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

Preterm Labour Clinical Trial

Official title:

Comparison Between Uterine Natural Killer Cells In Preterm Labor And Term Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284867
• Other study ID #: NK Cells & Pretem labor
• Secondary ID: preterm labor pa
• Status: Completed
• Phase: N/A
• First received: November 2, 2014
• Last updated: January 5, 2016
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

Description:

Type of the Study:

This is a case control study .

Study Settings:

This clinical trial will be conducted at Ain Shams University Maternity Hospital and the laboratory work will be done at Ain Shams University histopathology Laboratory , in the period between August 2012 to August 2014 .

Study Population:

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

The included patients will be

Divided into two groups:

• Group 1: 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 .

• Group 2: Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .

Intervention:

After taking informed written consent, the recruited patients will be subjected to the following:

• History taking, with particular emphasis on: Past medical history (no diabetes mellitus, no hypertension, etc..) Past obstetric history (history of preterm labor). Menstrual history(to be sure of her LMP( last menstrual period) and this date is reliable).

• Having earlier ultrasound to document gestational age.

• History of labor pains which is becoming regular and frequent.

• No suggestive history of preterm prelabor rupture of membranes

• General examination with particular emphasis on blood pressure, weight and height.

• Abdominal examination with particular emphasis on uterine activity.

• Obstetric ultrasound (transabdominal) to document viability of pregnancy and to ensure the gestational age.

• Included patients will receive tocolysis (according to Ain Shams University Maternity hospital protocol which is recommending usage of calcium channel blocker (Nifedipine) Initially 10mg orally every 15 minutes, up to 4 doses of Nifedipine to stop contractions. After this slow release nifedipine. It has been found that an 8 hourly dosage of 40mg - 20mg - 40mg calcium channel blocker is suitable for most women. This is in addition to use of steroids to enhance lung maturity (dexamethasone, 6 mg intramuscular /12 hrs for 48 hrs)

• Patients will be traced by fetal monitor and uterine tocodynamometer (Oxford Sonicaid Team ®)to monitor uterine contractions and if the treatment was successful or not.

• After delivery 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 .

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labour

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups	CD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.	2 years	Yes