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

Not yet recruiting

• Conditions: Cesarean Section
• Interventions: Diagnostic Test: sFlt-1/PGIF

• Registration Number: NCT06166303
• Lead Sponsor: Saint Thomas Hospital, Panama

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Study Start: 2024-06-01
• Primary Completion: 2024-09-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 540

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Cesarean	sFlt-1/PGIF	Subjects scheduled for an elective or urgent cesarean, but no history of previous cesarean section
Previous Cesarean Section	sFlt-1/PGIF	Subjects with one or more previous cesarean sections

Primary Outcome Measures

Name	Time	Method
Index sFlt-1/PIGF	From the moment of randomization up until delivery. Between 24-48 hours.	Angiogenic factors, normal value.

Secondary Outcome Measures

Name	Time	Method
Progression to preeclampsia	Up until discharge. On average, 7 days	Number of subjects that develop a preeclampsia

Trial Locations

Locations (1)

Saint Thomas H; 🇵🇦 Panama, Panama