Trial Outcomes & Findings for Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment (NCT NCT00746551)
NCT ID: NCT00746551
Last Updated: 2015-02-16
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
3 weeks after intervention
Results posted on
2015-02-16
Participant Flow
This trial was conducted at Maternal Fetal Medicine Unit, Siriraj Hospital between September 2008 and December 2009. Singleton pregnant women aged 18-45 years old at GA of 32 weeks with Hb level \< 11.0 g/dL, serum ferritin levels \< 15 µg/L and CRP of \< 20 mg/L with negative stool examination for parasitic infection were recruited into the study.
Participant milestones
| Measure |
Iron Sucrose, Venofer®, Intravenous Drug
Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
|
Ferrous Fumarate, Ferri-6®, Oral Tablet
In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
|
|---|---|---|
|
At Gestational Age of 36 Weeks
STARTED
|
40
|
40
|
|
At Gestational Age of 36 Weeks
COMPLETED
|
38
|
36
|
|
At Gestational Age of 36 Weeks
NOT COMPLETED
|
2
|
4
|
|
At Delivery (GA of 39 Weeks)
STARTED
|
40
|
40
|
|
At Delivery (GA of 39 Weeks)
COMPLETED
|
25
|
25
|
|
At Delivery (GA of 39 Weeks)
NOT COMPLETED
|
15
|
15
|
Reasons for withdrawal
| Measure |
Iron Sucrose, Venofer®, Intravenous Drug
Women in the IV-group received 500 mg iron sucrose (Venofer®, Vifor International AG, St. Gallen, Switzerland) divided into three weekly administrations. Two doses of 200 mg iron sucrose were given at 33 and 34 weeks gestation while the remaining (100 mg) was infused at gestation of 35 weeks. Thereafter, women in this group received no further iron therapy until delivery. In preparation, 200 mg of iron sucrose was diluted into 100 ml of 0.9% saline solution.
|
Ferrous Fumarate, Ferri-6®, Oral Tablet
In the O-group, women had to take 3 ferrous fumarate tablets (Ferli-6®) everyday with a total of 200 mg of elemental iron per day from 33 weeks gestation until delivery. Emphasizing and monitoring for compliance to the treatment protocol were carried out.
|
|---|---|---|
|
At Gestational Age of 36 Weeks
Lost to Follow-up
|
2
|
4
|
|
At Delivery (GA of 39 Weeks)
Lost to Follow-up
|
9
|
7
|
|
At Delivery (GA of 39 Weeks)
preterm delivery, delivery elesewhere
|
6
|
8
|
Baseline Characteristics
Intravenous Versus Oral Iron in Late Pregnancy: Results of Treatment
Baseline characteristics by cohort
| Measure |
Iron Sucrose, Venofer, Intravenous Drug
n=40 Participants
Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
|
Ferrous Fumarate, Ferri-6, Oral Tablet
n=40 Participants
Initially, there were 194 subjects enrolled but 114 cases were excluded from the study. Among those, 104 cases did not meet the inclusion criteria and 10 cases refused to take part. A total of 80 eligible patients were equally randomised and allocated in to 2 groups of intravenous sucrose complex-group (ISC) and oral ferrous fuamrate-group (OFF) . At GA of 36 weeks, there were 4 cases of the OFF-group and 2 cases of the ISC-group lost to follow-up. At delivery, there were 50 patients remained in the study whereas 30 patients were excluded from statistical analysis due to losing to follow-up (16 cases), delivery at other hospitals (10 cases) and preterm deliveries (4 cases).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
24.9 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
24.6 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body weight
|
48.1 kg
STANDARD_DEVIATION 8.1 • n=5 Participants
|
50.2 kg
STANDARD_DEVIATION 6.6 • n=7 Participants
|
49.2 kg
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Body mass index
|
19.7 kg/sq.m
STANDARD_DEVIATION 3.4 • n=5 Participants
|
20.1 kg/sq.m
STANDARD_DEVIATION 2.2 • n=7 Participants
|
19.9 kg/sq.m
STANDARD_DEVIATION 2.9 • n=5 Participants
|
|
C-reactive protein
|
3.7 mg/L
STANDARD_DEVIATION 2.0 • n=5 Participants
|
4.0 mg/L
STANDARD_DEVIATION 2.3 • n=7 Participants
|
3.9 mg/L
STANDARD_DEVIATION 2.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks after interventionOutcome measures
| Measure |
Iron Sucrose, Venofer, Intravenous Drug
n=38 Participants
Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.
If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.
Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial.
|
Ferrous Fumarate, Ferri-6, Oral Tablet
n=36 Participants
The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
|
|---|---|---|
|
Serum Ferritin Level
|
136.1 µg/dL
Standard Deviation 55.0
|
28.3 µg/dL
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 3 weeks after interventionOutcome measures
| Measure |
Iron Sucrose, Venofer, Intravenous Drug
n=38 Participants
Patients in the study group (ISC-group) were given 500 mg of ISC (Venofer®, Vifor International AG, St. Gallen, Switzerland) in three divided doses. The administration was given weekly with the maximum dose of 200 mg from GA 33 to 35 weeks. Thereafter, no other iron supplementation was given to this group until delivery. In preparation, 200 mg of ISC was diluted into 100 ml of 0.9% saline solution. Test dose was performed by slow infusion of 5 ml solution within 5 minutes. This was only required on the first ISC treatment.
If no adverse reactions were observed in 15 minutes, the remaining solution was infused to the patient within 30 minutes. Subsequent infusions were administered in 40 minutes. Careful post infusion observation was conducted in every case for at least 30 minutes to ensure patient safety.
Patients in the ISC-group who failed to complete the 3-week treatment course were withdrawn from the trial.
|
Ferrous Fumarate, Ferri-6, Oral Tablet
n=36 Participants
The patients in the control group (OFF-group) were instructed to have 3 oral ferrous fumarate tablets (Ferli-6®, Continental-Pharm, Thailand) daily with a total of 200 mg elemental iron per day until delivery. The remaining of OFF tablets was counted at every visit to evaluate patient compliance. Patients in the OFF-group who took less than 80% of the allocated medication were withdrawn from the trial.
|
|---|---|---|
|
Haemoglobin Level
|
10.6 g/dL
Standard Deviation 0.6
|
10.2 g/dL
Standard Deviation 1.0
|
Adverse Events
Iron Sucrose, Venofer®, Intravenous Drug
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ferrous Fumarate, Ferri-6®, Oral Tablet
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
Pharuhas Chanprapaph
Mahidol University, Department of Obstetrics and Gynaecology, Division of Maternal Fetal Medicine, Faculty of Medicine, Siriraj Hospital
Phone: +66819920053
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place