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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06166303
Other study ID # U1111-1301-2580
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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