Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome

Not yet recruiting

• Conditions: Hemoglobin and Hematocrit Values on Perinatal Outcome

• Registration Number: NCT06726915
• Lead Sponsor: Ali Mohamed Mohamed Ammar

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10
• Study Start: 2025-01
• Primary Completion: 2026-01
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 403

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. -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fetal weight measurement- still birth or major morbidity	Baseline

Secondary Outcome Measures

Name	Time	Method
Maternal needs for iron therapy	Baseline
. Un-even postpartum period: Failure of lactation- DVT- CS wound complications Postpartum anaemia	Baseline