Preterm DeliverySFMCANCT02420743
Serum Ferritin Concentration and Fetal MCA Doppler as Predictors for Preterm Delivery
An observational study of Preterm Delivery, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Pregnant women with iron deficiency anemia during third trimester will be assessed for serum ferritin and peak systolic value for fetal middle cerebral artery to find out their correlation with preterm delivery. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Preterm Delivery
- What is being tested?
- serum ferritin and MCA Doppler
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant females during third trimester. Women should be diagnosed as having iron deficiency anemia.
Who may be able to join
- Pregnant female from 24 weeks till 37 weeks gestation.
- Patients diagnosed as iron deficiency anemia.
Who cannot join
- Medical disorders as hypertension or diabetes.
- Kidney and liver diseases.
- Any other causes of anemia as haemoglobinopathies.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nesreen Abdel Fattah Abdullah Shehata
Cairo, Fostat, 12412
Nesreen A Shehata, MD, 00201227866337 ext. 02, nesoomar@yahoo.com
Abdelgany M Hassan, MD, 00201017801604 ext. 02, abdelgany2@gmail.com
About this study
Official title: Third Trimester Serum Ferritin Concentration and Fetal MCA Peak Systolic Velocity as Predictors for Preterm Delivery
Pregnant women with iron deficiency anemia during third trimester will be assessed for serum ferritin and peak systolic value for fetal middle cerebral artery to find out their correlation with preterm delivery.
Read the detailed description
Preterm delivery, defined as delivery before 37 weeks of completed gestation (259 days), is a major cause of neonatal morbidity and mortality. Despite extensive research, preterm birth still accounts for 5-10% of all deliveries in developed countries and rates are on the increase, including in the UK. While mortality associated with preterm delivery has declined due to use of antenatal steroids and improvements in neonatal intensive care, preterm babies still remain at risk of major complications. These include respiratory distress syndrome, necrotising enterocolitis, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and long-term cognitive and sensory impairment. Two major determinants for the mortality and morbidity of babies born preterm are gestation at delivery and birthweight. Prematurity therefore carries significant cost implications to both healthcare services and society in general. High hemoglobin along with anemia was examined in an observational study. At entry to care, which ranged between 6 and 8.4 wk gestation, women with hemoglobin levels exceeding 130g/L had a greater than twofold increase in risk of preterm delivery and infant low birth weight. Neither risk was statistically significant, however, because of the small numbers with high hemoglobin. Similarly, a concentration of the iron storage protein, ferritin, that is high for the third trimester of pregnancy is also associated with an increased risk for preterm and very preterm delivery. Over the last twenty years, interest has been shown in using ultrasound parameters or Doppler studies of fetal blood to assess fetal anaemia. Middle cerebral artery Doppler has taken over and has replaced amniocentesis as a screening test for fetal anaemia in high risk pregnancies.
- Conditions
- Preterm Delivery
- Being tested
- serum ferritin, MCA Doppler
- Keywords
- PTD
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum ferritinProcedure or surgery
serum ferritin will be measured serially at 26, 30 and 34 weeks gestation.
MCA DopplerProcedure or surgery
MCA peak systolic value will be assessed at 26, 30 and 34 weeks gestation.
What is being measured
The primary outcome is the main question the study is designed to answer.
High serum ferritin concentration
The investigators will assess high serum ferritin concentration during third trimester and its effect on pregnancy outcome.
Measured: at 26 to 34 weeks gestation
Secondary outcomes (2)
PSV in fetal MCA doppler
Peak systolic velocity of fetal MCA will be measured to diagnose fetal anemia and if correlated with preterm delivery.
Measured: 26 to 34 weeks gestation
Preterm delivery
The investigators will assess pregnancy outcome in the form og preterm delivery with abnormal parameters in the study.
Measured: From 34 to 37 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startOct 2014
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
- Investigators
- Nesreen A Shehata, MD, Study director, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420743
- Sponsor's protocol ID
- Beni-Suef 10
- Acronym
- SFMCA
- Status last verified
- Jan 2021
- First submitted
- 11 Apr 2015
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhou LM, Yang WW, Hua JZ, Deng CQ, Tao X, Stoltzfus RJ. Relation of hemoglobin measured at different times in pregnancy to preterm birth and low birth weight in Shanghai, China. Am J Epidemiol. 1998 Nov 15;148(10):998-1006. doi: 10.1093/oxfordjournals.aje.a009577.
PubMed 9829872Mari G, Deter RL, Carpenter RL, Rahman F, Zimmerman R, Moise KJ Jr, Dorman KF, Ludomirsky A, Gonzalez R, Gomez R, Oz U, Detti L, Copel JA, Bahado-Singh R, Berry S, Martinez-Poyer J, Blackwell SC. Noninvasive diagnosis by Doppler ultrasonography of fetal anemia due to maternal red-cell alloimmunization. Collaborative Group for Doppler Assessment of the Blood Velocity in Anemic Fetuses. N Engl J Med. 2000 Jan 6;342(1):9-14. doi: 10.1056/NEJM200001063420102.
PubMed 10620643Stock SJ, Thomson AJ, Papworth S; Royal College of Obstetricians and Gynaecologists. Antenatal corticosteroids to reduce neonatal morbidity and mortality: Green-top Guideline No. 74. BJOG. 2022 Jul;129(8):e35-e60. doi: 10.1111/1471-0528.17027. Epub 2022 Feb 16. No abstract available.
PubMed 35172391Royal college of obstetricians and gynecologists. Preterm Prelabour Rupture of Membranes. Green-top Guideline No. 44. London: RCOG Press; 2010.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third Trimester Serum Ferritin Concentration and Fetal MCA Peak Systolic Velocity as Predictors for Preterm Delivery
- ClinicalTrials.gov ID
- NCT02420743
- Acronym / sponsor ID
- SFMCA / Beni-Suef 10
- Conditions
- Preterm Delivery
- Keywords
- PTD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Oct 2014
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- 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.
Pregnant women with iron deficiency anemia during third trimester will be assessed for serum ferritin and peak systolic value for fetal middle cerebral artery to find out their correlation with preterm delivery.
Detailed description
Preterm delivery, defined as delivery before 37 weeks of completed gestation (259 days), is a major cause of neonatal morbidity and mortality. Despite extensive research, preterm birth still accounts for 5-10% of all deliveries in developed countries and rates are on the increase, including in the UK. While mortality associated with preterm delivery has declined due to use of antenatal steroids and improvements in neonatal intensive care, preterm babies still remain at risk of major complications. These include respiratory distress syndrome, necrotising enterocolitis, retinopathy of prematurity, sepsis, intraventricular haemorrhage, periventricular leucomalacia and long-term cognitive and sensory impairment. Two major determinants for the mortality and morbidity of babies born preterm are gestation at delivery and birthweight. Prematurity therefore carries significant cost implications to both healthcare services and society in general. High hemoglobin along with anemia was examined in an observational study. At entry to care, which ranged between 6 and 8.4 wk gestation, women with hemoglobin levels exceeding 130g/L had a greater than twofold increase in risk of preterm delivery and infant low birth weight. Neither risk was statistically significant, however, because of the small numbers with high hemoglobin. Similarly, a concentration of the iron storage protein, ferritin, that is high for the third trimester of pregnancy is also associated with an increased risk for preterm and very preterm delivery. Over the last twenty years, interest has been shown in using ultrasound parameters or Doppler studies of fetal blood to assess fetal anaemia. Middle cerebral artery Doppler has taken over and has replaced amniocentesis as a screening test for fetal anaemia in high risk pregnancies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant females during third trimester. Women should be diagnosed as having iron deficiency anemia.
Key inclusion criteria (2 listed)
- Pregnant female from 24 weeks till 37 weeks gestation.
- Patients diagnosed as iron deficiency anemia.
Key exclusion criteria (3 listed)
- Medical disorders as hypertension or diabetes.
- Kidney and liver diseases.
- Any other causes of anemia as haemoglobinopathies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum ferritinserum ferritin will be measured serially at 26, 30 and 34 weeks gestation. | Procedure or surgery | – |
| MCA DopplerMCA peak systolic value will be assessed at 26, 30 and 34 weeks gestation. | Procedure or surgery | – |
Primary outcome
High serum ferritin concentration
Time frame: at 26 to 34 weeks gestation
The investigators will assess high serum ferritin concentration during third trimester and its effect on pregnancy outcome.
2 secondary outcomes
PSV in fetal MCA doppler
Time frame: 26 to 34 weeks gestation
Preterm delivery
Time frame: From 34 to 37 weeks gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Background: PubMed 9829872Zhou LM, Yang WW, Hua JZ, Deng CQ, Tao X, Stoltzfus RJ. Relation of hemoglobin measured at different times in pregnancy to preterm birth and low birth weight in Shanghai, China. Am J Epidemiol. 1998 Nov 15;148(10):998-1006. doi: 10.1093/oxfordjournals.aje.a009577.
- Background: PubMed 10620643Mari G, Deter RL, Carpenter RL, Rahman F, Zimmerman R, Moise KJ Jr, Dorman KF, Ludomirsky A, Gonzalez R, Gomez R, Oz U, Detti L, Copel JA, Bahado-Singh R, Berry S, Martinez-Poyer J, Blackwell SC. Noninvasive diagnosis by Doppler ultrasonography of fetal anemia due to maternal red-cell alloimmunization. Collaborative Group for Doppler Assessment of the Blood Velocity in Anemic Fetuses. N Engl J Med. 2000 Jan 6;342(1):9-14. doi: 10.1056/NEJM200001063420102.
- Results publication: PubMed 35172391Stock SJ, Thomson AJ, Papworth S; Royal College of Obstetricians and Gynaecologists. Antenatal corticosteroids to reduce neonatal morbidity and mortality: Green-top Guideline No. 74. BJOG. 2022 Jul;129(8):e35-e60. doi: 10.1111/1471-0528.17027. Epub 2022 Feb 16. No abstract available.
- Results publicationRoyal college of obstetricians and gynecologists. Preterm Prelabour Rupture of Membranes. Green-top Guideline No. 44. London: RCOG Press; 2010.
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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. This study is not recruiting at the moment.
Nesreen A Shehata, MD study director
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Delivery, run by Beni-Suef University at 1 site in Egypt.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nesreen A Shehata, MD (00201024150605 ext. 02, nesoomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High serum ferritin concentration (time frame: at 26 to 34 weeks gestation). 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 NCT02420743, which also lists 4 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 2 Feb 2021.