Ultrasonographic Evaluation of Fetal Adrenal Gland in Cases of Threatened Preterm Labor

June 26, 2018 updated by: Ahmed Mohamed Abbas, Assiut University

Preterm birth continues to be a major public health problem with lasting family and societal repercussions. Despite tremendous research effort, prevention strategies have failed, and the prevalence of preterm birth in the United States reached 12.3% in 2003.

Prematurity causes 70% of fetal/neonatal deaths. 11.4% of births are at < 37 weeks' gestation. The rate of prematurity increases dramatically with the number of fetuses - singletons 10%; twins 54.9%; and triplets 93.6%

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut Faculty of Medicine

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
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

women with threatened preterm labor

Description

Inclusion Criteria:

  1. singleton fetus less than 37 weeks of gestation

  2. women diagnosed to having Threatened preterm labor.

    1. presence of uterine contraction (at least 4 in 20 min or 8 in 60 min )
    2. cervical effacement <80 %
    3. cervical dilatation <1 cm

Exclusion Criteria:

  1. suspected fetal growth restriction,
  2. maternal medical complications,
  3. presence of fetal heart rate abnormalities at enrollment.
  4. Preterm Premature rupture of membranes
  5. Placenta previa
  6. Lower urinary tract infection or genital infection
  7. Fetal congenital anomaly

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
threatened preterm labor
women presented to the reception unit from 28-37 weeks by regular contractions and opened cervix
Diagnostic test: three dimensional ultrasound
evaluation of the suprarenal glands
Diagnostic test: color Doppler
Doppler evaluation of the suprarenal artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the volume of adrenal gland
Time Frame: 5 minutes
measurement by three dimensional ultrasound
5 minutes

Collaborators and Investigators

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

Sponsor

Assiut University

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 (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

March 15, 2018

Study Completion (ACTUAL)

April 18, 2018

Study Registration Dates

First Submitted

August 13, 2017

First Submitted That Met QC Criteria

August 13, 2017

First Posted (ACTUAL)

August 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 26, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAGE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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