Correlation of Cytokines and Anthropometry in PregnancyNCT03761966
Cytokines Profile at the Beginning of Pregnancy
An observational study of Correlation of Cytokines and Anthropometry in Pregnancy, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.
Trial summary
A mechanism by which obesity could influence the increase in obstetric complications as more weight is gained, apart from oxidative stress (3) would be the changes in the expression profile of T helper (Th) cells. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Correlation of Cytokines and Anthropometry in Pregnancy
- What is being tested?
- Pregnant women
- How many people
- 83 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2017to Dec 2017
- How long will I take part?
- 1 Year
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women older than 18 years old attender at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital, located in Toluca City. For a population of 8500 pregnant women annually attended, and a margin of error of 11%, the sample should be of 79 people.
Who may be able to join
- Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent.
Who cannot join
- Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytokines Profile at the Beginning of Pregnancy in Mexican Women
A mechanism by which obesity could influence the increase in obstetric complications as more weight is gained, apart from oxidative stress (3) would be the changes in the expression profile of T helper (Th) cells. Due to the increase rate of obesity among Mexican women, the aim was to determine if there is some association between the weight changes in pregnancy and the cytokines Interleukin (IL)-10, IL-4, Interferon gamma (IFN-γ) and Tumor Necrosis Factor alpha (TNF-α).
Read the detailed description
Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent. Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.
Weight and height were measured using a calibrated using an adult scale (Seca, Hamburg, Germany). Blood Pressure (BP; mmHg) was checked by auscultation using a standard sphygmomanometer (Riester Big Ben® Square; Jangingen, Germany). All mothers received written nutritional guidance depending on the characteristics of each patient.
The expression levels of IL-10, IL-4, IFN-γ and TNF-α was performed by the ELISA technique.
Quantitative variables will be represented by measures of central tendency. Once the Kolmogorov test is performed for the normality of the variables, either the Student's T test or the Mann Whitney U test will be used to compare both groups. With the same criteria for normality either Pearson or Spearmen correlation will be used among the cytokines and anthropometric variables, considering a significant difference at p ≤ 0.05. The statistical analysis will be carried out in the Statistical Package for the Social Sciences (SPSS) program, version 19.
- Being tested
- Pregnant women
- Keywords
- IL-10, IL-4, IFN-γ, TNF-α, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant womenOther
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women | Pregnant women older than 18 years old atended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM). Receives: Other: Pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokines levels
The expression levels of IL-10, IL-4, IFN-γ and TNF-α will be performed by the ELISA technique on an ELx800 ™ device (BioTek Instruments, Inc.) at the Research Laboratory of Ciprés Grupo Médico S.C. (CGM).
Measured: 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study startJan 2017
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Correlation of Cytokines and Anthropometry in PregnancyStudies 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
- 83 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Materno-Perinatal Hospital of the State of Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico, Ciprés Grupo Médico CGM SC
- Responsible party
- Principal investigator, Hugo Mendieta Zeron, Materno-Perinatal Hospital of the State of Mexico
- Investigators
- Hugo Mendieta Zerón, PhD, Principal investigator, Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761966
- Sponsor's protocol ID
- 217B500402015066
- Status last verified
- Nov 2018
- First submitted
- 30 Nov 2018
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The final data will be available upon request if requiered by the selected journal to publish the final manuscript.
Publications
Lombardelli L, Aguerre-Girr M, Logiodice F, Kullolli O, Casart Y, Polgar B, Berrebi A, Romagnani S, Maggi E, Le Bouteiller P, Piccinni MP. HLA-G5 induces IL-4 secretion critical for successful pregnancy through differential expression of ILT2 receptor on decidual CD4(+) T cells and macrophages. J Immunol. 2013 Oct 1;191(7):3651-62. doi: 10.4049/jimmunol.1300567. Epub 2013 Aug 30.
PubMed 23997222Cheng SB, Sharma S. Interleukin-10: a pleiotropic regulator in pregnancy. Am J Reprod Immunol. 2015 Jun;73(6):487-500. doi: 10.1111/aji.12329. Epub 2014 Oct 1.
PubMed 25269386Ziganshina MM, Krechetova LV, Vanko LV, Nikolaeva MA, Khodzhaeva ZS, Sukhikh GT. Time course of the cytokine profiles during the early period of normal pregnancy and in patients with a history of habitual miscarriage. Bull Exp Biol Med. 2013 Jan;154(3):385-7. doi: 10.1007/s10517-013-1956-0.
PubMed 23484206Wegmann TG, Lin H, Guilbert L, Mosmann TR. Bidirectional cytokine interactions in the maternal-fetal relationship: is successful pregnancy a TH2 phenomenon? Immunol Today. 1993 Jul;14(7):353-6. doi: 10.1016/0167-5699(93)90235-D.
PubMed 8363725
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokines Profile at the Beginning of Pregnancy in Mexican Women
- ClinicalTrials.gov ID
- NCT03761966
- Acronym / sponsor ID
- 217B500402015066
- Keywords
- IL-10, IL-4, IFN-γ, TNF-α, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Materno-Perinatal Hospital of the State of MexicoUniversity, hospital or other
- Collaborators
- Universidad Autonoma del Estado de Mexico, Ciprés Grupo Médico CGM SC
- Study start
- Jan 2017 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 Dec 2018 (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.
A mechanism by which obesity could influence the increase in obstetric complications as more weight is gained, apart from oxidative stress (3) would be the changes in the expression profile of T helper (Th) cells. Due to the increase rate of obesity among Mexican women, the aim was to determine if there is some association between the weight changes in pregnancy and the cytokines Interleukin (IL)-10, IL-4, Interferon gamma (IFN-γ) and Tumor Necrosis Factor alpha (TNF-α).
Detailed description
Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent. Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.
Weight and height were measured using a calibrated using an adult scale (Seca, Hamburg, Germany). Blood Pressure (BP; mmHg) was checked by auscultation using a standard sphygmomanometer (Riester Big Ben® Square; Jangingen, Germany). All mothers received written nutritional guidance depending on the characteristics of each patient.
The expression levels of IL-10, IL-4, IFN-γ and TNF-α was performed by the ELISA technique.
Quantitative variables will be represented by measures of central tendency. Once the Kolmogorov test is performed for the normality of the variables, either the Student's T test or the Mann Whitney U test will be used to compare both groups. With the same criteria for normality either Pearson or Spearmen correlation will be used among the cytokines and anthropometric variables, considering a significant difference at p ≤ 0.05. The statistical analysis will be carried out in the Statistical Package for the Social Sciences (SPSS) program, version 19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | Other: Pregnant womenPregnant women older than 18 years old atended at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital (HMPMPS), Health Institute of the State of Mexico (ISEM). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women older than 18 years old attender at the "Mónica Pretelini Sáenz" Maternal-Perinatal Hospital, located in Toluca City. For a population of 8500 pregnant women annually attended, and a margin of error of 11%, the sample should be of 79 people.
Key inclusion criteria (1 listed)
- Pregnant women older than 18 years old were invited to participate and all were asked to sign the informed consent.
Key exclusion criteria (1 listed)
- Women with congenital heart disease, disabling diseases, infectious diseases and autoimmune diseases were excluded and those whose clinical follow-up was lost were discarded from the final analysis.
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 |
|---|---|---|
| Pregnant women | Other | Pregnant women |
Primary outcome
Cytokines levels
Time frame: 2017-2018
The expression levels of IL-10, IL-4, IFN-γ and TNF-α will be performed by the ELISA technique on an ELx800 ™ device (BioTek Instruments, Inc.) at the Research Laboratory of Ciprés Grupo Médico S.C. (CGM).
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 3 Dec 2018.
- Background: PubMed 23997222Lombardelli L, Aguerre-Girr M, Logiodice F, Kullolli O, Casart Y, Polgar B, Berrebi A, Romagnani S, Maggi E, Le Bouteiller P, Piccinni MP. HLA-G5 induces IL-4 secretion critical for successful pregnancy through differential expression of ILT2 receptor on decidual CD4(+) T cells and macrophages. J Immunol. 2013 Oct 1;191(7):3651-62. doi: 10.4049/jimmunol.1300567. Epub 2013 Aug 30.
- Background: PubMed 25269386Cheng SB, Sharma S. Interleukin-10: a pleiotropic regulator in pregnancy. Am J Reprod Immunol. 2015 Jun;73(6):487-500. doi: 10.1111/aji.12329. Epub 2014 Oct 1.
- Background: PubMed 23484206Ziganshina MM, Krechetova LV, Vanko LV, Nikolaeva MA, Khodzhaeva ZS, Sukhikh GT. Time course of the cytokine profiles during the early period of normal pregnancy and in patients with a history of habitual miscarriage. Bull Exp Biol Med. 2013 Jan;154(3):385-7. doi: 10.1007/s10517-013-1956-0.
- Background: PubMed 8363725Wegmann TG, Lin H, Guilbert L, Mosmann TR. Bidirectional cytokine interactions in the maternal-fetal relationship: is successful pregnancy a TH2 phenomenon? Immunol Today. 1993 Jul;14(7):353-6. doi: 10.1016/0167-5699(93)90235-D.
- Individual participant dataSharing planned: Undecided. The final data will be available upon request if requiered by the selected journal to publish the final manuscript.
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.
Hugo Mendieta Zerón, PhD principal investigator
Maternal-Perinatal Hospital "Mónica Pretelini Sáenz"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Correlation of Cytokines and Anthropometry in Pregnancy, run by Materno-Perinatal Hospital of the State of Mexico at 1 site in Mexico.
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 1 inclusion and 1 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 3 Dec 2018. 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 Mexico. 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?
Cytokines levels (time frame: 2017-2018). 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 NCT03761966, which also lists 4 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 3 Dec 2018.