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

Intra-amniotic Subclinical Infection. Clinical Trial

Official title:

Procalcitonin Has a Role to Play in Prediction of Intra-amniotic Subclinical Infection.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02104791
• Other study ID #: MRCOG-1988
• Status: Enrolling by invitation
• Phase: N/A
• First received: April 2, 2014
• Last updated: April 3, 2014
• Start date: May 2014

Study information

• Verified date: April 2014
• Source: Ain Shams Maternity Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Patients are with singleton pregnancies. Rupture of membranes will be diagnosed by history, sterile speculum examination to confirm fluid leakage from the cervical canal and ultrasound to confirm oligohydraminos.

Subclinical infection will be detected with laboratory indices (WBC count of =15, 000 c/mm3, CRP of =1 mg/dL) without any clinical symptoms and signs of infection as urinary tract infection in group 1 patients.

Women with multiple pregnancies. Clinical signs of infection as (fever,abdominal tendernes). Cervical dilatations of 2 cm or more. Maternal disease like diabetes or fetal complications like intra-uterine fetal death.

Inclusion Criteria:

Exclusion Criteria:

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asymptomatic Infections
• Communicable Diseases
• Fetal Membranes, Premature Rupture
• Infection
• Intra-amniotic Subclinical Infection.

Intervention

Drug:
• procalcitonin
In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Oludag T, Gode F, Caglayan E, Saatli B, Okyay RE, Altunyurt S. Value of maternal procalcitonin levels for predicting subclinical intra-amniotic infection in preterm premature rupture of membranes. J Obstet Gynaecol Res. 2014 Apr;40(4):954-60. doi: 10.1111 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.	Procalcitonin.; C-reactive protein.; White blood cells count (total and diffrantiated).; C-reactive protein in neonates of groub 2.	one year	Yes
Primary	The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates.	The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates	one year	Yes
Secondary	Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.	Procalcitonin.; C-reactive protein.; White blood cells count (total and diffrantiated).; C-reactive protein in neonates of groub 2.	one year	Yes