the Insulin Resistance in Recurrent Miscarriage IN RECURR... | NCT02088424

Studies
the Insulin Resistance in Recurrent Miscarriage IN RECURRENT ABORTION

NCT02088424

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Mar 17, 2014Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Recurrent Abortion

Interventions

insulin resistance(fasting glucose/fasting insulin)

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Nov 2014Estimated

Completion Date

Apr 2015Estimated

First Submitted Date

Mar 8, 2014

First Submission Date that Met QC Criteria

Mar 13, 2014

First Posted Date

Mar 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2014

Last Update Posted Date

Mar 17, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

mohamed ahmed selem, THE ROLE OF INSULIN RESISTANCE IN RECURRENT MISCARRIAGE, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A		cases with recurrent abortion with insulin resisance	Other: insulin resistance(fasting glucose/fasting insulin)
GROUP B		cases that are pregnant with no history of recurrent abortion with no insulin resistance	Other: insulin resistance(fasting glucose/fasting insulin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin resistance(fasting glucose/fasting insulin)	Other	insulin resistance(fasting glucose/fasting insulin )	GROUP B group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fasting blood glucose	Click here for more information about this study: the role of insulin resistance in recurrent abortion	3 month

Secondary Outcomes

Measure	Description	Time Frame
fasting Insulin		3 month

Other Outcomes

Measure	Description	Time Frame
oral glucose tolerance test		3 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women in the child bearing period between 23-40 years.
All patients are pregnant.
The gestational age of both groups 6-13 weeks

Exclusion Criteria:

Patients with gestational diabetes and gestational impaired glucose tolerance.
The patients who took medication that could affect glucose metabolism at the time of the study
Patients with other causes of recurrent abortion as(thyroid dysfunction, uterine anomalies chromosomal abnormalities, antiphspholipid antibody syndrome, uterine anomalies and TORCH syndrome).
Patients with PCOS.
Obese patients(BMI>30)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Women in the child bearing period between 23-40 years.
All patients are pregnant.
The gestational age of both groups 6-13 weeks

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
mohamed a selem, master	Contact	00201116724786		drghost_3000@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ain shams maternity hospital		Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D000026	Abortion, Habitual

Ancestor Terms

ID	Term
D000022	Abortion, Spontaneous
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided