Pregnancy
Conditions
Keywords
Iv iron in pregnant women, second and third trimester
Brief summary
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed).
Detailed description
To determine the percentage of women who achieve anemia correction after a single dose of 1000mg of low molecular weight iron dextran(infed). To determine whether IV iron supplementation has a higher satisfaction with treatment as compared to oral supplementation in a population previously intolerant of or unresponsive to oral iron. To evaluate the safety of IV low molecular weight iron dextran in pregnant women. To assess maternal and fetal outcomes-preterm delivery, low birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post-partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups.
Interventions
DRUGIntravaneous iron(low molecular weight iron dextran)
1000 mg of Iron dextran administered over one hour
Sponsors
Pharmacosmos A/S
Auerbach Hematology Oncology Associates P C
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* pregnant women intolerable to oral iron. hbg \<10.9 g/dl during second or third trimester.
Exclusion criteria
* known sensitivity to IV iron. hemoglobinopathies. hemolytic anemia. women who have received or will receive blood transfusions. women with significant vaginal bleeding(\>200 cc blood loss)prior to delivery. women with documented history of allergy to more than one class of drug clinically significant anemia requiring therapy in the opinion of the obstetrician, in the first trimester.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). | 4 weeks after infusion or post-partum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Ferritin | 4 weeks post infusion or post-partum | — |
| Percent Transferrin Saturation | 4 weeks post infusion or post-partum | — |
| Safety as Measured by Number of Adverse Events | 4 weeks after infusion and 4 weeks post-partum | To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days. |
Countries
United States
Participant flow
Recruitment details
Standard referrals from obstetricians and gynecologists
Pre-assignment details
Oral iron intolerance plus iron deficiency anemia as defined by a serum ferritin of \<20 ng/mL or transferrin saturation of \<19% in the 2nd or 3rd trimester plus the ACOG guidelines of \<10/.5 g/dL and 11.0 g/dl respectively. 73/74 enrolled received the planned dose.
Participants by arm
| Arm | Count |
|---|---|
| Intravenous Iron As oral iron intolerant iron deficient 2nd and 3rd trimester gravidas defined by a ferritin of \<20 ng/mL and TSAT ,19%. All were anemic by ACOG criteria of Hb \<10.5 g/dL in 2nd trimester or, 11g/dL in 3rd, who received 1000 mg IV low molecular weight iron dextran in one hour | 74 |
| Total | 74 |
Baseline characteristics
| Characteristic | Intravenous Iron | — |
|---|---|---|
| Age, Continuous | 24 years | — |
| Iron Deficient Pregnant Gravidas | 74 Participants | — |
| Percent Transferrin Saturation | 11.72 percent saturation (Fe/TIBC) STANDARD_DEVIATION 9.14 | — |
| Pretreatment Hb | 9.65 g/dL STANDARD_DEVIATION 0.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 74 participants | — |
| Serum ferritin | 14.53 ng/mL STANDARD_DEVIATION 24.61 | — |
| Sex/Gender, Customized All female | 74 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 |
Outcome results
Primary
Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD).
Time frame: 4 weeks after infusion or post-partum
Population: Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iron Deficient Gravidas | Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). | Improvement of > or equal to 1 g/dL | 35 Participants |
| Iron Deficient Gravidas | Percentage of Women Who Achieve Anemia Correction After a Single Dose of 1000mg of Low Molecular Weight Iron Dextran(INfeD). | Improvement of > or equal to 2 g/dL | 11 Participants |
Secondary
Percent Transferrin Saturation
Time frame: 4 weeks post infusion or post-partum
Population: Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iron Deficient Gravidas | Percent Transferrin Saturation | 22.64 percent saturation (Fe/TIBC) | Standard Deviation 12.14 |
Secondary
Safety as Measured by Number of Adverse Events
To evaluate the safety of IV low molecular weight iron dextran in pregnant women. Also to asses maternal and fetal outcomes-preterm delivery, low-birth weight deliveries, ER visits and hospitalizations related to preterm labor, preterm contractions, ante-partum and post partum transfusions, maternal hemoglobin at post-partum visit after IV iron supplementation groups. A questionaire with a list of symptoms to include nausea, dizziness, hypotension, edema, headache, abdominal pain, chest pain, cough, itching, fever, back pain, muscle cramps and rash are asked immediately after administration and phone calls at 24, 48 hours and 7 days.
Time frame: 4 weeks after infusion and 4 weeks post-partum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Iron Deficient Gravidas | Safety as Measured by Number of Adverse Events | 6 minor adverse events |
Secondary
Serum Ferritin
Time frame: 4 weeks post infusion or post-partum
Population: Of the 73 who received the infusion, 5 were lost to followup and 8 did not return for 4-week posttreatment bloodwork. Pretreatment (initial) and 4-week posttreatment laboratory studies are available for 60
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iron Deficient Gravidas | Serum Ferritin | 126.29 ng/mL | Standard Deviation 88.48 |