Trial Outcomes & Findings for Intravaneous Iron(1000 mg Low Molecular Weight Iron Dextran Over 60 Minutes) for Pregnant Women (NCT NCT02038023)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

4 weeks after infusion or post-partum

Results posted on

2018-06-28

Participant Flow

Standard referrals from obstetricians and gynecologists

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.

Participant milestones

Participant milestones
Measure	IV Iron Intravaneous iron(1000 mg low molecular weight iron dextran over 60 minutes) for moderate to severe iron deficient anemia of pregnancy in women intolerant of or unresponsive to oral iron. Intravaneous iron(low molecular weight iron dextran): 1000 mg of Iron dextran administered over one hour
Overall Study STARTED	74
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Iron n=74 Participants 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
Age, Continuous	24 years n=74 Participants
Sex/Gender, Customized All female	74 Participants n=74 Participants
Region of Enrollment United States	74 participants n=74 Participants
Pretreatment Hb	9.65 g/dL STANDARD_DEVIATION 0.70 • n=74 Participants
Iron Deficient Pregnant Gravidas	74 Participants n=74 Participants
Serum ferritin	14.53 ng/mL STANDARD_DEVIATION 24.61 • n=74 Participants
Percent Transferrin Saturation	11.72 percent saturation (Fe/TIBC) STANDARD_DEVIATION 9.14 • n=74 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Iron Deficient Gravidas n=60 Participants This has been described twice before. Iron deficient pregnant women in the 2nd and 3rd trimester
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
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 outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Iron Deficient Gravidas n=60 Participants This has been described twice before. Iron deficient pregnant women in the 2nd and 3rd trimester
Serum Ferritin	126.29 ng/mL Standard Deviation 88.48

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Iron Deficient Gravidas n=60 Participants This has been described twice before. Iron deficient pregnant women in the 2nd and 3rd trimester
Percent Transferrin Saturation	22.64 percent saturation (Fe/TIBC) Standard Deviation 12.14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Iron Deficient Gravidas n=74 Participants This has been described twice before. Iron deficient pregnant women in the 2nd and 3rd trimester
Safety as Measured by Number of Adverse Events	6 minor adverse events

Adverse Events

IV Iron

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

Dr Michael AUERBACH

AUERBACH HEMATOLOGY ONCOLOGY ASSOC

Phone: 410-780-4050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place