Preterm LabourNCT02284867
Are Uterine Natural Killer Cells Involved in the Initiation of Preterm Labor ?
An observational study of Preterm Labour, run by Ain Shams University.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Preterm Labour
- What is being tested?
- immunohistochemistry study
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2014
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: The patients will be recruited from women attending casualty at Ain Shams University Maternity Hospital.
Who may be able to join
- 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.
Who cannot join
- 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 .
About this study
Official title: Comparison Between Uterine Natural Killer Cells In Preterm Labor And Term Labor
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 .
Read the 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.
- Conditions
- Preterm Labour
- Being tested
- immunohistochemistry study
- Keywords
- uterine natural killer cells, CD16, CD56, Preterm labour
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemistry studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Other: immunohistochemistry study | |
| Term labor | Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy . Receives: Other: immunohistochemistry study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine Natural Killer Cells In Preterm Labor
Number of participants with CD16 orCD 56 uterine Natural Killer Cells positive staining of placental sample
Measured: 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
CD16+ CD56dim uterine Natural Killer cells (uNK) in the villi was found in Preterm delivery Group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm LabourStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abass, Ain Shams University
- Investigators
- Murad Elsaed, proffesor, Study chair, +02-01223165820
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284867
- Sponsor's protocol ID
- NK Cells & Pretem labor
- Other IDs
- preterm labor pathogenesis
- Status last verified
- Jan 2016
- First submitted
- 2 Nov 2014
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19239422Murphy 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.
PubMed 19114277
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Uterine Natural Killer Cells In Preterm Labor And Term Labor
- ClinicalTrials.gov ID
- NCT02284867
- Acronym / sponsor ID
- NK Cells & Pretem labor
- Conditions
- Preterm Labour
- Keywords
- uterine natural killer cells, CD16, CD56, Preterm labour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Posted 4 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm labor | – | Other: immunohistochemistry studyPatients 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 . |
| Term labor | – | Other: immunohistochemistry studyPatient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy . |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patients will be recruited from women attending casualty at Ain Shams University Maternity Hospital.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- Multiple pregnancy.
- Documented uterine anomalies.
- Oligohydramnios and polyhydramnios .
- Medical disorders as Diabetes mellitus and hypertension.
- Preterm premature rupture of membranes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemistry studyAfter 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. | Other | Preterm labor, Term labor |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19239422Koga 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.
- Background: PubMed 19114277Murphy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murad Elsaed, proffesor study chair
+02-01223165820
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Labour, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine Natural Killer Cells In Preterm Labor (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284867, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.