NCT03159234

Brief Summary

Diabetes is the most common medical complication of pregnancy in the united states four to five percent of pregnancies are complicated by diabetes. Pregestational diabetes (diabetes diagnosed before pregnancy, type 1 or type 2 diabetes mellitus) comprises approximately 13 percent of all diabetes in pregnancy, while gestational diabetes ( diabetes with onset or first recognition in pregnancy) comprises the remaining 87 percent . The prevalence of pregestational diabetes has been increasing due to the increasing prevalence of type 2 diabetes in women of reproductive age . The mainstay of the medical management of pregestational diabetes involves frequent monitoring of blood glucose levels with adjustment of diet and insulin therapy to achieve normoglycemia. Normoglycemia is important because maintenance of maternal blood glucose concentration at or near normoglycemic levels decreases the likelihood of adverse pregnancy outcomes, such as miscarriage , congenital anomalies , macrosomia and fetal death.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

May 16, 2017

Last Update Submit

May 17, 2017

Conditions

Fetal Distress

Outcome Measures

Primary Outcomes (1)

  • APGAR score

    5 minutes

Study Arms (1)

Diabetic pregnant women

OTHER
Radiation: fetal lung volumeRadiation: pulmonary artery resistance indexRadiation: Fetal adrenal gland volume:

Interventions

fetal lung volumeRADIATION

the best method for measurement of fetal lung volume is by the rotational technique in which each lung is obtained by serial contouring of the pulmonary area after rotating the volumetric image.this is more recent method seems to have advantages allowing finer contouring of the lung and subsequent modification of the contour as well as being better able to estimate the volumes of irregular and small lung as in congenital diaphragmatic hernia

Diabetic pregnant women
pulmonary artery resistance indexRADIATION

Women placed in semirecumbent position and an axial plane through the fetal thorax to achieve 4 chamber view of the heart. The main pulmonary artery was followed to the point where it divides into right and left branches by rotating the transducer from the 4 chamber view to the short axis view of the heart. Pulsed and colour Doppler was used. The fetal pulmonary artery flow waveform measurements was taken within the proximal portion of the main pulmonary artery

Diabetic pregnant women
Fetal adrenal gland volume:RADIATION

the adrenal gland has a characteristic sonographic appearance; each limb is seen as a long anechoic structure with a thin, echogenic line within its center . Both limbs can sometimes be seen in the coronal plane, and if so there is a strong echogenic line between limbs (probably fat). On the basis of pathologic and histologic studies , we believe the anechoic bulk of the gland represents the fetal zone of the cortex, while the central echogenic core is the medulla.

Diabetic pregnant women

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All pregnant diabetic women
  • weeks gestational age .

You may not qualify if:

  • Women before 37 and after 39 weeks gestational age
  • Pregnancies with known fetal anomalies that may potentially affect the lung maturity .
  • Multiple pregnancies.
  • Women received steroids for lung maturation after ultrasound image acquisition and before delivery .
  • Women with premature rupture of membranes (prom)
  • Pregnancies complicated by medical disorders other than diabetes mellitus .
  • Failure to obtain an informed consent .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Fetal Distress

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of obstetrics and gynecology

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 18, 2017

Study Start

April 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Locations

EG(1)