A Study to Gather Information About the Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Plans Before and During Pregnancy

NCT05062044 | Completed

• 1 other identifier: 21967
• Study Type: observational
• Target: 1,500
• Locations: 3 countries
• Sites: 3

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:

• calculate how many women give birth without any complications between weeks 37 and 42 of their pregnancies
• calculate how many women have low levels of red blood cells in the blood during the third trimester of their pregnancies
• 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
• calculate how many women give birth to babies who weigh less than expected at the time of their birth
• 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.

Conditions

Prevention of Vitamin Deficiency During and/or Before Pregnancy

Keywords

Preconceptional preparation; Pregnancy; Folic acid; Multivitamins; Vitamin deficiency; Supplementation; Anemia during pregnancy; Fetus growth and development

Outcome Measures

Primary Outcomes (6)

• 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

  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

Secondary Outcomes (15)

• 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

  Up to 12 months

• Number of participants with preterm birth

  Up to 12 months

• Number of participants with fetal growth restriction during third trimester

  Up to 12 months

Study Arms (3)

Multivitamins usage in pregravidal preparation

Participants start use of Elevit multiple micronutrient (MMN) before pregnancy.

Dietary Supplement: Multivitamins (Elevit, BAY987808); Dietary Supplement: Multivitamins (Elevit, BAY2906300); Drug: Multivitamins (Elevit, BAY987386)

Multivitamins usage during pregnancy

Participants start use of Elevit multiple micronutrient (MMN) in the first trimester of pregnancy.

Dietary Supplement: Multivitamins (Elevit, BAY987808); Dietary Supplement: Multivitamins (Elevit, BAY2906300); Drug: Multivitamins (Elevit, BAY987386)

Folic acid usage during pregnancy

Participants use folic acid in accordance with clinical guidelines.

Dietary Supplement: Folic acid

Interventions

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.

Also known as: Elevit® planning and the first trimester

Multivitamins usage during pregnancy; Multivitamins usage in pregravidal preparation

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.

Also known as: Second and Third Trimesters under Elevit®

Multivitamins usage during pregnancy; Multivitamins usage in pregravidal preparation

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.

Also known as: Elevit® Pronatal

Multivitamins usage during pregnancy; Multivitamins usage in pregravidal preparation

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.

Folic acid usage during pregnancy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).
• Provided signed Informed Consent to participate in the study
• Ability to understand and follow study-related instructions.
• 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.

You may not qualify if:

• Concurrent participation in interventional or other non-interventional study.
• The gestation period is more than 12 weeks.
• Taking any folate-containing products other than Elevit® for three months prior to enrollment in the study.
• Usage of other than Elevit Multiple Micronutrient product.
• Malignant neoplasms at present or in history.
• History of pregnancy with congenital malformations.
• 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®").
• Concomitant diseases in the stage of decompensation.
• Multiple pregnancy diagnosed before enrollment.
• Other pathological conditions that make it impossible for the subject to participate in the program (by the decision of the attending physician).
• Member or first-degree relative of study staff or the Sponsor directly involved in the study.

Sponsors & Collaborators

• Bayer: lead

Study Sites (3)

Many Locations

Multiple Locations, Kazakhstan

Location

Many Locations

Multiple Locations, Russia

Location

Many Locations

Multiple Locations, Uzbekistan

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

MeSH Terms

Conditions

Avitaminosis

Interventions

Geritol; Folic Acid

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: December 1, 2021
• Primary Completion: April 13, 2025
• Study Completion: July 24, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1); RU (1); UZ (1)