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Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome

NCT ID: NCT06726915

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-31

Study Completion Date

2026-05-31

Brief Summary

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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

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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.

Conditions

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Hemoglobin and Hematocrit Values on Perinatal Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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. -
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ali Mohamed Mohamed Ammar

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Mohamed Ammar

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Ali Mohamed Ammar, Graduate

Role: CONTACT

Phone: 0201032760152

Email: [email protected]

Hassan Salah Kamel

Role: CONTACT

Phone: +20 1006664910

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 15883455 (View on PubMed)

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.

Reference Type RESULT
PMID: 8441188 (View on PubMed)

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.

Reference Type RESULT
PMID: 1988879 (View on PubMed)

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.

Reference Type RESULT
PMID: 20577752 (View on PubMed)

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.

Reference Type RESULT
PMID: 29070545 (View on PubMed)

Other Identifiers

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Anemia with pregnancy

Identifier Type: -

Identifier Source: org_study_id