Trial Outcomes & Findings for Are Uterine Natural Killer Cells Involved in the Initiation of Preterm Labor ? (NCT NCT02284867)
NCT ID: NCT02284867
Last Updated: 2016-02-04
Results Overview
Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample
Recruitment status
COMPLETED
Target enrollment
60 participants
Primary outcome timeframe
2 years
Results posted on
2016-02-04
Participant Flow
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.
Adequate placental tissue sampled and proper primary storage technique then proper way of staining
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Are Uterine Natural Killer Cells Involved in the Initiation of Preterm Labor ?
Baseline characteristics by cohort
| Measure |
Preterm Labor
n=30 Participants
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.
|
Term Labor
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 4 • n=5 Participants
|
26.4 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
26.1 years
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Parity
|
1 live birth
n=5 Participants
|
2 live birth
n=7 Participants
|
1 live birth
n=5 Participants
|
|
Body Mass Index
|
21.7 Kg/M^2
STANDARD_DEVIATION 2.3 • n=5 Participants
|
21.8 Kg/M^2
STANDARD_DEVIATION 2.3 • n=7 Participants
|
21.7 Kg/M^2
STANDARD_DEVIATION 2.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample
Outcome measures
| Measure |
Preterm Labor
n=30 Participants
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.
|
Term Labor
n=30 Participants
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.
|
|---|---|---|
|
Uterine Natural Killer Cells In Preterm Labor
CD16+ uterine Natural Killer Cells
|
21 participants
|
1 participants
|
|
Uterine Natural Killer Cells In Preterm Labor
CD56 bright uterine Natural Killer cells
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 yearsCD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.
Outcome measures
| Measure |
Preterm Labor
n=30 Participants
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.
|
Term Labor
n=30 Participants
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.
|
|---|---|---|
|
Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups
Positive CD16+ CD56 dim villous only NK cells
|
1 participants
|
10 participants
|
|
Comparison of CD16+ CD56 Dim Uterine Natural Killer Cells (uNK) Prevalence in Decidua vs. Villi in Placenta of Both Study Groups
Positive CD16+ CD56dim villos and decidua NK cells
|
0 participants
|
11 participants
|
Adverse Events
Preterm Labor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Term Labor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Ahmed Mohammed Abass , Ass.lecturer in faculty of medicine
Ain Shams university (AinShamsU)
Phone: 002-01066903903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place