Maternal Serum Amyloid A Levels in Pregnancies Complicated With Preterm Labour.

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.

Study Overview

• Status: Unknown
• Conditions: Preterm Labor
• Intervention / Treatment: Diagnostic test: serum amyloid a test

• Study Type: Observational
• Enrollment (Anticipated): 58

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University
    • Contact: ahmed hussien, MD; Phone Number: 01061460044

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

58 pregnant women will be recruited

Description

Inclusion Criteria:

• 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:

1. Gestational age: 28 - 36+6 weeks
2. Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes)
3. cervical dilation ≥ 4 cm
4. Cervical effacement ≥ 80%.

Exclusion Criteria:

• Of any patient with the following risk factors for preterm labor:

  • Over distended uterus .
  • hemorrhage
  • Uterine anomalies

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
women with preterm labor	Diagnostic test: serum amyloid a test; 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
women delivered at full term	Diagnostic test: serum amyloid a test; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
neonatal complications	preterm baby will be examined at neonatal intensive care unit by neonatologist. • Admission to Neonates intensive care unit.	6 months

Collaborators and Investigators

• Sponsor: mona nematallah
• Investigators: Study Chair: mona mohamed, MS, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: June 13, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 5, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature
• Other Study ID Numbers: amyloid a

Plan for Individual participant data (IPD)

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No