NCT02420743

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 20, 2015

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 2, 2021

Status Verified

January 1, 2021

Enrollment Period

6.8 years

First QC Date

April 11, 2015

Last Update Submit

January 30, 2021

Conditions

Preterm Delivery

Keywords

PTD

Outcome Measures

Primary Outcomes (1)

  • High serum ferritin concentration

    The investigators will assess high serum ferritin concentration during third trimester and its effect on pregnancy outcome.

    at 26 to 34 weeks gestation

Secondary Outcomes (2)

  • PSV in fetal MCA doppler

    26 to 34 weeks gestation

  • Preterm delivery

    From 34 to 37 weeks gestation

Interventions

serum ferritinPROCEDURE

serum ferritin will be measured serially at 26, 30 and 34 weeks gestation.

MCA DopplerPROCEDURE

MCA peak systolic value will be assessed at 26, 30 and 34 weeks gestation.

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant females during third trimester. Women should be diagnosed as having iron deficiency anemia.

You may qualify if:

  • Pregnant female from 24 weeks till 37 weeks gestation.
  • Patients diagnosed as iron deficiency anemia.

You may not qualify if:

  • Medical disorders as hypertension or diabetes.
  • Kidney and liver diseases.
  • Any other causes of anemia as haemoglobinopathies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nesreen Abdel Fattah Abdullah Shehata

Cairo, Fostat, 12412, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 9829872BACKGROUND

  • Mari 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.

    PMID: 10620643BACKGROUND

  • Stock 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.

    PMID: 35172391RESULT

  • Royal college of obstetricians and gynecologists. Preterm Prelabour Rupture of Membranes. Green-top Guideline No. 44. London: RCOG Press; 2010.

    RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Nesreen A Shehata, MD

    Beni-Suef University

    STUDY DIRECTOR

Central Study Contacts

Nesreen A Shehata, MD

CONTACT

00201024150605nesoomar@yahoo.com

Abdelgany M Hassan, MD

CONTACT

00201017801604abdelgany2@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 11, 2015

First Posted

April 20, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

February 2, 2021

Record last verified: 2021-01

Locations

EG(1)