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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02284867
Enrollment
60
Registered
2014-11-06
Start date
2012-08-31
Completion date
2014-12-31
Last updated
2016-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Labour

Keywords

uterine natural killer cells, CD16, CD56, Preterm labour

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 .

Detailed 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.

Interventions

OTHERimmunohistochemistry 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.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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 .

Design outcomes

Primary

MeasureTime frameDescription
Uterine Natural Killer Cells In Preterm Labor2 yearsNumber of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample

Secondary

MeasureTime frameDescription
Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups2 yearsCD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.

Participant flow

Recruitment details

Our study was conducted at Ain Shams University Maternity Hospital during the period between August 2012 and December 2014. A total of 60 pregnant women were included in the study.

Pre-assignment details

Adequate placental tissue sampled and proper primary storage technique then proper way of staining

Participants by arm

ArmCount
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 . 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.
30
Term Labor
Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy . 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.
30
Total60

Baseline characteristics

CharacteristicPreterm LaborTerm LaborTotal
Age, Continuous25.8 years
STANDARD_DEVIATION 4
26.4 years
STANDARD_DEVIATION 3.9
26.1 years
STANDARD_DEVIATION 4
Body Mass Index21.7 Kg/M^2
STANDARD_DEVIATION 2.3
21.8 Kg/M^2
STANDARD_DEVIATION 2.3
21.7 Kg/M^2
STANDARD_DEVIATION 2.4
Parity1 live birth2 live birth1 live birth
Sex: Female, Male
Female
30 Participants30 Participants60 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

Uterine Natural Killer Cells In Preterm Labor

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

Time frame: 2 years

ArmMeasureGroupValue (NUMBER)
Preterm LaborUterine Natural Killer Cells In Preterm LaborCD16+ uterine Natural Killer Cells21 participants
Preterm LaborUterine Natural Killer Cells In Preterm LaborCD56 bright uterine Natural Killer cells0 participants
Term LaborUterine Natural Killer Cells In Preterm LaborCD16+ uterine Natural Killer Cells1 participants
Term LaborUterine Natural Killer Cells In Preterm LaborCD56 bright uterine Natural Killer cells0 participants
Comparison: Categorical data were presented as number and percentage and differences were compared using the Pearson chi-squared test. Ordinal data were compared using the chi-squared test for trend~A two-sided p-value \<0.05 was considered statistically significant.p-value: <0.000295% CI: [6.96, 606.76]Regression, Logistic
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.

Time frame: 2 years

ArmMeasureGroupValue (NUMBER)
Preterm LaborComparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study GroupsPositive CD16+ CD56 dim villous only NK cells1 participants
Preterm LaborComparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study GroupsPositive CD16+ CD56dim villos and decidua NK cells0 participants
Term LaborComparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study GroupsPositive CD16+ CD56 dim villous only NK cells10 participants
Term LaborComparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study GroupsPositive CD16+ CD56dim villos and decidua NK cells11 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026