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

Preterm Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03205020
• Other study ID #: amyloid a
• Status: Recruiting
• Phase: N/A
• First received: June 13, 2017
• Last updated: June 30, 2017
• Start date: July 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: June 2017
• Source: Ain Shams University
• Contact: mona cairo nematallah, MS
• Phone: 01061490044
• Email: drmonanematallah11[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
mona nematallah

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	neonatal complications	preterm baby will be examined at neonatal intensive care unit by neonatologist.; • Admission to Neonates intensive care unit.	6 months