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

NCT02284867 | Completed Results

• 2 other identifiers: NK Cells & Pretem laborpreterm labor pathogenesis
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Preterm Labour

Keywords

uterine natural killer cells; CD16; CD56; Preterm labour

Outcome Measures

Primary Outcomes (1)

• Uterine Natural Killer Cells In Preterm Labor

  Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample

  2 years

Secondary Outcomes (1)

• Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups

  2 years

Study Arms (2)

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

Term labor

Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .

Other: immunohistochemistry study

Interventions

immunohistochemistry study OTHER

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.

Preterm labor; Term labor

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The patients will be recruited from women attending casualty at Ain Shams University Maternity Hospital.

You may qualify if:

• Maternal age: 18-35 years old (to decrease the incidence of preterm labor related to age factor).
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (2)

• Koga K, Cardenas I, Aldo P, Abrahams VM, Peng B, Fill S, Romero R, Mor G. Activation of TLR3 in the trophoblast is associated with preterm delivery. Am J Reprod Immunol. 2009 Mar;61(3):196-212. doi: 10.1111/j.1600-0897.2008.00682.x.

  PMID: 19239422 BACKGROUND

• Murphy SP, Hanna NN, Fast LD, Shaw SK, Berg G, Padbury JF, Romero R, Sharma S. Evidence for participation of uterine natural killer cells in the mechanisms responsible for spontaneous preterm labor and delivery. Am J Obstet Gynecol. 2009 Mar;200(3):308.e1-9. doi: 10.1016/j.ajog.2008.10.043. Epub 2008 Dec 27.

  PMID: 19114277 BACKGROUND

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.

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Ahmed Mohammed Abass , Ass.lecturer in faculty of medicine
• Organization: Ain Shams university (AinShamsU)

ahmedmams@hotmail.com

002-01066903903

Study Officials

• Murad Elsaed, proffesor

  +02-01223165820

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: November 2, 2014
• First Posted: November 6, 2014
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 4, 2016
• Results First Posted: February 4, 2016

Record last verified: 2016-01