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Are Uterine Natural Killer Cells Involved in the Initiation of Preterm Labor ?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284867
First Posted: November 6, 2014
Last Update Posted: February 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ahmed Abass, Ain Shams University
  Purpose

Research question:

Population of study: women diagnosed as term pregnancy in labor (control) and the other group diagnosed as preterm labor (cases).

Intervention: measuring uterine natural killer cells . Outcome: uterine natural killer cells has a role in initiation of preterm labor.

Research hypothesis:

• Are uterine Natural Killer cells involved in the initiation of preterm labor ?

Medical Application:

• Possibility of prediction of preterm labor by assessment of Natural killer cells as well as preventing preterm labor by suppressing their activity .


Condition Intervention
Preterm Labour Other: immunohistochemistry study

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 4 Weeks
Official Title: Comparison Between Uterine Natural Killer Cells In Preterm Labor And Term Labor

Further study details as provided by Ahmed Abass, Ain Shams University:

Primary Outcome Measures:
  • Uterine Natural Killer Cells In Preterm Labor [ Time Frame: 2 years ]
    Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample


Secondary Outcome Measures:
  • Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups [ Time Frame: 2 years ]
    CD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.


Biospecimen Retention:   Samples With DNA
a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . Immunohisto-chemistery study will be done at Ain Shams Maternity Hospital Histopathology department.

Enrollment: 60
Study Start Date: August 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Preterm labor
Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .
Other: immunohistochemistry study
After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department.
Term labor
Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .
Other: immunohistochemistry study
After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients will be recruited from women attending casualty at Ain Shams University Maternity Hospital.
Criteria

Inclusion Criteria:

  1. Maternal age: 18-35 years old (to decrease the incidence of preterm labor related to age factor).
  2. Women who present with viable pregnancy (between 28 and 37 weeks' gestation), and having a threatened preterm labor (which is defined as ≥ 2 uterine contractions at 28-37 weeks' gestation, The onset of labor may be determined by documented uterine contractions (at least one every 10 minutes) and ruptured fetal membranes or documented cervical change with an estimated length of less than 1cm or cervical dilation of more than 2 cm. Threatened preterm labor may be diagnosed when there are documented uterine contractions but no evidence of cervical change.

Exclusion Criteria:

  1. Multiple pregnancy.
  2. Documented uterine anomalies.
  3. Oligohydramnios and polyhydramnios .
  4. Medical disorders as Diabetes mellitus and hypertension.
  5. Preterm premature rupture of membranes.
  6. Conditions that may have an influence on immune reaction e.g. history of chorioamnionitis.
  7. Smoking as a risk factor for preterm labor.
  8. Patients having Autoimmune disorder as it may affect Uterine NK( natural killer ) cells level .
  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): NCT02284867


Sponsors and Collaborators
Ain Shams University
Investigators
Study Chair: Murad Elsaed, proffesor +02-01223165820
  More Information

Publications:
Responsible Party: Ahmed Abass, Assistant lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT02284867     History of Changes
Other Study ID Numbers: NK Cells & Pretem labor
preterm labor pathogenesis ( Other Identifier: AinShamsU )
First Submitted: November 2, 2014
First Posted: November 6, 2014
Results First Submitted: December 23, 2014
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016
Last Verified: January 2016

Keywords provided by Ahmed Abass, Ain Shams University:
uterine natural killer cells
CD16
CD56
Preterm labour

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications