Establishment of a Perinatal Database and a Bank of Biological Materials

Pregnancy Clinical Trial

Official title:

Establishment of a Clinical Perinatal Database and Bank of Biological Materials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00339235
• Other study ID #: 999998001
• Secondary ID: OH98-CH-N001
• Status: Completed
• Start date: January 6, 1998
• Est. completion date: November 22, 2016

Study information

• Verified date: February 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this project is to establish a clinical database and a bank of biological materials which will be used to improve the pathophysiologic understanding of the mechanisms underlying various pregnancy diseases. The US-Mexico Reproductive Health Research Development Workshop, sponsored by the NIH, recommended that the setting up of "tissue, blood, and placental banks from human and relevant animal models should be developed to aid in understanding how prenatal conditions relate to pathological consequences in adult life".

A large observational study in the United States of America, the National Collaborative Perinatal Project (NCPP), was conducted over 30 years ago (1959-1966) and has yielded a large amount of useful information. However standards of obstetrical and neonatal care have changed significantly over the last 30 years. Thus the setting up of a contemporary clinical perinatal database and bank of biological materials is required. In order to obtain sufficient data for statistical analysis a large sample size is necessary.

We propose to carry out this project at Sotero del Rio Hospital, Santiago Chile as this hospital has a delivery rate of approximately 14,000 women per year. Previous research collaborative efforts between the Sotero del Rio Hospital and the PRB have been carried out in compliance with NIH research regulations. Sotero del Rio Hospital has had previous successful negotiations of Single Project Assurances (SPA) with the NIH.

Information will be collected from clinical history taking, physical examination, sonographic examination and standard laboratory procedures. The bank of biological fluids and tissues will include maternal blood, umbilical cord plasma, amniotic fluid, maternal urine and placental tissue. No procedures will be carried out on patients that are not part of standard of care at Sotero del Rio Hospital.

Description:

The aim of this project is to establish a clinical database and a bank of biological materials which will be used to improve the pathophysiologic understanding of the mechanisms underlying various pregnancy diseases. The US-Mexico Reproductive Health Research Development Workshop, sponsored by the NIH, recommended that the setting up of "tissue, blood, and placental banks from human and relevant animal models should be developed to aid in understanding how prenatal conditions relate to pathological consequences in adult life".

A large observational study in the United States of America, the National Collaborative Perinatal Project (NCPP), was conducted over 30 years ago (1959-1966) and has yielded a large amount of useful information. However standards of obstetrical and neonatal care have changed significantly over the last 30 years. Thus the setting up of a contemporary clinical perinatal database and bank of biological materials is required. In order to obtain sufficient data for statistical analysis a large sample size is necessary.

We propose to carry out this project at Sotero del Rio Hospital, Santiago Chile as this hospital has a delivery rate of approximately 14,000 women per year. Previous research collaborative efforts between the Sotero del Rio Hospital and the PRB have been carried out in compliance with NIH research regulations. Sotero del Rio Hospital has had previous successful negotiations of Single Project Assurances (SPA) with the NIH.

Information will be collected from clinical history taking, physical examination, sonographic examination and standard laboratory procedures. The bank of biological fluids and tissues will include maternal blood, umbilical cord plasma, amniotic fluid, maternal urine and placental tissue. No procedures will be carried out on patients that are not part of standard of care at Sotero del Rio Hospital.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30570
• Est. completion date: November 22, 2016
• Est. primary completion date: November 22, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• ELIGIBILITY CRITERIA:

Women who receive care at participating units will be eligible for participation in this study.

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Pregnancy
• Premature Birth
• Preterm Birth
• Preterm Labor

Locations

Country	Name	City	State
United States	Hutzel Women's Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Branch DW, Andres R, Digre KB, Rote NS, Scott JR. The association of antiphospholipid antibodies with severe preeclampsia. Obstet Gynecol. 1989 Apr;73(4):541-5. — View Citation

Pollack RN, Divon MY. Intrauterine growth retardation: definition, classification, and etiology. Clin Obstet Gynecol. 1992 Mar;35(1):99-107. doi: 10.1097/00003081-199203000-00015. No abstract available. — View Citation

Wilkins-Haug L, Roberts DJ, Morton CC. Confined placental mosaicism and intrauterine growth retardation: a case-control analysis of placentas at delivery. Am J Obstet Gynecol. 1995 Jan;172(1 Pt 1):44-50. doi: 10.1016/0002-9378(95)90082-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1.Maternal mortality 2.Route of delivery 3.Infection related complications 4.Bleeding, blood loss and transfusion requirements 5.Hypertensive disorders 6.Venous and arterial thrombotic events 7. Any other complications of pregnancy, labor or del...	Data and specimen analysis is ongoing	Ongoing
Secondary	Birthweight; Perinatal mortality; Congenital anomalies; Intrauterine growth retardation; Respiratory distress syndrome; Chronic pulmonary disease; Intraventricular hemorrhage;Necrotizing enterocolitis; Retinopathy of prematurity	Birthweight; Perinatal mortality; Congenital anomalies; Intrauterine growth retardation; Respiratory distress syndrome; Chronic pulmonary disease; Intraventricular hemorrhage;Necrotizing enterocolitis; Retinopathy of prematurity	Ongoing