Urgent Caesarian Section Secondary to Cord ProlapseNCT01524107
Complications: Urgent C Section VS Elective C Section
An observational study of Urgent Caesarian Section Secondary to Cord Prolapse, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The medical literature does not provide sufficient information or recommendation regarding specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections for Prolapsed Cord to those who have… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Urgent Caesarian Section Secondary to Cord Prolapse
- How many people
- 240 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2012to Dec 2017
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing Urgent Caesarian Section for Prolapsed Cord and women undergoing Elective Caesarian Section at Hadassah Medical Center-Har HaTzofim.
Who may be able to join
- women undergoing urgent Caesarian Section for Prolapsed Cord.
- women undergoing Elective Caesarian Section.
Who cannot join
- preterm birth
- multiple gestation
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Comparison of Maternal and Fetal Complications After Urgent Caesarian Section for Prolapsed Cord Versus Elective Caesarian Section.
The medical literature does not provide sufficient information or recommendation regarding specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order to develop a standard treatment protocol. The Medical Record review will include many parameters including complications, type of antibiotic usage etc.
- Keywords
- Prophylaxis Antibiotics, Maternal Complications, Neonatal Complications, Cord Prolapse, Elective Caesarian Section, Maternal Morbidity, Neonatal Morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urgent Caesarian Section | Not described | |
| Elective Caesarian Section | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urgent Caesarian Section Secondary to Cord ProlapseStudies 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Drorith Hochner-Celnikier, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524107
- Sponsor's protocol ID
- CSURGENT-ELECT-HMO-CTIL
- Status last verified
- Dec 2016
- First submitted
- 30 Jan 2012
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal and Fetal Complications After Urgent Caesarian Section for Prolapsed Cord Versus Elective Caesarian Section.
- ClinicalTrials.gov ID
- NCT01524107
- Acronym / sponsor ID
- CSURGENT-ELECT-HMO-CTIL
- Keywords
- Prophylaxis Antibiotics, Maternal Complications, Neonatal Complications, Cord Prolapse, Elective Caesarian Section, Maternal Morbidity, Neonatal Morbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2017 (estimated)
- First posted
- 1 Feb 2012 (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.
The medical literature does not provide sufficient information or recommendation regarding specific antibiotic coverage for urgent Caesarian sections. The goal of this study is to compare maternal and neonatal morbidity of women who have undergone urgent Caesarian Sections for Prolapsed Cord to those who have undergone Elective Caesarian Sections in order to develop a standard treatment protocol. The Medical Record review will include many parameters including complications, type of antibiotic usage etc.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urgent Caesarian Section | – | – |
| Elective Caesarian Section | – | – |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing Urgent Caesarian Section for Prolapsed Cord and women undergoing Elective Caesarian Section at Hadassah Medical Center-Har HaTzofim.
Key inclusion criteria (2 listed)
- women undergoing urgent Caesarian Section for Prolapsed Cord.
- women undergoing Elective Caesarian Section.
Key exclusion criteria (2 listed)
- preterm birth
- multiple gestation
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
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.
Drorith Hochner-Celnikier, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urgent Caesarian Section Secondary to Cord Prolapse, run by Hadassah Medical Organization at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Dec 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Drorith Hochner-Celnikier, MD (00 972 2 5844400, hochner@hadassah.org.il), or a site near the patient. 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 20 Dec 2016.