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Status unknownNCT01071759Updated Feb 19, 2010

Effects of Dietary Heme/Non-heme Iron and Helicobacter Pylori (Hp) Infection on Maternal Iron-deficiency Anemia and Fetal Growth Outcomes

An observational study in Pregnancy, Helicobacter Pylori Infection and Iron-Deficiency Anemia, sponsored by E-DA Hospital. Status unknown at 1 site in Taiwan. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-19.

Sponsored by E-DA Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2010), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
140
Sex
Female
01

Study summary

Iron deficiency is considered one of the main nutritional deficiency disorders despite the apparent availability of a high-quality diet even in developed countries, and Iron deficiency anemia (IDA) is the most common form of anemia in the world. IDA during pregnancy has been associated with adverse health consequences for both the mother and her developing fetus. Helicobacter pylori (Hp) may be the most common bacterial infection worldwide, infecting almost half of people in developed countries and 80% of people in developing countries. The available data on the prevalence of Hp infection in Taiwan population was 54.4%. We all know that infection with Hp is strongly associated with peptic ulcer and gastric cancer, but recent evidence suggests that Hp is associated with iron deficiency and anemia, although the mechanisms remain unclear. Till now, only few previous studies specifically have addressed a potential role of Hp infection on anemia or iron deficiency during pregnancy. Our previous Research showed, between the Hp infection (+) and Hp infection (-) gravidas, the associations between the Hp infection and iron deficiency were stronger, although not statistically significant. This might be due to that we needed more cases and evidences to prove the relationship between maternal Hp infection and serum iron, ferritin and hemoglobin levels, or we should further consider the interactions of the particular customs or diet preference of the Taiwanese gravidas. This longitudinal study will recruit 140 women from the antenatal care clinics of E-Da Hospital to examine the association between Hp infection and maternal IDA. The standardized interviews of mothers (anthropometric data, socioeconomic status, medical history, obstetric history, alcohol consumption during pregnancy, and history and duration of iron supplementation during pregnancy) will be conducted, Hp infection status will be determined by the urea breath test and IgG enzyme immunoassay, and the measurement of hemoglobin, iron, and ferritin levels will be obtained 5 times at various antepartum and postpartum points of time during pregnancy (routine prenatal visits of 1st, 2nd, and 3rd trimester, puerperium and 2 weeks after delivery). We hope that we could investigate the possible role of Hp infection in iron deficiency and iron-deficiency anemia during pregnancy in Taiwan, and that early detection and treatment of anemia may reduce the risk of blood transfusion and perinatal and maternal mortality.

02

Conditions studied

  • Pregnancy
  • Helicobacter Pylori Infection
  • Iron-Deficiency Anemia

Keywords

  • Pregnancy
  • anemia
  • Helicobacter pylori
  • Hemoglobin
  • Iron
  • Ferritin
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 140 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

E-DA Hospital is the lead sponsor of 34 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Pregnant Ladies

Inclusion criteria

  • Pregnant Ladies

Exclusion criteria

Exclusion Criteria:

  • Thalassemia
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
140 participants (estimated)

Groups and cohorts

  • pregnancy
06

Study locations

1 of 1 sites recruiting
  • E-DA Hospital
    Kaohsiung County, Taiwan
    • Fu-Chen Kuo, MD, MSc · Contact · ed100418@edah.org.tw · 886-7-6150011
    • Fu-Chen Kuo, MD, Msc · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01071759
Lead sponsor
E-DA Hospital
First posted
Feb 19, 2010
Start date
Feb 2009
Last update
Feb 19, 2010

Study contacts

Fu-Chen Kuo, MD, MSc
Contact
ed100418@edah.org.tw
886-7-6150011 ext. 2981

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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