Obstetric Labor, PrematureNCT03211338
Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone
A study testing Culture with progesterone, Culture without progesterone and Culture with growth factors in people with Obstetric Labor, Premature, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic cells (DC). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Labor, Premature
- What is being tested?
- Culture with progesterone, Culture without progesterone and Culture with growth factors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jul 2017to 6 Jun 2022
- Phase
- Interventional
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Placentas from term and preterm deliveries
- Singleton pregnancy
- Consent to participate
Who cannot join
- Pregnancies with obstetric complications
- Multiple gestation
- Maternal illness or fetal malformation known pre-delivery
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic cells (DC).
- Conditions
- Obstetric Labor, Premature
- Being tested
- Culture with progesterone, Culture without progesterone, Culture with growth factors
- 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.
Culture with progesteroneBiological
Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
Culture without progesteroneBiological
Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
Culture with growth factorsBiological
Culture of placental IMC cells with growth hormones only and analysis
| Study group | Role | What they receive |
|---|---|---|
| Preterm labor placentas and progesterone | Active comparator | IMC cells taken from preterm labor placentas after delivery will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture with progesterone |
| Term labor placentas and progesterone | Active comparator | IMC cells taken from term labor placentas after delivery will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture with progesterone |
| Preterm labor placentas without progesterone | Active comparator | IMC cells taken from preterm labor placentas after delivery will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture without progesterone |
| Term labor placentas without progesterone | Active comparator | IMC cells taken from term labor placentas after delivery will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture without progesterone |
| Term placentas from progesterone treated pregnancies | Active comparator | IMC cells taken from term labor placentas from women that were treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture with growth factors |
| Preterm placentas from progesterone treated pregnancies | Active comparator | IMC cells taken from preterm labor placentas from women that were treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture with growth factors |
| Term placentas not treated with progesterone in pregnancy | Active comparator | IMC cells taken from term placentas from women who were not treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture with growth factors |
| Preterm placentas not treated with progesterone in pregnancy | Active comparator | IMC cells taken from preterm placentas from women who were not treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture with growth factors |
| Term postpartum blood samples with progesterone | Active comparator | CD-14+ monocyte cells taken from women delivering at term will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture with progesterone |
| Preterm postpartum blood samples with progesterone | Active comparator | CD-14+ monocyte cells taken from women delivering preterm will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture with progesterone |
| Term postpartum blood samples without progesterone | Active comparator | CD-14+ monocyte cells taken from women delivering at term will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture without progesterone |
| Preterm postpartum blood samples without progesterone | Active comparator | CD-14+ monocyte cells taken from women delivering preterm will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. Receives: Biological: Culture without progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation characteristic effects of progesterone on preterm and term placentas
Differences observed in cytokine profiles of IMC cells from term and preterm placentas cultured with and without progesterone
Measured: One year
Maturation effects of progesterone on preterm and term placentas
Differences observed in maturation of IMC cells into DC cells in term and preterm placentas
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start15 Jul 2017
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor, PrematureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Rinat Gabbay-Benziv, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211338
- Sponsor's protocol ID
- HYMC-0061-17
- Status last verified
- Jun 2022
- First submitted
- 5 Jul 2017
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Cell Maturation in Preterm Delivery Placentas - in Vitro and in Vivo Effect of Progesterone
- ClinicalTrials.gov ID
- NCT03211338
- Acronym / sponsor ID
- HYMC-0061-17
- Conditions
- Obstetric Labor, Premature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 7 Jul 2017 (actual)
- 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.
The aim of this study is to investigate the In Vitro and In Vivo effect of progesterone on immature myeloid cells (IMC), inflammation characteristics and maturation into dendritic cells (DC).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Preterm labor placentas and progesterone | Active comparator | Biological: Culture with progesteroneIMC cells taken from preterm labor placentas after delivery will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. |
| Term labor placentas and progesterone | Active comparator | Biological: Culture with progesteroneIMC cells taken from term labor placentas after delivery will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. |
| Preterm labor placentas without progesterone | Active comparator | Biological: Culture without progesteroneIMC cells taken from preterm labor placentas after delivery will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. |
| Term labor placentas without progesterone | Active comparator | Biological: Culture without progesteroneIMC cells taken from term labor placentas after delivery will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. |
| Term placentas from progesterone treated pregnancies | Active comparator | Biological: Culture with growth factorsIMC cells taken from term labor placentas from women that were treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. |
| Preterm placentas from progesterone treated pregnancies | Active comparator | Biological: Culture with growth factorsIMC cells taken from preterm labor placentas from women that were treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. |
| Term placentas not treated with progesterone in pregnancy | Active comparator | Biological: Culture with growth factorsIMC cells taken from term placentas from women who were not treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. |
| Preterm placentas not treated with progesterone in pregnancy | Active comparator | Biological: Culture with growth factorsIMC cells taken from preterm placentas from women who were not treated with progesterone during pregnancy will be analyzed for inflammation characteristics and maturation into DC cells. |
| Term postpartum blood samples with progesterone | Active comparator | Biological: Culture with progesteroneCD-14+ monocyte cells taken from women delivering at term will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. |
| Preterm postpartum blood samples with progesterone | Active comparator | Biological: Culture with progesteroneCD-14+ monocyte cells taken from women delivering preterm will be cultured with progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. |
| Term postpartum blood samples without progesterone | Active comparator | Biological: Culture without progesteroneCD-14+ monocyte cells taken from women delivering at term will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. |
| Preterm postpartum blood samples without progesterone | Active comparator | Biological: Culture without progesteroneCD-14+ monocyte cells taken from women delivering preterm will be cultured without progesterone and will be analyzed for inflammation characteristics and maturation into DC cells. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Placentas from term and preterm deliveries
- Singleton pregnancy
- Consent to participate
Key exclusion criteria (3 listed)
- Pregnancies with obstetric complications
- Multiple gestation
- Maternal illness or fetal malformation known pre-delivery
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 |
|---|---|---|
| Culture with progesteroneProgesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells | Biological | Preterm labor placentas and progesterone, Preterm postpartum blood samples with progesterone, Term labor placentas and progesterone, Term postpartum blood samples with progesterone |
| Culture without progesteroneCulture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone | Biological | Preterm labor placentas without progesterone, Preterm postpartum blood samples without progesterone, Term labor placentas without progesterone, Term postpartum blood samples without progesterone |
| Culture with growth factorsCulture of placental IMC cells with growth hormones only and analysis | Biological | Preterm placentas from progesterone treated pregnancies, Preterm placentas not treated with progesterone in pregnancy, Term placentas from progesterone treated pregnancies, Term placentas not treated with progesterone in pregnancy |
Primary outcome
Inflammation characteristic effects of progesterone on preterm and term placentas
Time frame: One year
Differences observed in cytokine profiles of IMC cells from term and preterm placentas cultured with and without progesterone
Maturation effects of progesterone on preterm and term placentas
Time frame: One year
Differences observed in maturation of IMC cells into DC cells in term and preterm placentas
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Rinat Gabbay-Benziv, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culture with progesterone, Culture without progesterone and Culture with growth factors in people with Obstetric Labor, Premature, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 3 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: finished, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inflammation characteristic effects of progesterone on preterm and term placentas (time frame: One year). The study lists 2 primary outcomes in all. 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 23 Jun 2022.