Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.
1 other identifier
observational
58
1 country
1
Brief Summary
The aim of the current study is to assess the accuracy of maternal serum amyloid A for prediction of preterm labor in women with threatened preterm labor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2017
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
June 13, 2017
CompletedStudy Start
First participant enrolled
July 1, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJuly 5, 2017
June 1, 2017
6 months
June 13, 2017
June 30, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
prevalence of Amyloid A level in women with preterm labour
venous sample will be taken from each participant from onset of labour, Amyloid a level will be calculated
6 months
Secondary Outcomes (1)
neonatal complications
6 months
Study Arms (2)
women with preterm labor
women delivered at full term
Interventions
* Women who are diagnosed with preterm labor (28-36 weeks) will be enrolled in this study. Serum samples will be collected from all women before any intervention. All women will be sampled once at the time of admission. * Venous blood sample (5 c.c) will be taken from each participant for examination of serum amyloid A. * The collected blood will be centrifuging and serum will be stored to measure the level of amyloid A by (ELISA) technique in clinical pathology department- Ain shams University
Eligibility Criteria
58 pregnant women will be recruited
You may qualify if:
- Pregnant women, age 18 - 35.
- Gestational age: 28 - 36+6 weeks.
- Singleton pregnancy.
- No past history of any medical disorder and with no other medical complications during pregnancy
- Nonsmoker.
- Diagnosis of preterm labor is based on the American College of Obstetricians and Gynecologists Guidelines
- Criteria of preterm delivery:
- Gestational age: 28 - 36+6 weeks
- Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes)
- cervical dilation ≥ 4 cm
- Cervical effacement ≥ 80%.
You may not qualify if:
- Of any patient with the following risk factors for preterm labor:
- Over distended uterus .
- hemorrhage
- Uterine anomalies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- mona nematallahlead
Study Sites (1)
Ain Shams University
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
mona mohamed, MS
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- physician
Study Record Dates
First Submitted
June 13, 2017
First Posted
July 2, 2017
Study Start
July 1, 2017
Primary Completion
January 1, 2018
Study Completion
February 1, 2018
Last Updated
July 5, 2017
Record last verified: 2017-06