NCT03915990

Brief Summary

120 patients will be included and divided into two groups; Control group that will include 60 healthy pregnant women and Study group that will include 60 pregestational diabetic pregnant patients which furtherly will be subdivided into two groups according to HbA1C levels namely; controlled diabetics ( will include 30 diabetic pregnant women with controlled DM - HbA1C \< 6.5 %) and uncontrolled diabetics (will include 30 diabetic pregnant women with uncontrolled DM - HbA1C ≥ 6.5 %). Umbilical and middle cerebral arteries Doppler indices (resistance index and pulsatility index) and Cerebroplacental Doppler ratio will be measured for every patient. The recorded neonatal outcomes will include neonatal birth weight, neonatal blood sugar, Apgar score at 1 \& 5 min and neonatal intensive care unit admission.

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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2019

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

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

April 12, 2019

Last Update Submit

November 7, 2020

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetesumbilical arterymiddle cerebral artery

Outcome Measures

Primary Outcomes (1)

  • the diagnostic value of Umbilical artery Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients.

    the sensitivity \& the specificity of UA RI \& PI in predicting the adverse neonatal outcome among diabetic patients.

    34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)

Secondary Outcomes (1)

  • he diagnostic value of MCA Doppler indices [Resistance index (RI)& pulsatility index (PI)] in predicting the adverse neonatal outcome among diabetic patients.

    34 -37 weeks gestation (for DOPPLER) and at birth (for neonatal outcomes)

Study Arms (3)

control group

OTHER

60 healthy pregnant women will be included

Diagnostic Test: umbilical and middle cerebral artery Doppler

controlled diabetics

ACTIVE COMPARATOR

30 diabetic pregnant women with controlled Diabetes (i.e. HbA1C less than 6.5 %)

Diagnostic Test: umbilical and middle cerebral artery Doppler

uncontrolled diabetics

ACTIVE COMPARATOR

30 diabetic pregnant women with uncontrolled Diabetes (i.e. HbA1C equal or more to 6.5 %)

Diagnostic Test: umbilical and middle cerebral artery Doppler

Interventions

umbilical and middle cerebral artery DopplerDIAGNOSTIC_TEST

Umbilical and middle cerebral arteries Doppler indices (resistance index and pulsatility index) and Cerebroplacental Doppler ratio will be measured for every patient.

control groupcontrolled diabeticsuncontrolled diabetics

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Single living pregnancy.
  • Gestational age: 34-37 weeks (confirmed by a reliable date for the last menstrual period and 1st trimester ultrasound scan).
  • Healthy pregnant women in group 1 (control group).
  • History of pregestational DM in group 2 (study group) i.e., patients known to be diabetic before pregnancy whether on diet, oral hypoglycemic drugs or insulin therapy.

You may not qualify if:

  • Fetal anomalies.
  • Any maternal chronic diseases esp. renal disease, epilepsy or CNS lesion.
  • Pregnancy induced medical disorders.
  • IUGR (EFW below the 10th percentile for gestational age).
  • Rupture of membranes or oligohydramnios (AFI \< the fifth percentile).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kasr elainy hospital (Faculty of Medicine - Cairo University)

Cairo, 115431, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Moutaz El sherbini, MD

CONTACT

01001588300mizosherbini@yahoo.com

mahmoud ismail, MSc

CONTACT

01003457468dr_mahmoud_ahmed2015@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor (MD) Obs & Gyn.

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

July 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)