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

NCT ID: NCT05062044

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-07-24

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Multivitamins usage in pregravidal preparation

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

Multivitamins (Elevit, BAY987808)

Intervention Type: 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.

Multivitamins (Elevit, BAY2906300)

Intervention Type: 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.

Multivitamins (Elevit, BAY987386)

Intervention Type: 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.

Multivitamins usage during pregnancy

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

Multivitamins (Elevit, BAY987808)

Intervention Type: 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.

Multivitamins (Elevit, BAY2906300)

Intervention Type: 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.

Multivitamins (Elevit, BAY987386)

Intervention Type: 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.

Folic acid usage during pregnancy

Participants use folic acid in accordance with clinical guidelines.

Folic acid

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Elevit® planning and the first trimester; Second and Third Trimesters under Elevit®; Elevit® Pronatal

Eligibility Criteria

Inclusion Criteria

• 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).
• 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.
• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gennady T. Sukhikh, Dr. Medical Science, Professor

Role: STUDY_CHAIR

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.

Locations

Many Locations

Multiple Locations, , Kazakhstan

Many Locations

Multiple Locations, , Russia

Many Locations

Multiple Locations, , Uzbekistan

Countries

Kazakhstan; Russia; Uzbekistan

Related Links

https://clinicaltrials.bayer.com/

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.

Other Identifiers

21967

Identifier Type: -

Identifier Source: org_study_id