Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hemoglobin and Hematocrit Values on Perinatal Outcome. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to evaluate the perinatal outcome in pregnancies with different levels of hemoglobin/hematocrit to verify which category of women should have iron supplementation if not all.
Detailed description
Anaemia in pregnant women has been reported to have various adverse effects on both the mother and unborn foetus. These effects include preterm birth, a low birth weight and an increase in the risk of maternal and perinatal mortality . Postpartum anaemia impairs wound healing, increases the risk for readmission and/or prolonged hospitalization, and increases the cost of care for families .
Some investigators stated adverse perinatal outcome in pregnant mothers with high haemoglobin and haematocrit values and raised a question about the possible harmful effect of iron supplementation in such pregnancies.
Primary outcome measures
- Fetal weight measurement- still birth or major morbidity [Time frame: Baseline]
Secondary outcome measures (2)
- Maternal needs for iron therapy [Time frame: Baseline]
- . Un-even postpartum period: Failure of lactation- DVT- CS wound complications Postpartum anaemia [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 1\. Pregnant women scheduled for labor or C.S (at term, 28-42 weeks). 3. Singleton pregnancy. 4. Age range: 18-40 years. 5. Willing to provide informed consent for participation and follow-up.
Exclusion criteria
- Refusal to participate or consent.
- Presence of non-iron deficiency anemia (e.g., hemoglobinopathies, chronic disease-related anemia).
- Multiple pregnancies (e.g., twins or more).
- Antepartum hemorrhage (e.g., placenta previa, placental abruption).
- PAS.
- Malformed fetus. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Scholl TO. Iron status during pregnancy: setting the stage for mother and infant. Am J Clin Nutr. 2005 May;81(5):1218S-1222S. doi: 10.1093/ajcn/81.5.1218. PMID 15883455
- Blankson ML, Goldenberg RL, Cutter G, Cliver SP. The relationship between maternal hematocrit and pregnancy outcome: black-white differences. J Natl Med Assoc. 1993 Feb;85(2):130-4. PMID 8441188
- Lu ZM, Goldenberg RL, Cliver SP, Cutter G, Blankson M. The relationship between maternal hematocrit and pregnancy outcome. Obstet Gynecol. 1991 Feb;77(2):190-4. doi: 10.1097/00006250-199102000-00005. PMID 1988879
- Breymann C, Honegger C, Holzgreve W, Surbek D. Diagnosis and treatment of iron-deficiency anaemia during pregnancy and postpartum. Arch Gynecol Obstet. 2010 Nov;282(5):577-80. doi: 10.1007/s00404-010-1532-z. Epub 2010 Jun 25. PMID 20577752
- Pfeiffer CM, Looker AC. Laboratory methodologies for indicators of iron status: strengths, limitations, and analytical challenges. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1606S-1614S. doi: 10.3945/ajcn.117.155887. Epub 2017 Oct 25. PMID 29070545
Identifiers
NCT: NCT06726915 · Anemia with pregnancy