Evaluation the sensitivity and specificity of a novel diagnostic kit for the detection of placental alpha-microglobulin-1 (PAMG-1) in the prediction of preterm birth

Phase 1

Active, not recruiting

• Conditions: Preterm birth; PAMG - 1 positive; PAMG- 1 negative

• Registration Number: TCTR20180703002
• Lead Sponsor: no

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-06-30
• Study Start: 2018-07-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

1. Preterm labour during gesttaional age about 20-36 weeks of gestation.
2. No leakage of amniotic fluid.
3. cervical opening not greater than 3 cm.

Exclusion Criteria

1. Pregnant women less than 18 years old.
2. Pregnant women with leakage of amniotic fluid or bleeding per vagina
3. Pregnant with previous digital examination.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PAMG1 results until delivery Positive and Negative

Secondary Outcome Measures

Name	Time	Method
Preterm birth until delivery Time of delivery