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This is an observational study in which data from the participants who will be taking different vitamin supplementation regimes before and during pregnancy.
Vitamin deficiency is a condition where there is not enough vitamins in the body. During pregnancy, a woman's body may require more vitamins than usual. When the body does not get enough vitamins, people can take vitamin supplements to help increase the amount of vitamins in the body.
It is already known, that polyvitamins can decrease risks of anemia (low level of red cells in the blood), neural tube defects (severe congenital anomaly of neural system) or other malformations, but also on several pregnancy complications.
Nevertheless, a significant amount of evidence on the use of vitamins during pregnancy has been obtained in countries with low and middle level of living standards.
Countries with higher living standards may have different prevalence of vitamin insufficiency, thereby it is not clearly known how vitamin supplementation may help to reduce pregnancy complications in these population. So, researchers think it is important to do more studies.
Elevit contains many different vitamins and minerals. These vitamins and minerals are important to help women before and during pregnancy.
In this study, the researchers want to collect more data about how well pregnancies progress and the outcomes of the pregnancies in women who are taking different vitamin treatment or supplements, including elevit.
To do this, the researchers will review information collected from the participants to:
The participants will have decided with their doctor to start their vitamin treatment or supplements before getting pregnant or during their pregnancy.
During the study, the researchers will collect the women's information from their medical records taken during their regular medical appointments. The study will include women who are pregnant and who are planning to get pregnant. The study will include both women who have vitamin deficiency and women who do not have vitamin deficiency.
Each participant will be in this study for up to 18 months., The whole study will last about 2 years and 10 months. During this time, the participants will visit their doctor 5 times as part of their usual care. The study is planned to collect data from October 2021 until June 2024.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multivitamins usage in pregravidal preparation | Participants start use of Elevit multiple micronutrient (MMN) before pregnancy. |
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| Multivitamins usage during pregnancy | Participants start use of Elevit multiple micronutrient (MMN) in the first trimester of pregnancy. |
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| Folic acid usage during pregnancy | Participants use folic acid in accordance with clinical guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivitamins (Elevit, BAY987808) | Dietary Supplement | Following the manner of observational study, no intervention will be provided in the study. Participants follows approved clinical guidelines, without interference by the study initiator or study protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with normally completed pregnancies | Normally completed pregnancy is defined as pregnancies completed in term 37-42 weeks inclusive, with no major pregnancy maternal and fetus complications such as severe maternal anemia, preeclampsia, congenital anomalies, fetal growth retardation or other pregnancy complication concerned by the study investigator. | Up to 18 months |
| Number of participants with maternal anemia of any severity in third trimester (hemoglobin [Hb] <110 g/L) | Up to 18 months | |
| Number of participants with preeclampsia of any severity | Preeclampsia is defined (arterial hypertension blood pressure [BP]>= 140/90 mmHg) in combination with proteinuria (≥0.3 g/l in daily urine) after the 20th week of pregnancy); OR in absence of proteinuria with new onset of the following: Signs of multiple organ failure; Thrombocytopenia: platelet count less than 100,000 x 10^9 /L; Serum creatinine > 1.1 mg/dL or doubling of the serum creatinine; Elevated liver transaminases to twice normal; Pulmonary edema; New onset headache unresponsive to medication; Visual symptoms. | Up to 18 months |
| Number of participants with small-for-gestational newborns | Small for gestational age is defined as a newborn with weigh less than 10th percentile of normal weigh for gestational age. | Up to 18 months |
| Number of participants having low and very low birth weight newborns | Low birth weight is a term used to describe babies who are born weighing less than 5 pounds, 8 ounces (2,500 grams). Babies weighing less than 3 pounds, 5 ounces (1,500 grams) at birth are considered as very low birth weight. | Up to 18 months |
| Mean and change in score of quality of life gravidarum (QoL-Grav) in first to third trimester |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of anemia at any trimesters | Up to 18 months | |
| Number of usage of iron medications for the purposes of anemia | Up to 12 months | |
| Change of anemia severity from first to third trimester |
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Inclusion Criteria:
Exclusion Criteria:
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Women aged 18 through 45 (inclusive) planning a pregnancy or with an already confirmed pregnancy (pregnancy was confirmed using laboratory and/or instrumental methods, pregnancy term is up to 12 weeks), of different risk of having micronutrient insufficiency and using Elevit Multiple Micronutrient (MMN) or a monocomponent supplementation with folic acid and being in compliance with the inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Gennady T. Sukhikh, Dr. Medical Science, Professor | Federal State Budgetary Institution "National Medical Research Center for Obstetrics, Gynecology and Perinatology named after Academician V.I. Kulakov" Ministry of Health of the Russian Federation. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Kazakhstan | ||||
| Many Locations |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| Multivitamins (Elevit, BAY2906300) | Dietary Supplement | Following the manner of observational study, no intervention will be provided in the study. Participants follows approved clinical guidelines, without interference by the study initiator or study protocol. |
|
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| Multivitamins (Elevit, BAY987386) | Drug | Following the manner of observational study, no intervention will be provided in the study. Participants follows approved clinical guidelines, without interference by the study initiator or study protocol. |
|
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| Folic acid | Dietary Supplement | Following the manner of observational study, no intervention will be provided in the study. Participants follows approved clinical guidelines, without interference by the study initiator or study protocol. |
|
QoL-Grav questionnaire is designed for assessing the quality of life during pregravidal preparation and during pregnancy. The overall score normally varies from 15 to 35, the lower the score, the higher the quality of life. |
| Up to 12 months |
| Up to 12 months |
| Number of participants with preterm birth | Preterm birth is defined as a childbirth that occurred at a period of 22 to 37 complete weeks and with a fetal weight of more than 500g. Extremely preterm birth: 28 complete weeks; Early preterm birth: 28 to 32 weeks; Moderate to late preterm: 32 to 37 weeks. | Up to 12 months |
| Number of participants with fetal growth restriction during third trimester | Fetal growth restriction (FGR) is a condition in which an unborn baby (fetus) is smaller than expected for the number of weeks of pregnancy (gestational age). It is described as an estimated weight less than the 10th percentile. FGR will be assessed by ultrasonography specialist during usual ultrasound examination in 3rd trimester. | Up to 12 months |
| Number of participants with post-term birth | Post-term pregnancy is defined as pregnancy that has extended to or beyond 42 weeks of gestation (294 days). | Up to 12 months |
| Number of participants with gestational diabetes | Up to 12 months |
| Number of participants with confirmed glucose intolerance during third trimester | Up to 12 months |
| Number of participants with congenital malformations | Congenital malformations will be defined as any anomalies in the development of the fetus, classified as malformations and coded in ICD-10 as "Congenital anomalies [malformations], deformities and chromosomal disorders (Q00-Q99)". | Up to 12 months |
| Number of participants with fetal macrosomia | Large fetus defined as birth weight > 4000 g, provided that it is not caused by various congenital neoplasms and other fetal diseases (erythroblastosis, teratoma, hydrocephalus, etc.). | Up to 12 months |
| Number of participants with excessive vomiting in pregnant women | Vomiting occur in every third pregnancy, in 90% cases it is normal course of pregnancy and happens no more than 2-3 times a day, more often on an empty stomach, and does not violate the general condition of pregnant woman. | Up to 12 months |
| Number of pregnancy within 6 months of periconceptional supplementation in women with different levels of fertile function | In age groups up to 35 years and 35 years and older, with the presence of concomitant gynecological pathology (menstrual irregularities, inflammatory processes in the pelvic area, anomalies in development of genital organs, history of uterine surgery, endometriosis, obesity, hyper- and hypothyroidism, autoimmune diseases) | Up to 18 months |
| Number of participants with spontaneous abortion/miscarriage | Spontaneous miscarriage is the loss of pregnancy naturally before twenty weeks of gestation. | Up to 12 months |
| Normal weight gain in newborns in the first month of life in accordance with WHO child growth standards | WHO stands for world health organization. | Up to 12 months |
| Number of participants with exclusive breastfeeding, mixed and artificial feeding in the first month after delivery | Up to 12 months |
| Multiple Locations |
| Russia |
| Many Locations | Multiple Locations | Uzbekistan |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| ID | Term |
|---|---|
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C067316 | Geritol |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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