NCT02705248

Brief Summary

The objective of this study is to study the association between insulin resistance and recurrent spontaneous miscarriage (RSM).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

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

December 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2016

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

6 months

First QC Date

March 7, 2016

Last Update Submit

March 9, 2016

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • insulin resistance in patients with recurrent miscarriage

    Insulin resistance was determined by measuring fasting Insulin, Fasting glucose, OGTT for all patients. the homeostasis model assessment of insulin resistance index (HOMA-IR) for each subject was calculated

    first trimester of pregnancy

Study Arms (2)

Group A

(Group A) case group: 40 pregnant females at 6- 13wks presenting with a history of recurrent pregnancy loss (two or more failed clinical pregnancies as documented by ultrasonography or histopathology examination according to the American Society of Reproductive Medicine) (ASRM, 2008).

Group B

control group: 40 pregnant females at 6- 13wks with no history of abortion.

Eligibility Criteria

Age23 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant females in their first trimester (6- 13 weeks Gestational Age)

You may qualify if:

  • Women in the child bearing period between 23-40 years.
  • All patients were pregnant.
  • The gestational age of both groups 6-13 weeks(1st trimester)

You may not qualify if:

  • Patients with history of gestational diabetes.
  • The patients on medication that could affect glucose metabolism at the time of the study (as metformin, Pioglitazone,rosiglitazone).
  • Patients with other causes of recurrent abortion as (thyroid dysfunction, uterine anomalies, chromosomal abnormalities, antiphospholipid antibody syndrome).
  • Patients with PCOS in the control group (they have insulin resistance).
  • Obese patients (BMI \>30).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Tarek M Tamara, Dr

    Ain Shams Maternity Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Nermine Essam El-Din Abdel-Salam El-Serwi

Study Record Dates

First Submitted

March 7, 2016

First Posted

March 10, 2016

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Study Completion

March 1, 2016

Last Updated

March 10, 2016

Record last verified: 2016-03