NCT02088424

Brief Summary

THE INSULIN RESISTANCE IN RECURRENT ABORTION

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2014

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

Study Start

First participant enrolled

March 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

8 months

First QC Date

March 8, 2014

Last Update Submit

March 13, 2014

Conditions

Recurrent Abortion

Outcome Measures

Primary Outcomes (1)

  • fasting blood glucose

    Click here for more information about this study: the role of insulin resistance in recurrent abortion

    3 month

Secondary Outcomes (1)

  • fasting Insulin

    3 month

Other Outcomes (1)

  • oral glucose tolerance test

    3 month

Study Arms (2)

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

insulin resistance(fasting glucose/fasting insulin)OTHER

insulin resistance(fasting glucose/fasting insulin )

GROUP Bgroup A

Eligibility Criteria

Age23 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

1. Women in the child bearing period between 23-40 years. 2. All patients are pregnant. 3. The gestational age of both groups 6-13 weeks

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams maternity hospital

Cairo, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

mohamed a selem, master

CONTACT

00201116724786drghost_3000@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
THE ROLE OF INSULIN RESISTANCE IN RECURRENT MISCARRIAGE

Study Record Dates

First Submitted

March 8, 2014

First Posted

March 17, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2014

Study Completion

April 1, 2015

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

EG(1)