Trial Outcomes & Findings for Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial (NCT NCT03438227)

NCT ID: NCT03438227

Last Updated: 2024-06-11

Results Overview

Number of participants with maternal hemoglobin \<11g/dl at delivery

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 38 participants
• Primary outcome timeframe: At delivery
• Results posted on: 2024-06-11

Participant Flow

Participant milestones

Measure	Intravenous Iron Dextran Infusion Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Overall Study STARTED	20	18
Overall Study COMPLETED	10	13
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Measure	Intravenous Iron Dextran Infusion Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Overall Study Withdrawal by Subject	10	5

Baseline Characteristics

Intravenous Iron for Iron-deficiency Anemia in Pregnancy: a Randomized Controlled Trial

Baseline characteristics by cohort

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily	Total n=23 Participants Total of all reporting groups
Age, Continuous	26 years n=5 Participants	28 years n=7 Participants	28 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	13 participants n=7 Participants	23 participants n=5 Participants
Chronic hypertension	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Prepregnancy diabetes	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Nulliparous	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Prior preterm birth (<37 weeks' gestation)	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: At delivery

Number of participants with maternal hemoglobin <11g/dl at delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Maternal Anemia at Delivery	4 Participants	11 Participants

SECONDARY outcome

Timeframe: On admission to inpatient obstetrics unit for delivery

Maternal hemoglobin on admission to inpatient obstetrics unit for delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Maternal Hemoglobin at Delivery	11.0 g/dL Standard Deviation 0.7	9.9 g/dL Standard Deviation 1.1

SECONDARY outcome

Timeframe: 2 - 3 days after single intravenous iron infusion or initiation of oral iron

Participants reporting symptoms when contacted by via telephone 2 - 3 days after their infusion of intravenous iron or initiation of oral iron

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Number of Participants With Medication Adverse Events Severe	0 Participants	0 Participants
Number of Participants With Medication Adverse Events Mild/moderate	3 Participants	3 Participants

SECONDARY outcome

Timeframe: At delivery

Number of participants with hemoglobin below 10g/dl at delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Maternal Hemoglobin Below 10g/dl at Delivery	1 Participants	7 Participants

SECONDARY outcome

Timeframe: At delivery

Maternal serum ferritin level in μg/L at delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Maternal Ferritin at Delivery	129.8 μg/L Standard Deviation 117.2	26.6 μg/L Standard Deviation 14.6

SECONDARY outcome

Timeframe: During inpatient admission for delivery of neonate

Participant receiving transfusion of packed red blood cells during admission for delivery of infant obtained via medical chart review.

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Number of Participants Who Received Blood Transfusion	0 Participants	2 Participants

SECONDARY outcome

Timeframe: Once, at infant delivery

Whether infant was delivered vaginally or via cesarean section

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Mode of Delivery Vaginal delivery	4 Participants	8 Participants
Mode of Delivery Cesarean delivery	6 Participants	5 Participants

SECONDARY outcome

Timeframe: Once, at infant delivery

Gestational age in weeks at delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Gestational Age at Delivery	38.1 weeks Standard Deviation 1.0	36.9 weeks Standard Deviation 2.3

SECONDARY outcome

Timeframe: Obtained once, at infant delivery

Neonatal weight at delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Birth Weight	3174.0 grams Standard Deviation 657.2	3029.2 grams Standard Deviation 550.5

SECONDARY outcome

Timeframe: Drawn once from umbilical cord segment at delivery

Umbilical cord arterial pH obtained at delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=9 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Umbilical Cord Arterial pH	7.24 Unitless Standard Deviation 0.09	7.29 Unitless Standard Deviation 0.05

SECONDARY outcome

Timeframe: Obtained at 1 minute of life

The APGAR score, named after the Virginia Apgar, pediatrician who came up with it, measures the physical condition of a newborn infant on a scale ranging from a minimum of 0 (worsts) to a maximum of 10 (best).

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
APGAR Scores at 1 Minutes of Life	8 score on a scale Interval 8.0 to 8.0	8 score on a scale Interval 8.0 to 8.0

SECONDARY outcome

Timeframe: Drawn once from umbilical cord segment at birth

Neonatal hemoglobin in g/dl at delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Neonatal Hemoglobin	13.4 g/dL Standard Deviation 3.4	13.5 g/dL Standard Deviation 2.1

SECONDARY outcome

Timeframe: At birth

Neonatal morbidity composite, defined by the occurrence of one or more of the following neonatal morbidities: neonatal seizures (diagnosed by clinician), intraventricular hemorrhage (diagnosed by clinician on brain MRI or Ultrasound), hypoxic-ischemic encephalopathy (diagnosed by clinician), neonatal hypothermic therapy (brain cooling as documented on inpatient record, sepsis (diagnosed by blood culture), respiratory distress syndrome (diagnosed by clinician), hyperbilirubinemia requiring photo therapy (diagnosed by clinician), birth injury (diagnosed by clinician), or meconium aspiration syndrome (diagnosed by clinician), neonatal intensive care unit admission (documented in the inpatient record).

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Composite Neonatal Morbidity (Defined by the Occurrence of One or More of 10 Neonatal Morbidities.	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Drawn once from umbilical cord segment at birth

Neonatal ferritin in ug/L at delivery

Outcome measures

Measure	Intravenous Iron Dextran Infusion n=10 Participants Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 Participants Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Neonatal Ferritin	169.4 ug/L Standard Deviation 98.2	147.1 ug/L Standard Deviation 69.2

Adverse Events

Intravenous Iron Dextran Infusion

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Oral Ferrous Sulfate Supplementation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Intravenous Iron Dextran Infusion n=10 participants at risk Women randomized to receive intravenous iron infusion will receive a single infusion of dextran 1000mg IV as an inpatient on the antepartum or Labor \& Delivery Unit. They will receive continuous fetal monitoring for 30 minutes before and after the infusion as well for the duration of the infusion Iron dextran: Single intravenous infusion of iron dextran 1000mg.	Oral Ferrous Sulfate Supplementation n=13 participants at risk Women randomized to continue oral iron will continue to take ferrous sulfate 325mg one to three tablets daily, with the final dose at the discretion of the patient's obstetric provider. Ferrous sulfate 325mg: Oral iron supplementation with ferrous sulfate 325mg one to three times daily
Gastrointestinal disorders Constipation	30.0% 3/10 • Number of events 3 • 2 - 3 days after the single intravenous iron infusion or initiation of oral iron	15.4% 2/13 • Number of events 2 • 2 - 3 days after the single intravenous iron infusion or initiation of oral iron
Gastrointestinal disorders Nausea/vomiting	0.00% 0/10 • 2 - 3 days after the single intravenous iron infusion or initiation of oral iron	7.7% 1/13 • Number of events 1 • 2 - 3 days after the single intravenous iron infusion or initiation of oral iron

Additional Information

Dr. Methodius Tuuli

Brown University

Phone: 401-430-1575

Email: MTuuli@wihri.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place