Number of Previous Cesarean Sections on the Results of Angiogenic Factors.

Cesarean Section Clinical Trial

Official title:

Effect of Number of Previous Cesarean Sections on the Results of Angiogenic Factors. A Descriptive, Prospective Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06166303
• Other study ID #: U1111-1301-2580
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Saint Thomas Hospital, Panama
• Contact: Osvaldo Reyes, MD
• Phone: +507 65655041
• Email: oreyespanama[@]yahoo.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Diagnostic Test:
• sFlt-1/PGIF
Index of sFlt-1/PGIF

Locations

Country	Name	City	State
Panama	Saint Thomas H	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Index sFlt-1/PIGF	Angiogenic factors, normal value.	From the moment of randomization up until delivery. Between 24-48 hours.
Secondary	Progression to preeclampsia	Number of subjects that develop a preeclampsia	Up until discharge. On average, 7 days