NCT02694367

Brief Summary

The present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK protein in human placenta and their corresponding tissue, to assess the significance of MAPK signal pathway in progression of recurrent miscarriage and PI3K-Akt Pathway.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
Last Updated

February 29, 2016

Status Verified

February 1, 2016

Enrollment Period

11 months

First QC Date

February 24, 2016

Last Update Submit

February 26, 2016

Conditions

Recurrent Miscarriage

Keywords

genetic basis

Outcome Measures

Primary Outcomes (1)

  • The levels of ERK and AKT in placenta

    48 hours

Study Arms (2)

Recurrent miscarriage group

Women with previous history of RM, defined as two or more consecutive miscarriages

Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins

Control group

Women with no history of RM

Other: Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins

Interventions

Investigate the MAP kinase signaling pathways through ERK and p-ERK proteinsOTHER
Control groupRecurrent miscarriage group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women fulfilling the eligibility criteria had been tested and complete history and examination was done

You may qualify if:

  • Gestational age less than 12 weeks.
  • no uterine abnormalities (examined by ultrasonography or hysterosonogram)
  • previous history of RM, defined as two or more consecutive miscarriages

You may not qualify if:

  • Gestational age 12 weeks or more.
  • Endocrine etiology like (thyroid dysfunction, and uncontrolled diabetes mellitus).
  • Antiphospholipid syndrome, inherited thrombophilias, alloimmune causes.
  • Uterine anatomic anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abbas

Assiut, Cairo Governorate, 002, Egypt

Location

MeSH Terms

Conditions

Abortion, Habitual

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 24, 2016

First Posted

February 29, 2016

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

February 29, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)