Total fluid volume (time frame: 6 months). 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 14 Aug 2008.