Women Who Had at Lease One Cesarean Section in the PastNCT02641574
Relation Between Complication in Repeated Cesarean Sections, Newborn Outcome and Surgical Characteristics and Maternal Information
An observational study of Women Who Had at Lease One Cesarean Section in the Past, run by Rambam Health Care Campus.
Trial summary
To examine the relation between complication in Repeated Cesarean Sections and Newborn Outcome compared to number of repeated cesarean section and reasonf or surgery and personal medical information to the mother Read more about this study
- Who is it for?
- Ages 17 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Who Had at Lease One Cesarean Section in the Past
- What is being tested?
- compare complication
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Nov 2015
- 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 17 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: All women who underwent a cesarean section at Rambam Medical Center who had at least one cesarean section in the past
Who may be able to join
- women who had at least one cesarean section -
Who cannot join
- women that this was their first cesarean section
- -
About this study
Official title: Relation Between Complication in Repeated Cesarean Sections Compared With Newborn Outcome,Surgical Characteristics and Maternal Information
To examine the relation between complication in Repeated Cesarean Sections and Newborn Outcome compared to number of repeated cesarean section and reasonf or surgery and personal medical information to the mother
- Being tested
- compare complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compare complicationOther
| Study group | Role | What they receive |
|---|---|---|
| previous 1 | women who have had in their past one cesarean section Receives: Other: compare complication | |
| previous 2 | women who have had in their past 2 cesarean sections Receives: Other: compare complication | |
| previous 3 | women who have had in their past 3 cesarean sections Receives: Other: compare complication | |
| previous 4 | women who have had in their past 4 cesarean sections Receives: Other: compare complication |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical complication compared to number of repeated cesarean sections
Measured: during the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startJan 2009
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women Who Had at Lease One Cesarean Section in the PastStudies 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yechiel Burke MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641574
- Sponsor's protocol ID
- 102892
- Status last verified
- Dec 2015
- First submitted
- 23 Dec 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Complication in Repeated Cesarean Sections Compared With Newborn Outcome,Surgical Characteristics and Maternal Information
- ClinicalTrials.gov ID
- NCT02641574
- Acronym / sponsor ID
- 102892
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2015 (actual)
- First posted
- 29 Dec 2015 (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.
To examine the relation between complication in Repeated Cesarean Sections and Newborn Outcome compared to number of repeated cesarean section and reasonf or surgery and personal medical information to the mother
Study design
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| previous 1 | – | Other: compare complicationwomen who have had in their past one cesarean section |
| previous 2 | – | Other: compare complicationwomen who have had in their past 2 cesarean sections |
| previous 3 | – | Other: compare complicationwomen who have had in their past 3 cesarean sections |
| previous 4 | – | Other: compare complicationwomen who have had in their past 4 cesarean sections |
Who may qualify
- Ages
- 17 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All women who underwent a cesarean section at Rambam Medical Center who had at least one cesarean section in the past
Key inclusion criteria (1 listed)
- women who had at least one cesarean section -
Key exclusion criteria (2 listed)
- women that this was their first cesarean section
- -
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 |
|---|---|---|
| compare complication | Other | previous 1, previous 2, previous 3, previous 4 |
Primary outcome
surgical complication compared to number of repeated cesarean sections
Time frame: during the surgery
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 29 Dec 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Women Who Had at Lease One Cesarean Section in the Past, run by Rambam Health Care Campus.
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 2 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 29 Dec 2015. 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 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?
surgical complication compared to number of repeated cesarean sections (time frame: during the surgery). 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 29 Dec 2015.