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

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ClinicalTrials.gov Identifier: NCT02104791

Recruitment Status : Unknown

Verified April 2014 by Alaa Sayed Hassanin, Ain Shams Maternity Hospital.
Recruitment status was: Enrolling by invitation

First Posted : April 4, 2014

Last Update Posted : April 4, 2014

Sponsor:

Information provided by (Responsible Party):

Alaa Sayed Hassanin, Ain Shams Maternity Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Intra-amniotic Subclinical Infection.	Drug: procalcitonin

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 Design

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Study Type :	Observational
Actual Enrollment :	100 participants
Observational Model:	Case Control
Time Perspective:	Retrospective
Official Title:	Procalcitonin Has a Role to Play in Prediction of Intra-amniotic Subclinical Infection.
Study Start Date :	May 2014
Estimated Primary Completion Date :	May 2015

Groups and Cohorts

Group/Cohort	Intervention/treatment
procalcitonin in blood -Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .	Drug: procalcitonin In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection? Other Name: plasma
plasma of blood -Group 2: Preterm premature rupture of membrane Group include 50 pregnant women	Drug: procalcitonin In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection? Other Name: plasma
procalcitonin,prematureruptureofmembrane in blood 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.	Drug: procalcitonin In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection? Other Name: plasma

Outcome Measures

Primary Outcome Measures :

The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates. [ Time Frame: one year ]
The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates

Secondary Outcome Measures :

Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2. [ Time Frame: one year ]
Procalcitonin.
- C-reactive protein.
- White blood cells count (total and diffrantiated).
- C-reactive protein in neonates of groub 2.

Other Outcome Measures:

Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2. [ Time Frame: one year ]
Procalcitonin.
- C-reactive protein.
- White blood cells count (total and diffrantiated).
- C-reactive protein in neonates of groub 2.

Biospecimen Retention: Samples Without DNA

plasma

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

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.

Criteria

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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104791

Locations

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Egypt
Ain Shams Maternity Hospital
Cairo, Egypt, 02

Sponsors and Collaborators

Ain Shams Maternity Hospital

More Information

Publications of Results:

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/jog.12273. Epub 2013 Dec 10.

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Responsible Party:	Alaa Sayed Hassanin, Lecturer, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:	NCT02104791 History of Changes
Other Study ID Numbers:	MRCOG-1988
First Posted:	April 4, 2014 Key Record Dates
Last Update Posted:	April 4, 2014
Last Verified:	April 2014

Keywords provided by Alaa Sayed Hassanin, Ain Shams Maternity Hospital:


Procalcitonin intra-amniotic subclinical infection.

Additional relevant MeSH terms:

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Infection Communicable Diseases Asymptomatic Infections	Asymptomatic Diseases Disease Attributes Pathologic Processes

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