SurgeryNCT05759507
Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy
An observational study of Surgery and Pregnancy Complications, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
About 2% of pregnant women are going through from surgery during pregnancy. These are mainly represented by emergencies like abdominal conditions such as appendicitis. Pregnancy raises the issue of possible diagnostic confusion associated with operational difficulties related to a gravid uterus, i.e. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Surgery, Pregnancy Complications, Pregnancy Related
- What is being tested?
- abdominal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Dec 2021
- How long will I take part?
- 7 Years
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women going through pregnancy with no limitation of age
Who may be able to join
- Women going through pregnancy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site
Maternite Regionale et Universitaire de Nancy
Nancy, Meurthe-et-moselle, 54000
About this study
Official title: Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy :a Retrospective Study Between 2014 and 2021
About 2% of pregnant women are going through from surgery during pregnancy. These are mainly represented by emergencies like abdominal conditions such as appendicitis.
Pregnancy raises the issue of possible diagnostic confusion associated with operational difficulties related to a gravid uterus, i.e. increased in volume, and possible induced obstetric complications like premature delivery or miscarriage. late.
The management of these patients is therefore complex and the literature is poor on the subject.
Read the detailed description
In the CHRU of Nancy because of the lack of guidelines, there is no guidelines on the management around urgent surgery during pregnancy.
The aim is to describe how patients on the 7 last years where taking care of and to examine if there where mistakes and delay due to pregnancy.'
The aim is also to describe the consequences of the surgery and analyse the end of the pregancy
- Conditions
- Surgery, Pregnancy Complications, Pregnancy Related
- Being tested
- abdominal surgery
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| patients | Women undergo pregnancy from 5 SA to 41 SA with no limitation of age Receives: Procedure: abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with no mistakes from the diagnosis to the surgery.
days of delay in the diagnosis ? error ? Diagnostic of certitude is established during surgery
Measured: 1 year
Secondary outcomes (1)
Impact on pregnancy
The impact on pregnancy is defined as the issues after surgery such as miscarries, premature labor, neonatal asphyxie etc..
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study startJan 2014
- Primary completionJan 2014
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Other
- Enrolment
- 75 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TOURNIER Mathilde, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759507
- Sponsor's protocol ID
- 6030/2107
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Practices at the University Hospital of Nancy in the Context of Surgery During Pregnancy :a Retrospective Study Between 2014 and 2021
- ClinicalTrials.gov ID
- NCT05759507
- Acronym / sponsor ID
- 6030/2107
- Conditions
- Surgery, Pregnancy Complications, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 8 Mar 2023 (actual)
- 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 2% of pregnant women are going through from surgery during pregnancy. These are mainly represented by emergencies like abdominal conditions such as appendicitis.
Pregnancy raises the issue of possible diagnostic confusion associated with operational difficulties related to a gravid uterus, i.e. increased in volume, and possible induced obstetric complications like premature delivery or miscarriage. late.
The management of these patients is therefore complex and the literature is poor on the subject.
Detailed description
In the CHRU of Nancy because of the lack of guidelines, there is no guidelines on the management around urgent surgery during pregnancy.
The aim is to describe how patients on the 7 last years where taking care of and to examine if there where mistakes and delay due to pregnancy.'
The aim is also to describe the consequences of the surgery and analyse the end of the pregancy
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Procedure: abdominal surgeryWomen undergo pregnancy from 5 SA to 41 SA with no limitation of age |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women going through pregnancy with no limitation of age
Key inclusion criteria (1 listed)
- Women going through pregnancy
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| abdominal surgery | Procedure or surgery | patients |
Primary outcome
Number of patients with no mistakes from the diagnosis to the surgery.
Time frame: 1 year
days of delay in the diagnosis ? error ? Diagnostic of certitude is established during surgery
1 secondary outcome
Impact on pregnancy
Time frame: 1 year
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 8 Mar 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery and Pregnancy Complications, run by Central Hospital, Nancy, France at 1 site in France.
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: finished, as of the sponsor's last update on 8 Mar 2023. 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 France. 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?
Number of patients with no mistakes from the diagnosis to the surgery. (time frame: 1 year). 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 8 Mar 2023.