Pregnant WomenNCT03538106
Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
An observational study of Pregnant Women and Diabetes Type 1, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this study was to identify risk factor of cesarean in this population. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women, Diabetes Type 1, Cesrean Delivery
- How many people
- 153 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to Oct 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All pregnant women with diabetes type 1
Who may be able to join
- Pregnant women with diabetes type 1
- Pregnancy initiated between 2009 and 2015
- Pregnancy followed up in the universitary hospital center of Montpellier
Who cannot join
- Women who deliver in an other center
- women with intraperitoneal injections of insulin
- twin gestation
- termination of pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this study was to identify risk factor of cesarean in this population.
Methods: This study is an observational, retrospective and single-center study from the hospital of Montpellier. All the pregnancies, planned or not, with subcutaneous insulin infusion or multiple daily injections of insulin, in patients with diabetes type 1 between 2009 and 2015, after 24 weeks of gestation were included. All the data were retrospectively collected by the principal investigator with computer and paper files.
- Conditions
- Pregnant Women, Diabetes Type 1, Cesrean Delivery
- Keywords
- Cesrean delivery, Risks factors, Diabetes Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors associated with a cesarean delivery in patients with diabetes type 1
he statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.
Measured: 6 years
Secondary outcomes (2)
Risk factors associated with a planned cesarean delivery in patients with diabetes type 1
the statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.
Measured: 6 years
Risk factors associated with an emergency cesarean delivery in patients with diabetes type 1
the statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study startNov 2016
- Primary completionDec 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538106
- Sponsor's protocol ID
- RECHMPL17_0332
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 25 May 2018
- 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 25 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03538106
- Acronym / sponsor ID
- RECHMPL17_0332
- Conditions
- Pregnant Women, Diabetes Type 1, Cesrean Delivery
- Keywords
- Cesrean delivery, Risks factors, Diabetes Type 1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 25 May 2018 (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.
Introduction : Cesarean rate varies from 45% to 73% in the literature in patient with diabetes type 1. Having a prior C-section is the most important risk factor. The aim of this study was to identify risk factor of cesarean in this population.
Methods: This study is an observational, retrospective and single-center study from the hospital of Montpellier. All the pregnancies, planned or not, with subcutaneous insulin infusion or multiple daily injections of insulin, in patients with diabetes type 1 between 2009 and 2015, after 24 weeks of gestation were included. All the data were retrospectively collected by the principal investigator with computer and paper files.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All pregnant women with diabetes type 1
Key inclusion criteria (3 listed)
- Pregnant women with diabetes type 1
- Pregnancy initiated between 2009 and 2015
- Pregnancy followed up in the universitary hospital center of Montpellier
Key exclusion criteria (4 listed)
- Women who deliver in an other center
- women with intraperitoneal injections of insulin
- twin gestation
- termination of pregnancy
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
Risk factors associated with a cesarean delivery in patients with diabetes type 1
Time frame: 6 years
he statistical analysis was made with multiple logistic regression using SAS V9.1 and R V3.1.1 programs.
2 secondary outcomes
Risk factors associated with a planned cesarean delivery in patients with diabetes type 1
Time frame: 6 years
Risk factors associated with an emergency cesarean delivery in patients with diabetes type 1
Time frame: 6 years
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 25 May 2018.
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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 Pregnant Women and Diabetes Type 1, run by University Hospital, Montpellier 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 3 inclusion and 4 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 25 May 2018. 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?
Risk factors associated with a cesarean delivery in patients with diabetes type 1 (time frame: 6 years). 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 25 May 2018.