Cesarean SectionNCT06166303
Number of Previous Cesarean Sections on the Results of Angiogenic Factors.
An observational study of Cesarean Section, run by Saint Thomas Hospital, Panama at 1 site in Panama.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- sFlt-1/PGIF
- How many people
- 540 participants
- Where
- 1 sitePanama
- Study dates
- 1 Oct 2025to 30 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant woman with a previous cesarean section
Who may be able to join
- 36 weeks of gestation or more
- Singleton pregnancy
- Previous cesarean section (case)
Who cannot join
- Vasculitis
- Twin pregnancy
- Chronic endometritis
- Smoking
- Lupus
- Renal failure
- Liver disease
- Thrombocytopenia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Cesarean Section
- Being tested
- sFlt-1/PGIF
- Keywords
- Cesarean section, Angiogenic factors, Preeclampsia
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sFlt-1/PGIFDiagnostic test
Index of sFlt-1/PGIF
| Study group | Role | What they receive |
|---|---|---|
| Previous Cesarean Section | Subjects with one or more previous cesarean sections Receives: Diagnostic Test: sFlt-1/PGIF | |
| No Cesarean | Subjects scheduled for an elective or urgent cesarean, but no history of previous cesarean section Receives: Diagnostic Test: sFlt-1/PGIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index sFlt-1/PIGF
Angiogenic factors, normal value.
Measured: From the moment of randomization up until delivery. Between 24-48 hours.
Secondary outcomes (1)
Progression to preeclampsia
Number of subjects that develop a preeclampsia
Measured: Up until discharge. On average, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Prospective
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, Principal investigator, Hospital Santo Tomás
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166303
- Sponsor's protocol ID
- U1111-1301-2580
- Status last verified
- Aug 2025
- First submitted
- 4 Dec 2023
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Number of Previous Cesarean Sections on the Results of Angiogenic Factors. A Descriptive, Prospective Study.
- ClinicalTrials.gov ID
- NCT06166303
- Acronym / sponsor ID
- U1111-1301-2580
- Conditions
- Cesarean Section
- Keywords
- Cesarean section, Angiogenic factors, Preeclampsia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 12 Dec 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previous Cesarean Section | – | Diagnostic Test: sFlt-1/PGIFSubjects with one or more previous cesarean sections |
| No Cesarean | – | Diagnostic Test: sFlt-1/PGIFSubjects scheduled for an elective or urgent cesarean, but no history of previous cesarean section |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant woman with a previous cesarean section
Key inclusion criteria (3 listed)
- 36 weeks of gestation or more
- Singleton pregnancy
- Previous cesarean section (case)
Key exclusion criteria (8 listed)
- Vasculitis
- Twin pregnancy
- Chronic endometritis
- Smoking
- Lupus
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 |
|---|---|---|
| sFlt-1/PGIFIndex of sFlt-1/PGIF | Diagnostic test | No Cesarean, Previous Cesarean Section |
Primary outcome
Index sFlt-1/PIGF
Time frame: From the moment of randomization up until delivery. Between 24-48 hours.
Angiogenic factors, normal value.
1 secondary outcome
Progression to preeclampsia
Time frame: Up until discharge. On average, 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Osvaldo Reyes principal investigator
Hospital Santo Tomás
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 Cesarean Section, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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 8 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: opening soon, as of the sponsor's last update on 26 Aug 2025. 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 Panama. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osvaldo Reyes, MD (+507 65655041, oreyespanama@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Index sFlt-1/PIGF (time frame: From the moment of randomization up until delivery. Between 24-48 hours.). 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 26 Aug 2025.