A Study to Gather Information About the Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Plans Before and During Pregnancy
Study Details
Study Description
Brief Summary
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:
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calculate how many women give birth without any complications between weeks 37 and 42 of their pregnancies
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calculate how many women have low levels of red blood cells in the blood during the third trimester of their pregnancies
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calculate how many women have a serious condition called preeclampsia during their pregnancy, a condition in which pregnant women have a sudden rise in blood pressure and swelling in the hands, feet and face
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calculate how many women give birth to babies who weigh less than expected at the time of their birth
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give the women a questionnaire to complete during each trimester to see how they are feeling
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Multivitamins usage in pregravidal preparation Participants start use of Elevit multiple micronutrient (MMN) before pregnancy. |
Dietary Supplement: Multivitamins (Elevit, BAY987808)
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.
Other Names:
Dietary Supplement: Multivitamins (Elevit, BAY2906300)
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.
Other Names:
Drug: Multivitamins (Elevit, BAY987386)
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.
Other Names:
|
| Multivitamins usage during pregnancy Participants start use of Elevit multiple micronutrient (MMN) in the first trimester of pregnancy. |
Dietary Supplement: Multivitamins (Elevit, BAY987808)
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.
Other Names:
Dietary Supplement: Multivitamins (Elevit, BAY2906300)
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.
Other Names:
Drug: Multivitamins (Elevit, BAY987386)
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.
Other Names:
|
| Folic acid usage during pregnancy Participants use folic acid in accordance with clinical guidelines. |
Dietary Supplement: Folic acid
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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Normally Completed Pregnancies [Up to 18 Months]
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.
- Number of Participants with Maternal Anemia of Any Severity in Third Trimester (Hb<110g/L) [Up to 18 Months]
- Number of Participants with Preeclampsia of Any Severity [Up to 18 Months]
Preeclampsia is defined (arterial hypertension 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.
- Number of Participants with Small-for-gestational Newborns [Up to 18 Months]
Small for gestational age is defined as a newborn with weigh less than 10th percentile of normal weigh for gestational age.
- Number of Participants Having Low and Very Low Birth Weight Newborns [Up to 18 Months]
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; Babies weighing less than 1000 grams at birth are considered as extremely low birth weight.
- Change in Mean Score of Quality of Life Gravidarum (QoL-Grav) from 1st to 3rd Trimester [Up to 12 Months, At First and Third Trimester of Pregnancy]
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.
Secondary Outcome Measures
- Number of Participants with Severe Maternal Anemia [Up to 18 Months]
- Usage of Iron Medications for the Purposes of Anemia Treatment [Up to 12 Months]
- Change of Red Blood cells (RBC) Count from 1st to 3rd Trimester [Up to 12 Months, At First and Third Trimester of Pregnancy]
- Change of Mean Hemoglobin (Hgb) Concentration from 1st to 3rd Trimester [Up to 12 Months, At First and Third Trimester of Pregnancy]
- Number of Participants with Preterm Birth [Up to 12 Months]
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.
- Number of Participants with Fetal Growth Restriction (FGR) during 3rd Trimester [Up to 12 Months]
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.
- Number of Participants with Post-term Birth (Over 42 Weeks) [Up to 12 Months]
Post-term pregnancy is defined as pregnancy that has extended to or beyond 42 weeks of gestation (294 days).
- Number of Participants with Gestational Diabetes (GD) [Up to 12 Months]
GD - hyperglycemia, first diagnosed during pregnancy and not meeting criteria of manifested diabetes melitus (fasting glucose ≥7 mmol/l, HbA1c ≥ 6,5%, glucose in plasma at any time ≥ 11,1 mmol/l).
- Number of Participants with Confirmed Glucose Intolerance during 3rd Trimester [Up to 12 months]
- Number of Participants with Congenital Malformations [Up to 12 Months]
Congenital anomalies can be defined as structural or functional anomalies that occur during intrauterine life.
- Number of Participants with Fetal Macrosomia [Up to 12 Months]
Fetal macrosomia is a condition in which a fetus is larger than average-the birth weight is more than 4,000 grams (8 pounds, 13 ounces).
- Number of Participants with Excessive Vomiting in Pregnant Women [Up to 12 months]
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.
- Number of Pregnancy within 6 Months of Periconceptional Supplementation in Women with Different Levels of Fertile Function [Up to 6 Months]
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)
- Number of Participants with Spontaneous Miscarriage during 1st Trimester [Up to 12 Months]
Spontaneous miscarriage is the loss of pregnancy naturally before twenty weeks of gestation.
- Normal Weight Gain in Newborns in the First Month of Life in accordance with WHO Child Growth Standards [Up to 3 Months]
- Number of Participants with Different Breastfeeding in the First Month after Delivery [Up to 3 Months]
Including exclusive breastfeeding, mixed feeding and artificial feeding. Exclusive breastfeeding means that the infant receives only breast milk. No other liquids or solids are given - not even water - with the exception of oral rehydration solution, or drops/syrups of vitamins, minerals or medicines; Mixed/Partial breastfeeding means giving a baby some breastfeeds, and some artificial feeds, either milk or cereal, or other food; Artificial/Replacement feeding means the process of feeding a child who is not receiving any breast milk with a diet that provides all the nutrients the child needs.
Eligibility Criteria
Criteria
Inclusion Criteria:
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A woman aged 18 through 45 (inclusive) who is planning a pregnancy or with an already confirmed pregnancy with pregnancy term up to 12 weeks (pregnancy was confirmed by laboratory and/or ultrasound method).
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Decision to use Elevit® MMN or monocomponent supplementation of folic acid was made independent of study participation, and made prior to inclusion into this study.
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Provided signed Informed Consent to participate in the study
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Ability to understand and follow study-related instructions.
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Be willing and able to participate in all scheduled visits, treatment plan, laboratory tests and other trial procedures according to the study protocol and the standard medical practice.
Exclusion Criteria:
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Concurrent participation in interventional or other non-interventional study.
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The gestation period is more than 12 weeks.
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Taking any folate-containing products other than Elevit® for three months prior to enrollment in the study.
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Usage of other than Elevit Multiple Micronutrient product.
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Malignant neoplasms at present or in history.
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History of pregnancy with congenital malformations.
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Contraindications to the use of MMN Elevit specified in the approved instructions for use (for the medicinal product "Elevit® Pronatal") or leaflet (for dietary supplements "Elevit® planning and first trimester" and dietary supplements "Second and Third Trimester" of the trademark " Elevit®").
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Concomitant diseases in the stage of decompensation.
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Multiple pregnancy diagnosed before enrollment.
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Other pathological conditions that make it impossible for the subject to participate in the program (by the decision of the attending physician).
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Member or first-degree relative of study staff or the Sponsor directly involved in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Many Locations | Multiple Locations | Belarus | ||
| 2 | Many Locations | Multiple Locations | Belarus | ||
| 3 | Many Locations | Multiple Locations | Kazakhstan | ||
| 4 | Many Locations | Multiple Locations | Kazakhstan | ||
| 5 | Many Locations | Multiple Locations | Russian Federation | ||
| 6 | Many Locations | Multiple Locations | Uzbekistan | ||
| 7 | Many Locations | Multiple Locations | Uzbekistan |
Sponsors and Collaborators
- Bayer
Investigators
- Study Chair: 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21967