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

A

Ain Shams Maternity Hospital

Status

Unknown

Conditions

Intra-amniotic Subclinical Infection.

Treatments

Drug: procalcitonin

Study type

Observational

Funder types

Other

Identifiers

NCT02104791
MRCOG-1988

Details and patient eligibility

About

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

Full 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

Enrollment

100 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

100 participants in 3 patient groups

procalcitonin in blood
Description:
-Group 1: Healthy preterm Group: will include 50 pregnant females all at 24-34 weeks of gestational age .
Treatment:
Drug: procalcitonin
plasma of blood
Description:
-Group 2: Preterm premature rupture of membrane Group include 50 pregnant women
Treatment:
Drug: procalcitonin
procalcitonin,prematureruptureofmembrane in blood
Description:
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.
Treatment:
Drug: procalcitonin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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