Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome

December 9, 2024 updated by: Ali Mohamed Mohamed Ammar
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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

403

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Pregnant female with age 18 to 40 year

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fetal weight measurement- still birth or major morbidity
Time Frame: Baseline
Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ali Mohamed Mohamed Ammar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Estimated)

December 10, 2024

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Anemia with pregnancy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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