Diabetes Mellitus With Pregnancy in Benisuef Localities

• Sponsor: Beni-Suef University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03169205
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 100
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal & fetal complications and to predict the risk factors for poor maternal, fetal & neonatal outcomes

Condition or Disease	Intervention/Treatment	Phase
Pregnancy in Diabetics	Other: observation registry

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diabetes Mellitus With Pregnancy in Benisuef Localities
• Actual Study Start Date: May 1, 2017
• Anticipated Primary Completion Date: May 1, 2019
• Anticipated Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
preexisting Diabetes mellitus type 1	Other: observation registry; observation registry
preexisting Diabetes mellitus type 2	Other: observation registry; observation registry
Gestational Diabetes mellitus	Other: observation registry; observation registry

Outcome Measures

Primary Outcome Measures

1. Maternal outcome [2 years]

   No. of patients who have preeclampsia,eclampsia,preterm delivery,Cesarean section,vaginal candidiasis,premature rupture of membrane,polyhydramnios,oligohydramnios,accidental hemorrhage,birth canal injuries,puerperal sepsis,wound infection,postpartum glucose intolerance.

Secondary Outcome Measures

1. fetal outcome [2 years]

   No. of abortion,prematurity,macrosomia,congenital anomalies,intrauterine fetal death,still birth,shoulder dystocia,brachial plexus injury,neonatal death,respiratory distress syndrome,neonatal jaundice requiring photo-therapy,neonatal hypoglycemia,

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• all pregnant ladies with Diabetes mellitus either type 1 or type 2

• all pregnant ladies with glucose intolerance which is first diagnosed during current pregnancy

Exclusion Criteria:

• ladies age less than 18 year or above 45

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Beni-suef		Egypt
2		Beni-suef		Egypt

Sponsors and Collaborators

• Beni-Suef University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Momen Zakaria Mohammed mohammed, assisstant lecturer, Beni-Suef University
• ClinicalTrials.gov Identifier: NCT03169205
• Other Study ID Numbers: 2500
• First Posted: May 30, 2017
• Last Update Posted: May 30, 2017
• Last Verified: May 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Pregnancy in Diabetics; Diabetes Mellitus

Study Results

No Results Posted as of May 30, 2017