ParturitionNCT02363036
The Shift From Monocytes to Neutrophils in Blood Samples of Women in Labor
An observational study of Parturition, run by Hillel Yaffe Medical Center.
Trial summary
Accumulating evidence suggest that the proliferative, invasive, and immune tolerance mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the host immune response are similar to those used by the developing placenta during normal pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parturition
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Healthy women without any complications in the current pregnancy.
Who may be able to join
- Women in active labor normal pregnancy at term.
- Women, normal pregnancy at term who came for elective Cesarean Section without signs of labor (pain/contractions, etc).
Who cannot join
- Signs for infection ( fever >38 celsius degrees)
- Women in pre-term birth under 37 weeks.
- Any complication to the women or fetus which require induction of labor ( Pre-eclampsia, Gestational Diabetes Mellitus A2, Pre-gestational diabetes, Intrauterine Growth Restriction).
Trial locations and contacts
No sites are listed yet.
About this study
Accumulating evidence suggest that the proliferative, invasive, and immune tolerance mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the host immune response are similar to those used by the developing placenta during normal pregnancy. In addition to the shared capacity for invading through normal tissues, both cancer cells and cells of the developing placenta create a microenvironment supportive of both immunologic privilege and angiogenesis.
CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that consist of immature myeloid cells (IMCs), and were first described as myeloid-derived suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells have been shown to play an essential role in mediating immune suppression in animal models of human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been found in peripheral blood, lymphoid organs and the tumor tissue itself. An increased population of IMCs was identified in patients with several tumor types. Accordingly, IMCs detected in the peripheral blood of such patients bearing express the common myeloid marker CD33 but lack markers of mature myeloid cells such as the MHC class II molecule HLADR.
Read more
IMCs have been shown to actively promote tumor growth and metastasis by modulating the cytokine environment, and through vascular remodeling by promoting angiogenesis.
It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice and actively promote angiogenesis. These cells show striking similarity to IMCs that populate malignant tumors. Accordingly, human placentas are also infiltrated by a significant population of IMCs. Immunostaining of human placentas showed that IMCs comprise around 25% ( range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells and that this population is located close to blood capillaries. We also demonstrated that immature DCs, cells originally described to regulate the adaptive immune response, also promote angiogenesis in models of choroidal neovascularization, endometriosis and tumors.
This is a retrospective study on patient's blood samples of pregnant women who came to delivery in our department during 1.1.2014-31.12.2014, to compare the abundance of monocytes and neutrophils in: 1. Term active labor. 2. Elective cesarean section.
According to our previous findings, we hypothesize that monocytes in active delivery will be lower than in women without signs for labor. We also hypothesize that neutrophils will be more abundant in active delivery than in women without signs for labor.
We plan to screen anonymous electronic data of women who delivered in our departement during 2014 according to the following eligible criteria, stratified into 2 categories: 1. Women who were admitted in active labor. 2. Women who were admitted for elective Cesarean Section without signs of labor.
We will compare the abundance of monocytes and neutrophils in blood counts that were taken on admission day between the two populations.
- Conditions
- Parturition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active labor | Women in active labor normal pregnancy at term. | |
| Planned Cesarian Section | Women, normal pregnancy at term who came for elective Cesarean Section without signs of labor (pain/contractions, etc). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery
From admission time to delivery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturitionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363036
- Sponsor's protocol ID
- 0004-15-HYMC
- Status last verified
- Jan 2015
- First submitted
- 9 Feb 2015
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Shift From Monocytes to Neutrophils in Blood Samples of Women in Labor
- ClinicalTrials.gov ID
- NCT02363036
- Acronym / sponsor ID
- 0004-15-HYMC
- Conditions
- Parturition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accumulating evidence suggest that the proliferative, invasive, and immune tolerance mechanisms that malignant tumors use to establish a nutrient supply and evade or edit the host immune response are similar to those used by the developing placenta during normal pregnancy. In addition to the shared capacity for invading through normal tissues, both cancer cells and cells of the developing placenta create a microenvironment supportive of both immunologic privilege and angiogenesis.
CD11b+Gr1+ cells are a heterogeneous population of bone marrow-derived cells (BMDC) that consist of immature myeloid cells (IMCs), and were first described as myeloid-derived suppressor cells. In healthy individuals, IMCs that are generated in the bone marrow differentiate into mature granulocytes, macrophages, or dendritic cells (DCs). These cells have been shown to play an essential role in mediating immune suppression in animal models of human tumors. As a result of tumor-induced alterations in myelopoiesis, IMCs have been found in peripheral blood, lymphoid organs and the tumor tissue itself. An increased population of IMCs was identified in patients with several tumor types. Accordingly, IMCs detected in the peripheral blood of such patients bearing express the common myeloid marker CD33 but lack markers of mature myeloid cells such as the MHC class II molecule HLADR.
IMCs have been shown to actively promote tumor growth and metastasis by modulating the cytokine environment, and through vascular remodeling by promoting angiogenesis.
It has been demonstrated in our laboratory that IMCs infiltrate placentas of pregnant mice and actively promote angiogenesis. These cells show striking similarity to IMCs that populate malignant tumors. Accordingly, human placentas are also infiltrated by a significant population of IMCs. Immunostaining of human placentas showed that IMCs comprise around 25% ( range 10-40%) of total placental CD45+ bone marrow-derived hematopoietic cells and that this population is located close to blood capillaries. We also demonstrated that immature DCs, cells originally described to regulate the adaptive immune response, also promote angiogenesis in models of choroidal neovascularization, endometriosis and tumors.
This is a retrospective study on patient's blood samples of pregnant women who came to delivery in our department during 1.1.2014-31.12.2014, to compare the abundance of monocytes and neutrophils in: 1. Term active labor. 2. Elective cesarean section.
According to our previous findings, we hypothesize that monocytes in active delivery will be lower than in women without signs for labor. We also hypothesize that neutrophils will be more abundant in active delivery than in women without signs for labor.
We plan to screen anonymous electronic data of women who delivered in our departement during 2014 according to the following eligible criteria, stratified into 2 categories: 1. Women who were admitted in active labor. 2. Women who were admitted for elective Cesarean Section without signs of labor.
We will compare the abundance of monocytes and neutrophils in blood counts that were taken on admission day between the two populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active labor | – | –Women in active labor normal pregnancy at term. |
| Planned Cesarian Section | – | –Women, normal pregnancy at term who came for elective Cesarean Section without signs of labor (pain/contractions, etc). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy women without any complications in the current pregnancy.
Key inclusion criteria (2 listed)
- Women in active labor normal pregnancy at term.
- Women, normal pregnancy at term who came for elective Cesarean Section without signs of labor (pain/contractions, etc).
Key exclusion criteria (3 listed)
- Signs for infection ( fever >38 celsius degrees)
- Women in pre-term birth under 37 weeks.
- Any complication to the women or fetus which require induction of labor ( Pre-eclampsia, Gestational Diabetes Mellitus A2, Pre-gestational diabetes, Intrauterine Growth Restriction).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delivery
Time frame: 24 hours
From admission time to delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Parturition, run by Hillel Yaffe Medical Center.
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 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rivka Frankel, MD (052-8721581, rivka.lutvack@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2015.