Transplacental Gradients and Transport in Intrauterine Growth Restricted (IUGR) Pregnancies Compared to Normal Pregnancies.

NCT02397291 | Terminated Results

• 1 other identifier: 01-517
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the transplacental gradients for 6 polyols and mannose are altered in intrauterine growth restricted (IUGR) pregnancies compared to normal pregnancies and b) to determine the relative contributions of transplacental transport vs production by the conceptus of both inositol (the major polyol) and mannose in IUGR and normal pregnancies using stable isotopic methodology.

Conditions

IUGR; Pregnancy

Keywords

Pregnancy; IUGR

Outcome Measures

Primary Outcomes (4)

• Maternal Enrichment of Mannose

  The infusion of D-\[U-13C\]mannose and \[U-13C\]myoinositol into the maternal circulation is used to establish the degree of transplacental flux of these 2 carbohydrates and to determine if there is evidence of fetal and/or placental production of either of these substrates.

  Measured at time of cesarean delivery

• Fetal Enrichment of Mannose

  The infusion of D-\[U-13C\]mannose and \[U-13C\]myoinositol into the maternal circulation is used to establish the degree of transplacental flux of these 2 carbohydrates and to determine if there is evidence of fetal and/or placental production of either of these substrates.

  Measured at time of cesarean delivery

• Maternal Enrichment of Myoinositol

  The infusion of D-\[U-13C\]mannose and \[U-13C\]myoinositol into the maternal circulation is used to establish the degree of transplacental flux of these 2 carbohydrates and to determine if there is evidence of fetal and/or placental production of either of these substrates.

  Measured at time of cesarean delivery

• Fetal Enrichment of Myoinositol

  The infusion of D-\[U-13C\]mannose and \[U-13C\]myoinositol into the maternal circulation is used to establish the degree of transplacental flux of these 2 carbohydrates and to determine if there is evidence of fetal and/or placental production of either of these substrates.

  Measured at time of cesarean delivery

Study Arms (2)

Part 1: Measurements of maternal and fetal concentrations

PLACEBO COMPARATOR

At the time of the elective cesarean section, a blood sample of 0.5 ml will be obtained from a maternal heated hand vein at the time the umbilical cord is clamped. Then, the umbilical cord will be doubly clamped to isolate a segment. The umbilical artery and vein will be sampled for 0.5 ml of blood. There are no stable isotopes infused. Heating the maternal hand vein allows it to be "arterialized." These patients are separate from those required for the stable isotope studies listed below.

Drug: Placebo

Part 2: Stable Isotope Studies

ACTIVE COMPARATOR

Prior to the elective cesarean section, 2 samples from the patient's heated hand vein are obtained to establish a baseline for the compounds. Next, a primed constant infusion containing the stable isotopes of mannose and myoinositol is begun in a peripheral IV of the mother. This is continued approximately 2 hours until the Cesarean section is complete and the umbilical cord samples are obtained. An additional 3 samples are obtained from the patient's heated hand vein: 1 at the start of the cesarean section, 1 at the time the fetus is delivered, and 1 at the time the umbilical cord samples are obtained.

Drug: Mannose; Drug: Myoinositol

Interventions

Mannose DRUG

A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.

Also known as: D-[U-13C]

Part 2: Stable Isotope Studies

Myoinositol DRUG

A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.

Also known as: D-[U-13C]

Part 2: Stable Isotope Studies

Placebo DRUG

placebo

Part 1: Measurements of maternal and fetal concentrations

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal pregnancy = normal fetal growth by ultrasound, absence of congenital anomalies and no maternal complications.
• IUGR = fetal abdominal circumference \< 2 Standard Deviations for gestational age
• Scheduled for elective Cesarean section for clinical indications.
• Age 18-50

You may not qualify if:

• Presence of maternal infection, chromosomal abnormalities or congenital anomalies
• Multiple pregnancies
• Emergency Cesarean sections
• Diagnosed with Diabetes

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Interventions

Mannose; Inositol

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Sugar Alcohols; Alcohols; Organic Chemicals

Results Point of Contact

• Title: Henry Galan
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Henry Galan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: March 24, 2015
• Study Start: January 1, 2001
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 11, 2021
• Results First Posted: November 11, 2021

Record last verified: 2021-10

Locations

US (1)