Placental Growth and Adverse Pregnancy Outcomes

Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01669525

Enrollment

1043

Registered

2012-08-21

Start date

2009-11-30

Completion date

2016-06-30

Last updated

2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension Induced by Pregnancy, IUGR, Pre-Eclampsia

Brief summary

The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.

Detailed description

The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed for measurement of placental volumes during pregnancy. It may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. Furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. The investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* All singleton gestations presenting for Sequential Screen testing at HUP * patients competent to provide verbal informed consent

Exclusion criteria

* Multiple gestations * patients not competent to provide informed consent * patients found to be too late for the Sequential Screen * pregnancy losses 20 weeks gestation * major fetal anomalies * patient delivering outside of the UPHS

Design outcomes

Primary

Measure	Time frame	Description
Small for gestational birth weight (SGA-dichotomous)	from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)	Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.

Secondary

Measure	Time frame	Description
Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.	post partum	Information about pregnancy outcomes will be retrieved from the maternal and neonatal medical record post partum.

Countries

United States

Outcome results