Hemoglobin and Hematocrit Values on Perinatal OutcomeNCT06726915
Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome
An observational study of Hemoglobin and Hematocrit Values on Perinatal Outcome, run by Ali Mohamed Mohamed Ammar.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemoglobin and Hematocrit Values on Perinatal Outcome
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Pregnant female with age 18 to 40 year
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal weight measurement- still birth or major morbidity
Measured: Baseline
Secondary outcomes (2)
Maternal needs for iron therapy
Measured: Baseline
. Un-even postpartum period: Failure of lactation- DVT- CS wound complications Postpartum anaemia
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hemoglobin and Hematocrit Values on Perinatal OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 403 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ali Mohamed Mohamed Ammar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Mohamed Mohamed Ammar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726915
- Sponsor's protocol ID
- Anemia with pregnancy
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15883455Blankson 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.
PubMed 8441188Lu 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.
PubMed 1988879Breymann 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.
PubMed 20577752Pfeiffer 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.
PubMed 29070545
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Maternal Hemoglobin and Hematocrit Values on Perinatal Outcome
- ClinicalTrials.gov ID
- NCT06726915
- Acronym / sponsor ID
- Anemia with pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 403 participants (estimated)
- Lead sponsor
- Ali Mohamed Mohamed AmmarUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant female with age 18 to 40 year
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fetal weight measurement- still birth or major morbidity
Time frame: Baseline
2 secondary outcomes
Maternal needs for iron therapy
Time frame: Baseline
. Un-even postpartum period: Failure of lactation- DVT- CS wound complications Postpartum anaemia
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Results publication: PubMed 15883455Scholl 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.
- Results publication: PubMed 8441188Blankson 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.
- Results publication: PubMed 1988879Lu 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.
- Results publication: PubMed 20577752Breymann 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.
- Results publication: PubMed 29070545Pfeiffer 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemoglobin and Hematocrit Values on Perinatal Outcome, run by Ali Mohamed Mohamed Ammar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Mohamed Ammar, Graduate (0201032760152, aliammar2237@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal weight measurement- still birth or major morbidity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06726915, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.