Trial Outcomes & Findings for Transplacental Gradients and Transport in Intrauterine Growth Restricted (IUGR) Pregnancies Compared to Normal Pregnancies. (NCT NCT02397291)
NCT ID: NCT02397291
Last Updated: 2021-11-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Measured at time of cesarean delivery
Results posted on
2021-11-11
Participant Flow
Participant milestones
| Measure |
Placebo/Control Group
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.
Placebo: placebo
|
Study Group (IUGR)
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.
Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
5
|
|
Overall Study
COMPLETED
|
19
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transplacental Gradients and Transport in Intrauterine Growth Restricted (IUGR) Pregnancies Compared to Normal Pregnancies.
Baseline characteristics by cohort
| Measure |
Placebo/Control Group
n=19 Participants
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.
Placebo: placebo
|
Study Group (IUGR)
n=5 Participants
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.
Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at time of cesarean deliveryThe 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.
Outcome measures
| Measure |
Placebo/Control Group
n=19 Participants
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.
Placebo: placebo
|
Study Group (IUGR)
n=5 Participants
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.
Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
|
|---|---|---|
|
Maternal Enrichment of Mannose
|
63.8429 G/DL
Standard Deviation 7.85
|
78.5 G/DL
Standard Deviation 1.97
|
PRIMARY outcome
Timeframe: Measured at time of cesarean deliveryThe 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.
Outcome measures
| Measure |
Placebo/Control Group
n=19 Participants
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.
Placebo: placebo
|
Study Group (IUGR)
n=5 Participants
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.
Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
|
|---|---|---|
|
Fetal Enrichment of Mannose
|
58.54 G/DL
Standard Deviation 20.1
|
76.50 G/DL
Standard Deviation 8.02
|
PRIMARY outcome
Timeframe: Measured at time of cesarean deliveryThe 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.
Outcome measures
| Measure |
Placebo/Control Group
n=10 Participants
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.
Placebo: placebo
|
Study Group (IUGR)
n=3 Participants
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.
Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
|
|---|---|---|
|
Maternal Enrichment of Myoinositol
|
58.543 G/DL
Standard Deviation 19.1
|
76.5 G/DL
Standard Deviation 6.55
|
PRIMARY outcome
Timeframe: Measured at time of cesarean deliveryThe 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.
Outcome measures
| Measure |
Placebo/Control Group
n=10 Participants
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.
Placebo: placebo
|
Study Group (IUGR)
n=3 Participants
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.
Mannose: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
Myoinositol: A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
|
|---|---|---|
|
Fetal Enrichment of Myoinositol
|
66.8 G/DL
Standard Deviation 17.25
|
59.4 G/DL
Standard Deviation 21.9
|
Adverse Events
Part 1: Measurements of Maternal and Fetal Concentrations
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: Stable Isotope Studies
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place