- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06166303
Number of Previous Cesarean Sections on the Results of Angiogenic Factors.
Effect of Number of Previous Cesarean Sections on the Results of Angiogenic Factors. A Descriptive, Prospective Study.
Hypertensive disorders of pregnancy (HPT) are an important cause of maternal-feto-neonatal morbidity and mortality, being one of the three leading causes of maternal death in our country and in developing countries. The only cure for THE is termination of pregnancy, which ends up being a decision in which gestational age and maternal risks must be balanced. Angiogenic factors have come to occupy an indispensable place in the arsenal of tools that can be used to separate the patient with a high likelihood of complications from those in whom prolongation of pregnancy could represent an important neonatal benefit.
Although the usefulness of angiogenic factors in these scenarios is known, little is known about the effects that other conditions might have on their serum levels, mainly those that have an effect on trophoblastic invasion, the process that initiates implantation of the pregnancy in the endometrium. The purpose of the present study is to assess the effect that a history of uterine surgery, such as caesarean section, might have on angiogenic factor scores in subjects with no history of a hypertensive disorder of pregnancy.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Osvaldo Reyes, MD
- Phone Number: +507 65655041
- Email: oreyespanama@yahoo.es
Study Locations
-
-
Provincia de Panamá
-
Panama City, Provincia de Panamá, Panama
- Saint Thomas H
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 36 weeks of gestation or more
- Singleton pregnancy
- Previous cesarean section (case)
Exclusion Criteria:
- Vasculitis
- Twin pregnancy
- Chronic endometritis
- Smoking
- Lupus
- Renal failure
- Liver disease
- Thrombocytopenia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Previous Cesarean Section
Subjects with one or more previous cesarean sections
|
Index of sFlt-1/PGIF
|
|
No Cesarean
Subjects scheduled for an elective or urgent cesarean, but no history of previous cesarean section
|
Index of sFlt-1/PGIF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Index sFlt-1/PIGF
Time Frame: From the moment of randomization up until delivery. Between 24-48 hours.
|
Angiogenic factors, normal value.
|
From the moment of randomization up until delivery. Between 24-48 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression to preeclampsia
Time Frame: Up until discharge. On average, 7 days
|
Number of subjects that develop a preeclampsia
|
Up until discharge. On average, 7 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Osvaldo Reyes, Hospital Santo Tomas
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1301-2580
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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