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

NCT06166303 | Not Yet Recruiting

• 1 other identifier: U1111-1301-2580
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Keywords

Cesarean section; Angiogenic factors; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• Index sFlt-1/PIGF

  Angiogenic factors, normal value.

  From the moment of randomization up until delivery. Between 24-48 hours.

Secondary Outcomes (1)

• Progression to preeclampsia

  Up until discharge. On average, 7 days

Study Arms (2)

Previous Cesarean Section

Subjects with one or more previous cesarean sections

Diagnostic Test: sFlt-1/PGIF

No Cesarean

Subjects scheduled for an elective or urgent cesarean, but no history of previous cesarean section

Diagnostic Test: sFlt-1/PGIF

Interventions

sFlt-1/PGIF DIAGNOSTIC_TEST

Index of sFlt-1/PGIF

No Cesarean; Previous Cesarean Section

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pregnant woman with a previous cesarean section

You may qualify if:

• weeks of gestation or more
• Singleton pregnancy
• Previous cesarean section (case)

You may not qualify if:

• Vasculitis
• Twin pregnancy
• Chronic endometritis
• Smoking
• Lupus
• Renal failure
• Liver disease
• Thrombocytopenia

Sponsors & Collaborators

• Saint Thomas Hospital, Panama: lead

Study Sites (1)

Saint Thomas H

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Osvaldo Reyes

  Hospital Santo Tomás

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Osvaldo Reyes, MD

CONTACT

+507 65655041; oreyespanama@yahoo.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the research deparment

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: October 1, 2025
• Primary Completion: January 30, 2026
• Study Completion: March 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)