Evaluation of the Role of Plasma Procalcitonin in Prediction of Intra-amniotic Infection in Preterm Premature Rupture of Membrane

• Conditions: Intra-amniotic Subclinical Infection.
• Interventions: Drug: procalcitonin

• Registration Number: NCT02104791
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

It is hypothesized that the procalcitonin has a role to play in prediction of intra-amniotic subclinical infection.

Detailed Description

Study population

* This study will be conducted at the department of Obstetrics and Gynecology recruiting pregnant women selected from the attendees of antenatal clinic, emergency department and from inpatient wards of Ain Shams University Maternity Hospital from Mars2014.

* This study will include 100 pregnant women these cases will be divided into 2 groups:

* Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .

* Group 2: Preterm premature rupture of membrane Group: will include 50 pregnant females all at 24-34 weeks of gestational age

Study Timeline

• Status Verified: 2014-04
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-03
• Last Update Submitted: 2014-04-03
• Study First Posted: 2014-04-04
• Last Update Posted: 2014-04-04
• Study Start: 2014-05
• Primary Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
procalcitonin in blood	procalcitonin	-Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .
plasma of blood	procalcitonin	-Group 2: Preterm premature rupture of membrane Group include 50 pregnant women
procalcitonin,prematureruptureofmembrane in blood	procalcitonin	Complete history including (special habits like smoking and alcohol taking, menstrual history especially LMP, medical diseases, past obstetric history including duration, mode of delivery for each pregnancy, and if there were fetal or maternal complications). Physical examination including (general condition, height, weight, vital signs).-Ultrasound to execlude multiple pregnancies, IUFD and to confirm oligohydraminos in group2. The venous blood samples will be taken for measuring of -Procalcitonin in mothors -CRP and WBCs in mothers to detect infection -CRP in neonates of mothers of group 2. They will be asked for their permission and consent.

Primary Outcome Measures

Name	Time	Method
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates.	one year	The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates

Secondary Outcome Measures

Name	Time	Method
Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.	one year	Procalcitonin.; * C-reactive protein.; * White blood cells count (total and diffrantiated).; * C-reactive protein in neonates of groub 2.

Trial Locations

Locations (1)

Ain Shams Maternity Hospital; 🇪🇬 Cairo, Egypt