Elective Cesarean SectionNCT00330512
Maternal Hypotension During Cesarean Section and Short Term Neonatal Outcome.
An observational study of Elective Cesarean Section and Maternal Hypotention, run by Sheba Medical Center.
Trial summary
About 20-25% of deliveries are by cesarean section. Most are elective with use of regional anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It have the risk of reduction of blood flow to the placenta and the fetus. Read more about this study
- Who is it for?
- Ages 1 to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Elective Cesarean Section, Maternal Hypotention
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Jul 2007
- Phase
- Observational
- 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 1 to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Study population: primary care clinic
Who may be able to join
- fullterm infants, born by elective cesarean section using regional anasthesia.
Who cannot join
- preterms, urgent CS, CS using general anasthesia, Multiple pregnancy, Congenital malformations.
About this study
Official title: Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome.
About 20-25% of deliveries are by cesarean section. Most are elective with use of regional anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It have the risk of reduction of blood flow to the placenta and the fetus.
No studies had followed the newborns their first days of live,of mothers who developed hypotension in durins CS.
Read the detailed description
A reterospective study of all full term babies, born in elective cesarean section with use of regional anesthesia. Two groups will be define rgarding maternal hypotention following regional anesthesia - maternal hypotention (study group) or normal maternal BP. The definition of Maternal hypotension: decrease in 10% or more in mean BP in compared to first BP taken at admition.
Data will colect from mothers and neonates records as well as operation data. Maternal data: gravida, parity, diseases, medications, demographics, and all data regarding the operation (blood pressures, Heart rates, saturation, treatment given etc.).
Infant data: gestational age, birth weight, sex, Apgar, cord pH, clinical manifestations, medications, time of hospitalization.
- Conditions
- Elective Cesarean Section, Maternal Hypotention
- Keywords
- regional anestesia, cesarean section, hypotention, newborn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Ayala Maayan, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330512
- Sponsor's protocol ID
- SHEBA-06-4117-AM-CTIL
- Status last verified
- Jun 2009
- First submitted
- 25 May 2006
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Hypotension During Elective Cesarean Section and Short Term Neonatal Outcome.
- ClinicalTrials.gov ID
- NCT00330512
- Acronym / sponsor ID
- SHEBA-06-4117-AM-CTIL
- Conditions
- Elective Cesarean Section, Maternal Hypotention
- Keywords
- regional anestesia, cesarean section, hypotention, newborn
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 26 May 2006 (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.
About 20-25% of deliveries are by cesarean section. Most are elective with use of regional anesthesia (spinal/epidural). Drop of blood pressure after regional anesthesia is common. It have the risk of reduction of blood flow to the placenta and the fetus.
No studies had followed the newborns their first days of live,of mothers who developed hypotension in durins CS.
Detailed description
A reterospective study of all full term babies, born in elective cesarean section with use of regional anesthesia. Two groups will be define rgarding maternal hypotention following regional anesthesia - maternal hypotention (study group) or normal maternal BP. The definition of Maternal hypotension: decrease in 10% or more in mean BP in compared to first BP taken at admition.
Data will colect from mothers and neonates records as well as operation data. Maternal data: gravida, parity, diseases, medications, demographics, and all data regarding the operation (blood pressures, Heart rates, saturation, treatment given etc.).
Infant data: gestational age, birth weight, sex, Apgar, cord pH, clinical manifestations, medications, time of hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- primary care clinic
Key inclusion criteria (1 listed)
- fullterm infants, born by elective cesarean section using regional anasthesia.
Key exclusion criteria (1 listed)
- preterms, urgent CS, CS using general anasthesia, Multiple pregnancy, Congenital malformations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
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Maternal and Fetal Outcomes in Elective vs Emergency Cesarean Section
Maternal and Fetal Outcomes in Elective vs Emergency Cesarean Section
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Gastric Ultrasound, Elective Cesarean Section
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.
Ayala Maayan, MD principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Cesarean Section and Maternal Hypotention, run by Sheba Medical Center.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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.
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 30 Jun 2009; AzTrials last refreshed its copy on 6 Nov 2026.