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The Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamic and Neonatal Outcome
| Condition or disease | Intervention/treatment |
|---|---|
| Fetal Conditions | Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C |
Hemoglobin concentration is used to determine the diagnosis and severity of anemia in low resource settings, an indicator that is routinely screened using WHO-defined hemoglobin cutoffs. These thresholds are lower for pregnant women (females ≥ 15 years of age) than non-pregnant women (11.0 g/dl versus 12.0 g/dl). Severity of anemia is determined using additional cutoffs, with severe anemia defined as a hemoglobin level of less than 7.0 g/dl.
Iron deficiency is defined as a condition in which there are no mobilizable iron stores, resulting from a long-term negative iron balance and leading to a compromised supply of iron to the tissues. Finally, the most significant negative consequence of ID is anemia, usually microcytic hypochromic in nature.
IDA has been linked to unfavorable outcomes of pregnancy. It is the most common nutritional disorder in the world affecting two billion people worldwide with pregnant women particularly at risk. According to WHO report, 2001 indicates that IDA is a significant problem throughout the world ranging from 35-75% in developing countries (average 56%) whereas in industrialized countries the average prevalence is 14%.
Distribution of blood flow (between the placental and cerebral regions) is determined with Middle cerebral artery PI/Umbilical artery PI (C/U ratio); this parameter is always > 1.1 during normal pregnancy, but decreases in the case of hypoxia because of umbilical artery resistance index increase (increase in placental resistance) and cerebral resistance index decrease (cerebral vasodilation).
Perinatal morbidity & mortality of IUGR infants is 3-20 times greater than normal infants. These cases may be followed with outpatient monitoring and they often deliver at term. However process is not severe enough to stop fetal growth completely or to deteriorate. The umbilical artery and the middle cerebral artery waveforms may be abnormal, without effect is seen on Doppler and growth until 26-32 weeks gestation; Mild utero-placental insufficiency.
Iron deficiency and iron deficiency anemia during pregnancy are risk factors for preterm delivery, prematurity and small for gestational age birth weight. Iron deficiency has a negative effect on intelligence and behavioral development in the infant. It is essential to prevent iron deficiency in the fetus by preventing iron deficiency in the pregnant woman.
Prevention and control is typically achieved through iron fortification of food staples like flour and rice and/or through administration of iron supplements most often in iron tablets. Although iron supplements are widely available and fortified foods constitute a major component of the diet in the developed world, access is limited in the developing world
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Target Follow-Up Duration: | 3 Months |
| Official Title: | Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamics and Neonatal Outcome |
| Estimated Study Start Date : | July 2019 |
| Estimated Primary Completion Date : | October 2019 |
| Estimated Study Completion Date : | October 2019 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Group A
Patients with mild anemia (Hb concentration: 9.0-10.9 g\dl).
|
Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
Consent, history. US: fetal heart activity, placental site, fetal biometry, AFI, anomalies, Doppler: umbilical artery, MCA, fetal renal artery, C\U ratio. * Maternal Hb,US at time of first visit, 10 days later after initiation of treatment, at EDD .
A: give oral iron in the form of ferrous fumerate with the possible side effects. if Hb returns to normal, continue iron for 3 mon. B: admit to receive IV iron sucrose according to product literature allergic reaction may happen; antiallergic measures. C: give blood transfusion in the form of packed RBC. allergic and pyrogenic reaction and infection may occur. At delivery will be subjected to: examination, investigations, US. Other Name: routine medical care
|
|
Group B
Patients with moderate anemia (Hb concentration: 7.0-8.9 g\dl).
|
Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
Consent, history. US: fetal heart activity, placental site, fetal biometry, AFI, anomalies, Doppler: umbilical artery, MCA, fetal renal artery, C\U ratio. * Maternal Hb,US at time of first visit, 10 days later after initiation of treatment, at EDD .
A: give oral iron in the form of ferrous fumerate with the possible side effects. if Hb returns to normal, continue iron for 3 mon. B: admit to receive IV iron sucrose according to product literature allergic reaction may happen; antiallergic measures. C: give blood transfusion in the form of packed RBC. allergic and pyrogenic reaction and infection may occur. At delivery will be subjected to: examination, investigations, US. Other Name: routine medical care
|
|
Group C
Patients with severe anemia (Hb concentration: >7.0 g\dl).
|
Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
Consent, history. US: fetal heart activity, placental site, fetal biometry, AFI, anomalies, Doppler: umbilical artery, MCA, fetal renal artery, C\U ratio. * Maternal Hb,US at time of first visit, 10 days later after initiation of treatment, at EDD .
A: give oral iron in the form of ferrous fumerate with the possible side effects. if Hb returns to normal, continue iron for 3 mon. B: admit to receive IV iron sucrose according to product literature allergic reaction may happen; antiallergic measures. C: give blood transfusion in the form of packed RBC. allergic and pyrogenic reaction and infection may occur. At delivery will be subjected to: examination, investigations, US. Other Name: routine medical care
|
- Changes in fetal vascular doppler parameters. [ Time Frame: 4 months from June 2019 till October 2019 ]Fetal doppler parameters by resistance index and pulsatility index at first visit and 10 days after recieving treatment and at delivery.
- Neonatal birth weight [ Time Frame: 4 months June 2019 till October 2019 ]Neonatal birth weight in kilograms
| Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Sampling Method: | Non-Probability Sample |
* The pregnant women were divided into three groups:
- Group A : Patients with mild anemia (Hb concentration: 9.0-10.9 g\dl).
- Group B : Patients with moderate anemia (Hb concentration: 7.0-8.9 g\dl).
- Group C : Patients with severe anemia (Hb concentration: >7.0 g\dl).
Inclusion Criteria:
- Pregnant females aged 20- 35 years.
- Gestational age 32 weeks or more.
- Living singleton fetus.
Exclusion Criteria:
- Multifetal pregnancy.
- Patients with chronic illness or medical disorders other than iron deficiency anemia.
- Patients with history of recurrent perinatal deaths or recent blood transfusion or other vitamin deficiency anemia.
| Contact: Mai Assistant lecturer | 01153304548 | maielsayed126@gmail.com | |
| Contact: Ahmad Hamdi, lecturer | 01001980841 | A.hamdi15@yahoo.com |
| Egypt | |
| Kasralainy hospital | |
| Giza, Egypt | |
| Contact: Mai Elsayed, Assistant lecturer 01153304548 maielsayed126@gmail.com | |
| Study Chair: | Muhamad Ehab, professor | Cairo University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 24, 2019 | ||||||||
| First Posted Date | July 12, 2019 | ||||||||
| Last Update Posted Date | July 16, 2019 | ||||||||
| Estimated Study Start Date | July 2019 | ||||||||
| Estimated Primary Completion Date | October 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamic and Neonatal Outcome | ||||||||
| Official Title | Effect of Maternal Iron Deficiency Anemia on Fetal Hemodynamics and Neonatal Outcome | ||||||||
| Brief Summary | This study will be conducted to show the effect of different degrees of maternal iron deficiency anemia on fetal hemodynamics and neonatal outcome and to evaluate the effect of treatment. | ||||||||
| Detailed Description |
Hemoglobin concentration is used to determine the diagnosis and severity of anemia in low resource settings, an indicator that is routinely screened using WHO-defined hemoglobin cutoffs. These thresholds are lower for pregnant women (females ≥ 15 years of age) than non-pregnant women (11.0 g/dl versus 12.0 g/dl). Severity of anemia is determined using additional cutoffs, with severe anemia defined as a hemoglobin level of less than 7.0 g/dl. Iron deficiency is defined as a condition in which there are no mobilizable iron stores, resulting from a long-term negative iron balance and leading to a compromised supply of iron to the tissues. Finally, the most significant negative consequence of ID is anemia, usually microcytic hypochromic in nature. IDA has been linked to unfavorable outcomes of pregnancy. It is the most common nutritional disorder in the world affecting two billion people worldwide with pregnant women particularly at risk. According to WHO report, 2001 indicates that IDA is a significant problem throughout the world ranging from 35-75% in developing countries (average 56%) whereas in industrialized countries the average prevalence is 14%. Distribution of blood flow (between the placental and cerebral regions) is determined with Middle cerebral artery PI/Umbilical artery PI (C/U ratio); this parameter is always > 1.1 during normal pregnancy, but decreases in the case of hypoxia because of umbilical artery resistance index increase (increase in placental resistance) and cerebral resistance index decrease (cerebral vasodilation). Perinatal morbidity & mortality of IUGR infants is 3-20 times greater than normal infants. These cases may be followed with outpatient monitoring and they often deliver at term. However process is not severe enough to stop fetal growth completely or to deteriorate. The umbilical artery and the middle cerebral artery waveforms may be abnormal, without effect is seen on Doppler and growth until 26-32 weeks gestation; Mild utero-placental insufficiency. Iron deficiency and iron deficiency anemia during pregnancy are risk factors for preterm delivery, prematurity and small for gestational age birth weight. Iron deficiency has a negative effect on intelligence and behavioral development in the infant. It is essential to prevent iron deficiency in the fetus by preventing iron deficiency in the pregnant woman. Prevention and control is typically achieved through iron fortification of food staples like flour and rice and/or through administration of iron supplements most often in iron tablets. Although iron supplements are widely available and fortified foods constitute a major component of the diet in the developed world, access is limited in the developing world |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | 3 Months | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population |
* The pregnant women were divided into three groups:
|
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| Condition | Fetal Conditions | ||||||||
| Intervention | Other: Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C
Consent, history. US: fetal heart activity, placental site, fetal biometry, AFI, anomalies, Doppler: umbilical artery, MCA, fetal renal artery, C\U ratio. * Maternal Hb,US at time of first visit, 10 days later after initiation of treatment, at EDD .
A: give oral iron in the form of ferrous fumerate with the possible side effects. if Hb returns to normal, continue iron for 3 mon. B: admit to receive IV iron sucrose according to product literature allergic reaction may happen; antiallergic measures. C: give blood transfusion in the form of packed RBC. allergic and pyrogenic reaction and infection may occur. At delivery will be subjected to: examination, investigations, US. Other Name: routine medical care
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
500 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | October 2019 | ||||||||
| Estimated Primary Completion Date | October 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 20 Years to 35 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | Egypt | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04016922 | ||||||||
| Other Study ID Numbers | Fetal hemodynamics, neonates | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Mai Elsayed Amin, Cairo University | ||||||||
| Study Sponsor | Cairo University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Cairo University | ||||||||
| Verification Date | July 2019 | ||||||||
