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

NCT02104791 | Unknown DMC

• 1 other identifier: MRCOG-1988
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intra-amniotic Subclinical Infection.

Keywords

Procalcitonin; intra-amniotic subclinical infection.

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.

  one year

Other Outcomes (1)

• Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.

  one year

Study Arms (3)

procalcitonin in blood

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

Drug: procalcitonin

plasma of blood

-Group 2: Preterm premature rupture of membrane Group include 50 pregnant women

Drug: procalcitonin

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

Interventions

procalcitonin DRUG

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

Also known as: plasma

plasma of blood; procalcitonin in blood; procalcitonin,prematureruptureofmembrane in blood

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

Sponsors & Collaborators

• Ain Shams Maternity Hospital: lead

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, 02, Egypt

Location

Related 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/jog.12273. Epub 2013 Dec 10.

  PMID: 24320627 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Interventions

Procalcitonin

Intervention Hierarchy (Ancestors)

Calcitonin; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Protein Precursors; Proteins

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 4, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

EG (1)