Trial Outcomes & Findings for Iron Parameters in Non-anemic First Trimester Gravidas (NCT NCT03670537)
NCT ID: NCT03670537
Last Updated: 2019-06-26
Results Overview
Either low serum ferritin or low percent transferrin saturation (TSAT)
Recruitment status
COMPLETED
Target enrollment
102 participants
Primary outcome timeframe
Day 1 presentation to obstetrician
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
First Trimester Pregnant Women
Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
First Trimester Pregnant Women
Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
First Trimester Pregnant Women
n=101 Participants
Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=101 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=101 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=101 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=101 Participants
|
|
Region of Enrollment
United States
|
101 Participants
n=101 Participants
|
|
Gravidity (number of pregnancies)
Gravida 1
|
29 Participants
n=101 Participants
|
|
Gravidity (number of pregnancies)
Gravida 2
|
30 Participants
n=101 Participants
|
|
Gravidity (number of pregnancies)
Gravida 3
|
23 Participants
n=101 Participants
|
|
Gravidity (number of pregnancies)
Gravida 4
|
11 Participants
n=101 Participants
|
|
Gravidity (number of pregnancies)
Gravida 5
|
6 Participants
n=101 Participants
|
|
Gravidity (number of pregnancies)
Gravida 6 or more
|
2 Participants
n=101 Participants
|
PRIMARY outcome
Timeframe: Day 1 presentation to obstetricianEither low serum ferritin or low percent transferrin saturation (TSAT)
Outcome measures
| Measure |
First Trimester Pregnant Women
n=101 Participants
Iron parameters: Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
|
|---|---|
|
Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity
Serum ferritin 25-30ng/ml
|
9 Participants
|
|
Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity
Serum ferritin 20-25ng/ml
|
3 Participants
|
|
Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity
Serum ferritin <20ng/ml
|
6 Participants
|
|
Percent of Non-anemic Patients With Iron Deficiency Stratified by Gravidity
TSAT <19%
|
38 Participants
|
Adverse Events
First Trimester Pregnant Women
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