Trial Outcomes & Findings for Once Versus Twice Daily Iron Supplementation in Pregnant Women (NCT NCT02839096)
NCT ID: NCT02839096
Last Updated: 2024-09-19
Results Overview
Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one. Postpartum day 1 hemoglobin was estimated from hematocrit by dividing by 2.941.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Change in hemoglobin from baseline to one day postpartum
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Once Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Placebo: Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
Twice Daily Dosing
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
9
|
|
Overall Study
GI Questionnaire Data
|
10
|
9
|
|
Overall Study
Delivery Data
|
10
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One subject in the "Once Daily Dosing" delivered at a separate institution, so there is no delivery data for her.
Baseline characteristics by cohort
| Measure |
Once Daily Dosing
n=11 Participants
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Placebo: Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
Twice Daily Dosing
n=9 Participants
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.545 years
STANDARD_DEVIATION 3.959 • n=11 Participants
|
29.333 years
STANDARD_DEVIATION 3.905 • n=9 Participants
|
27.250 years
STANDARD_DEVIATION 4.290 • n=20 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=11 Participants
|
9 Participants
n=9 Participants
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
1 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=11 Participants
|
7 Participants
n=9 Participants
|
17 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=11 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=20 Participants
|
|
Baseline Hemoglobin
|
10.300 g/dL
STANDARD_DEVIATION 0.645 • n=10 Participants • One subject in the "Once Daily Dosing" delivered at a separate institution, so there is no delivery data for her.
|
11.000 g/dL
STANDARD_DEVIATION 1.079 • n=9 Participants • One subject in the "Once Daily Dosing" delivered at a separate institution, so there is no delivery data for her.
|
10.632 g/dL
STANDARD_DEVIATION 0.924 • n=19 Participants • One subject in the "Once Daily Dosing" delivered at a separate institution, so there is no delivery data for her.
|
|
Baseline Hematocrit
|
30.790 percent
STANDARD_DEVIATION 1.608 • n=10 Participants • One subject in the "Once Daily Dosing" delivered at a separate institution, so there is no delivery data for her.
|
32.480 percent
STANDARD_DEVIATION 2.688 • n=9 Participants • One subject in the "Once Daily Dosing" delivered at a separate institution, so there is no delivery data for her.
|
31.590 percent
STANDARD_DEVIATION 2.292 • n=19 Participants • One subject in the "Once Daily Dosing" delivered at a separate institution, so there is no delivery data for her.
|
PRIMARY outcome
Timeframe: Change in hemoglobin from baseline to one day postpartumPopulation: One participant delivered at another hospital and so baseline, but not delivery or postpartum hemoglobin measurements were obtained.
Maternal Hemoglobin will be measured at baseline, at the time of admission for labor and delivery and on post partum day one. Postpartum day 1 hemoglobin was estimated from hematocrit by dividing by 2.941.
Outcome measures
| Measure |
Once Daily Dosing
n=11 Participants
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Placebo: Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
Twice Daily Dosing
n=9 Participants
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
|---|---|---|
|
Hemoglobin
change in hemoglobin from baseline to delivery
|
0.51 g/dL
Interval 0.0176 to 1.002
|
0.656 g/dL
Interval -0.054 to 1.365
|
|
Hemoglobin
baseline hemoglobin
|
10.264 g/dL
Interval 9.895 to 10.632
|
11.000 g/dL
Interval 10.3622 to 11.638
|
|
Hemoglobin
hemoglobin at delivery
|
10.810 g/dL
Interval 10.465 to 11.155
|
11.656 g/dL
Interval 11.077 to 12.235
|
|
Hemoglobin
estimated postpartum hemoglobin
|
10.105 g/dL
Interval 9.749 to 10.462
|
10.431 g/dL
Interval 9.629 to 11.233
|
|
Hemoglobin
change in hemoglobin from baseline to postpartum day 1
|
-0.195 g/dL
Interval -0.457 to 0.067
|
-0.569 g/dL
Interval -1.392 to 0.254
|
PRIMARY outcome
Timeframe: From enrollment to delivery, which will be an average of 10-12 weeksRecord the incidence of gastrointestinal side effects (i.e. constipation, upset stomach) as measured by a validated questionnaire.
Outcome measures
| Measure |
Once Daily Dosing
n=10 Participants
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Placebo: Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
Twice Daily Dosing
n=9 Participants
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
|---|---|---|
|
Incidence of Gastrointestinal Side Effects (i.e. Constipation, Upset Stomach) as Measured by a Validated Questionnaire
|
1.900 symptoms
Interval 0.828 to 2.972
|
1.222 symptoms
Interval 0.254 to 2.19
|
SECONDARY outcome
Timeframe: At deliveryThe number of patients who received a blood product transfusion at delivery.
Outcome measures
| Measure |
Once Daily Dosing
n=10 Participants
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Placebo: Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
Twice Daily Dosing
n=9 Participants
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
|---|---|---|
|
Incidence of Blood Transfusion at Delivery
|
1 participants
|
0 participants
|
Adverse Events
Once Daily Dosing
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Twice Daily Dosing
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Once Daily Dosing
n=11 participants at risk
Randomized to 325mg of ferrous sulfate in the morning and placebo in the evening
Placebo: Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
Twice Daily Dosing
n=9 participants at risk
Randomized to 325mg of ferrous sulfate in the morning and 325mg of ferrous sulfate in the evening
Ferrous Sulfate: Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
|
|---|---|---|
|
Gastrointestinal disorders
mild gastrointestinal symptoms
|
54.5%
6/11 • Data were collected between enrollment and delivery, approximately 12 weeks.
A questionnaire was administered to assess gastrointestinal symptoms. The incidence of one or more of nausea, hearburn, or abdominal pain is reported as a non-serious adverse event.
|
55.6%
5/9 • Data were collected between enrollment and delivery, approximately 12 weeks.
A questionnaire was administered to assess gastrointestinal symptoms. The incidence of one or more of nausea, hearburn, or abdominal pain is reported as a non-serious adverse event.
|
Additional Information
Research Success Core
University of Missouri School of Medicine
Phone: (573) 817-3386
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place