Clinical trial NCT02104791: Evaluation of the Role of Plasma Procalcitonin in Prediction of Intra-amniotic Infection in Preterm Premature Rupture of Membrane
Official title: Procalcitonin Has a Role to Play in Prediction of Intra-amniotic Subclinical Infection.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intra-amniotic Subclinical Infection.
Keywords: Procalcitonin
intra-amniotic subclinical infection.
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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

Eligibility 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:

-

Primary outcomes:
measure: The correlation between procalcitonin level in PPROM and C-reactive protein level in neonates.
timeFrame: one year
Secondary outcomes:
measure: Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.
timeFrame: one year
Other outcomes:
measure: Procalcitonin. - C-reactive protein. - White blood cells count (total and diffrantiated). -C-reactive protein in neonates of groub 2.
timeFrame: one year
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Maternity Hospital
Study officials:
References:
citation: 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.