Trial Outcomes & Findings for Comparison of Two Screening Strategies for Gestational Diabetes (GDM2) (NCT NCT02309138)
NCT ID: NCT02309138
Last Updated: 2020-07-20
Results Overview
birth weight equal to or greater than the 90th percentile for gestational age and sex
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
921 participants
Primary outcome timeframe
at time of delivery
Results posted on
2020-07-20
Participant Flow
Pregnant women were recruited from June 2015 to February 2019 from 10 obstetrical clinics affiliated with Magee Women's Hospital in Pittsburgh,Pennsylvania
Participant milestones
| Measure |
3 Hour 100 gm OGTT (CC Criteria)
Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of \>130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.
Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test
|
2 hr 75 gm OGTT (IADPSG Criteria)
Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the International Association of the Diabetes in Pregnancy Study Group (IADPSG) which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.
Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test
|
|---|---|---|
|
Overall Study
STARTED
|
460
|
461
|
|
Overall Study
COMPLETED
|
412
|
443
|
|
Overall Study
NOT COMPLETED
|
48
|
18
|
Reasons for withdrawal
| Measure |
3 Hour 100 gm OGTT (CC Criteria)
Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of \>130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.
Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test
|
2 hr 75 gm OGTT (IADPSG Criteria)
Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the International Association of the Diabetes in Pregnancy Study Group (IADPSG) which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.
Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
44
|
15
|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
delivered before visit 2
|
0
|
1
|
Baseline Characteristics
participant data missing
Baseline characteristics by cohort
| Measure |
3 Hour 100 gm OGTT (CC Criteria)
n=460 Participants
Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of \>130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.
Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test
|
2 hr 75 gm OGTT (IADPSG Criteria)
n=461 Participants
Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.
Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test
|
Total
n=921 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.8 years
STANDARD_DEVIATION 5.1 • n=460 Participants
|
28.6 years
STANDARD_DEVIATION 5.3 • n=461 Participants
|
28.7 years
STANDARD_DEVIATION 5.2 • n=921 Participants
|
|
Sex: Female, Male
Female
|
460 Participants
n=460 Participants
|
461 Participants
n=461 Participants
|
921 Participants
n=921 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=460 Participants
|
0 Participants
n=461 Participants
|
0 Participants
n=921 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=460 Participants
|
15 Participants
n=461 Participants
|
30 Participants
n=921 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
443 Participants
n=460 Participants
|
445 Participants
n=461 Participants
|
888 Participants
n=921 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=460 Participants
|
1 Participants
n=461 Participants
|
3 Participants
n=921 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=460 Participants
|
0 Participants
n=461 Participants
|
1 Participants
n=921 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=460 Participants
|
18 Participants
n=461 Participants
|
27 Participants
n=921 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=460 Participants
|
2 Participants
n=461 Participants
|
2 Participants
n=921 Participants
|
|
Race (NIH/OMB)
Black or African American
|
161 Participants
n=460 Participants
|
139 Participants
n=461 Participants
|
300 Participants
n=921 Participants
|
|
Race (NIH/OMB)
White
|
249 Participants
n=460 Participants
|
261 Participants
n=461 Participants
|
510 Participants
n=921 Participants
|
|
Race (NIH/OMB)
More than one race
|
26 Participants
n=460 Participants
|
27 Participants
n=461 Participants
|
53 Participants
n=921 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=460 Participants
|
14 Participants
n=461 Participants
|
28 Participants
n=921 Participants
|
|
pre-pregnancy BMI
|
26.6 kg/m2
STANDARD_DEVIATION 6.8 • n=399 Participants • participant data missing
|
26.9 kg/m2
STANDARD_DEVIATION 7.2 • n=428 Participants • participant data missing
|
26.8 kg/m2
STANDARD_DEVIATION 7.0 • n=827 Participants • participant data missing
|
|
Glucose Challenge 50 gm test
|
104.7 mg/dl
STANDARD_DEVIATION 27.7 • n=460 Participants
|
107.8 mg/dl
STANDARD_DEVIATION 28.9 • n=461 Participants
|
106.2 mg/dl
STANDARD_DEVIATION 28.3 • n=921 Participants
|
|
previous history of gestational diabetes
|
8 Participants
n=399 Participants • participant missing data
|
14 Participants
n=429 Participants • participant missing data
|
22 Participants
n=828 Participants • participant missing data
|
|
First degree family history of diabetes
|
97 Participants
n=393 Participants • participant missing data
|
103 Participants
n=415 Participants • participant missing data
|
200 Participants
n=808 Participants • participant missing data
|
PRIMARY outcome
Timeframe: at time of deliverybirth weight equal to or greater than the 90th percentile for gestational age and sex
Outcome measures
| Measure |
Overall IADPSG Arm
n=443 Participants
Participants randomized into the IADPSG arm
|
Overall Carpenter Coustan
n=412 Participants
Participants randomized in the the Carpenter Coustan arm
|
IADPSG With no GDM
n=364 Participants
Participants diagnosed as having no GDM by the IADPSG criteria.
|
Carpenter Coustan With no GDM
n=377 Participants
Participants diagnosed as having no GDM by the Carpenter Coustan criteria
|
|---|---|---|---|---|
|
Large for Gestational Age (LGA) Infant
|
34 Participants
|
35 Participants
|
28 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: at delivery (approximately 40 weeks' gestation)the delivery of a baby through a surgical incision in the mother's abdomen and uterus
Outcome measures
| Measure |
Overall IADPSG Arm
n=449 Participants
Participants randomized into the IADPSG arm
|
Overall Carpenter Coustan
n=423 Participants
Participants randomized in the the Carpenter Coustan arm
|
IADPSG With no GDM
n=365 Participants
Participants diagnosed as having no GDM by the IADPSG criteria.
|
Carpenter Coustan With no GDM
n=377 Participants
Participants diagnosed as having no GDM by the Carpenter Coustan criteria
|
|---|---|---|---|---|
|
Cesarean Delivery
|
131 Participants
|
118 Participants
|
101 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: at delivery (approximately 40 weeks' gestation)maternal pre-eclampsia, 3rd or 4th degree vaginal lacerations, post-partum hemorrhage
Outcome measures
| Measure |
Overall IADPSG Arm
n=442 Participants
Participants randomized into the IADPSG arm
|
Overall Carpenter Coustan
n=425 Participants
Participants randomized in the the Carpenter Coustan arm
|
IADPSG With no GDM
n=365 Participants
Participants diagnosed as having no GDM by the IADPSG criteria.
|
Carpenter Coustan With no GDM
n=379 Participants
Participants diagnosed as having no GDM by the Carpenter Coustan criteria
|
|---|---|---|---|---|
|
Maternal Composite Morbidity
|
77 Participants
|
75 Participants
|
62 Participants
|
63 Participants
|
SECONDARY outcome
Timeframe: 7 days after birth1\) hypoglycemia: blood glucose \< 40mg/dl); 2) hyperbilirubinemia requiring treatment, clinical jaundice; 3)hyperinsulinemia- measured with c peptide level from venous cord blood; 4) still birth- absence of fetal heart tones before delivery, 5) birth trauma= Shoulder dystocia/brachial plexus injuries.
Outcome measures
| Measure |
Overall IADPSG Arm
n=442 Participants
Participants randomized into the IADPSG arm
|
Overall Carpenter Coustan
n=425 Participants
Participants randomized in the the Carpenter Coustan arm
|
IADPSG With no GDM
n=365 Participants
Participants diagnosed as having no GDM by the IADPSG criteria.
|
Carpenter Coustan With no GDM
n=379 Participants
Participants diagnosed as having no GDM by the Carpenter Coustan criteria
|
|---|---|---|---|---|
|
Neonatal Composite Morbidity
|
83 Participants
|
57 Participants
|
57 Participants
|
48 Participants
|
Adverse Events
3 Hour 100 gm OGTT (CC Criteria)
Serious events: 17 serious events
Other events: 154 other events
Deaths: 0 deaths
2 hr 75 gm OGTT (IADPSG Criteria)
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3 Hour 100 gm OGTT (CC Criteria)
n=460 participants at risk
Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of \>130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.
Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test
|
2 hr 75 gm OGTT (IADPSG Criteria)
n=461 participants at risk
Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.
Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.87%
4/460 • Number of events 4 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
0.00%
0/461 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
Nervous system disorders
migraine headache
|
0.22%
1/460 • Number of events 1 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
0.00%
0/461 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
Pregnancy, puerperium and perinatal conditions
heavy vaginal bleeding
|
0.00%
0/460 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
0.22%
1/461 • Number of events 1 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membranes
|
0.22%
1/460 • Number of events 1 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
0.00%
0/461 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
Other adverse events
| Measure |
3 Hour 100 gm OGTT (CC Criteria)
n=460 participants at risk
Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of \>130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.
Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test
|
2 hr 75 gm OGTT (IADPSG Criteria)
n=461 participants at risk
Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.
Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test
|
|---|---|---|
|
Metabolism and nutrition disorders
nausea
|
12.6%
58/460 • Number of events 58 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
4.3%
20/461 • Number of events 20 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
Nervous system disorders
dizziness
|
4.8%
22/460 • Number of events 23 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
0.87%
4/461 • Number of events 4 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
Gastrointestinal disorders
vomiting
|
6.1%
28/460 • Number of events 30 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
2.6%
12/461 • Number of events 12 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
General disorders
Malaise
|
1.7%
8/460 • Number of events 8 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
0.65%
3/461 • Number of events 3 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
Nervous system disorders
Headache
|
0.87%
4/460 • Number of events 4 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
0.87%
4/461 • Number of events 4 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
Pregnancy, puerperium and perinatal conditions
Other
|
0.65%
3/460 • Number of events 3 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
0.22%
1/461 • Number of events 2 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
15.2%
70/460 • Number of events 72 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
4.1%
19/461 • Number of events 21 • Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
|
Additional Information
Director of Center for Research on Health Care Data Center
University of Pittsburgh
Phone: 412-692-2023
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place