Cesarean SectionPAFUMINNCT00987701
Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors
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
Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. 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
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to May 2011
- 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
- Unwilling to cooperation
- 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: Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors
Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. In addition, neuraxial anesthesia including epidural, spinal and combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery, and these anesthesia techniques will undoubtedly evoke hypotension and corresponding hemodynamic alteration, of which would result in decreasing in umbilical placental insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants. Fluid management, such as crystalloid and colloid, is the common ones given before or / and after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior scorings, and could produce positive effect on later intelligence development. Herein the investigators hypothesized that effective perineuraxial anesthesia fluid management during cesarean section would prevent the occurrence of hypotension and improve infant's neurobehavior scorings.
- Conditions
- Cesarean Section
- Being tested
- Ringer's Lactate, Six percent hydroxyethyl starch
- Keywords
- Neurobehavior, Development, Fluid management, Neuraxial anesthesia
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 epidural, spinal or CSEA in cesarean section
Six percent hydroxyethyl starchDrug
Also called HES/HAES
Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid resuscitation | Active comparator | Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia Receives: Drug: Ringer's Lactate |
| Colloid resuscitation | Active comparator | Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia Receives: Drug: Six percent hydroxyethyl starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Measured: Immediate after birth (0 min)
Secondary outcomes (11)
Apgar scoring
Measured: One min and 5min after birth.
Umbilical-cord gases analysis
Measured: At the time baby was born (0min)
Neonatal sepsis evaluation
Measured: One hour after the baby was born
Neonatal antibiotic treatment
Measured: One hour after the baby was born
Incidence of maternal side effects
Measured: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Measured: 30min after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Measured: 1h after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Measured: 8h after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Measured: 1d after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Measured: 1wk after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Measured: 1month after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2011
- Study completionMay 2011
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987701
- Sponsor's protocol ID
- NJMU-0932MZ
- Other IDs
- NMUK2190
- Acronym
- PAFUMIN
- Status last verified
- Jul 2011
- First submitted
- 30 Sep 2009
- Last updated
- 27 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors
- ClinicalTrials.gov ID
- NCT00987701
- Acronym / sponsor ID
- PAFUMIN / NJMU-0932MZ
- Conditions
- Cesarean Section
- Keywords
- Neurobehavior, Development, Fluid management, Neuraxial anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 1 Oct 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.
Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. In addition, neuraxial anesthesia including epidural, spinal and combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery, and these anesthesia techniques will undoubtedly evoke hypotension and corresponding hemodynamic alteration, of which would result in decreasing in umbilical placental insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants. Fluid management, such as crystalloid and colloid, is the common ones given before or / and after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior scorings, and could produce positive effect on later intelligence development. Herein the investigators hypothesized that effective perineuraxial anesthesia fluid management during cesarean section would prevent the occurrence of hypotension and improve infant's neurobehavior scorings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloid resuscitation | Active comparator | Drug: Ringer's LactateCrystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia |
| Colloid resuscitation | Active comparator | Drug: Six percent hydroxyethyl starchColloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial 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 (8 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 epidural, spinal or CSEA in cesarean section | Drug | Crystalloid resuscitation |
| Six percent hydroxyethyl starchAlso: HES/HAESHydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section | Drug | Colloid resuscitation |
Primary outcome
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time frame: Immediate after birth (0 min)
11 secondary outcomes
Apgar scoring
Time frame: One min and 5min after birth.
Umbilical-cord gases analysis
Time frame: At the time baby was born (0min)
Neonatal sepsis evaluation
Time frame: One hour after the baby was born
Neonatal antibiotic treatment
Time frame: One hour after the baby was born
Incidence of maternal side effects
Time frame: Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time frame: 30min after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time frame: 1h after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time frame: 8h after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time frame: 1d after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time frame: 1wk after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)
Time frame: 1month after birth
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 27 Jul 2011.
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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 8 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 27 Jul 2011. 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?
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB) (time frame: Immediate after birth (0 min)). 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 27 Jul 2011.