Clinical trial NCT06726915: Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome
Official title: Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hemoglobin and Hematocrit Values on Perinatal Outcome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 403
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant female with age 18 to 40 year

Brief summary: 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.

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:

1. Refusal to participate or consent.
2. Presence of non-iron deficiency anemia (e.g., hemoglobinopathies, chronic disease-related anemia).
3. Multiple pregnancies (e.g., twins or more).
4. Antepartum hemorrhage (e.g., placenta previa, placental abruption).
5. PAS.
6. Malformed fetus. -

Primary outcomes:
measure: Fetal weight measurement- still birth or major morbidity
timeFrame: Baseline
Secondary outcomes:
measure: Maternal needs for iron therapy
timeFrame: Baseline
measure: . Un-even postpartum period: Failure of lactation- DVT- CS wound complications Postpartum anaemia
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.