Prevention of Vitamin Deficiency During and/or Before PregnancyNCT05062044
A Study to Gather Information About the Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Plans Before and During Pregnancy
An observational study of Prevention of Vitamin Deficiency During and/or Before Pregnancy, run by Bayer at 3 sites in 3 countries.
Trial 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. 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
- Prevention of Vitamin Deficiency During and/or Before Pregnancy
- What is being tested?
- Multivitamins (Elevit, BAY987808), Multivitamins (Elevit, BAY2906300) and Multivitamins (Elevit, BAY987386)
- How many people
- 1,500 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Dec 2021to 24 Jul 2025
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Prospective International Multicenter Observational Cohort Study Evaluating Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Regimens Before and During Pregnancy (UNONA Study)
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.
Read more
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.
- Being tested
- Multivitamins (Elevit, BAY987808), Multivitamins (Elevit, BAY2906300), Multivitamins (Elevit, BAY987386), Folic acid
- Keywords
- Preconceptional preparation, Pregnancy, Folic acid, Multivitamins, Vitamin deficiency, Supplementation, Anemia during pregnancy, Fetus growth and development
- Medical subject headings
- Avitaminosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multivitamins (Elevit, BAY987808)Dietary supplement
Also called Elevit® planning and the first trimester
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)Dietary supplement
Also called Second and Third Trimesters under Elevit®
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)Drug
Also called Elevit® Pronatal
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 acidDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Multivitamins usage in pregravidal preparation | Participants start use of Elevit multiple micronutrient (MMN) before pregnancy. Receives: 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. Receives: 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. Receives: Dietary Supplement: Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
Number of participants with maternal anemia of any severity in third trimester (hemoglobin [Hb] <110 g/L)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (15)
Number and severity of anemia at any trimesters
Measured: Up to 18 months
Number of usage of iron medications for the purposes of anemia
Measured: Up to 12 months
Change of anemia severity from first to third trimester
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Up to 12 months
Number of participants with gestational diabetes
Measured: Up to 12 months
Number of participants with confirmed glucose intolerance during third trimester
Measured: 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)".
Measured: 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.).
Measured: 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.
Measured: 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)
Measured: Up to 18 months
Number of participants with spontaneous abortion/miscarriage
Spontaneous miscarriage is the loss of pregnancy naturally before twenty weeks of gestation.
Measured: 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.
Measured: Up to 12 months
Number of participants with exclusive breastfeeding, mixed and artificial feeding in the first month after delivery
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start1 Dec 2021
- Primary completion13 Apr 2025
- Study completion24 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Vitamin Deficiency During and/or Before PregnancyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gennady T. Sukhikh, Dr. Medical Science, Professor, 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.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062044
- Sponsor's protocol ID
- 21967
- Status last verified
- Sep 2025
- First submitted
- 21 Sep 2021
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective International Multicenter Observational Cohort Study Evaluating Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Regimens Before and During Pregnancy (UNONA Study)
- ClinicalTrials.gov ID
- NCT05062044
- Acronym / sponsor ID
- 21967
- Keywords
- Preconceptional preparation, Pregnancy, Folic acid, Multivitamins, Vitamin deficiency, Supplementation, Anemia during pregnancy, Fetus growth and development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 13 Apr 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 30 Sep 2021 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multivitamins usage in pregravidal preparation | – | Dietary Supplement: Multivitamins (Elevit, BAY987808), Dietary Supplement: Multivitamins (Elevit, BAY2906300), Drug: Multivitamins (Elevit, BAY987386)Participants start use of Elevit multiple micronutrient (MMN) before pregnancy. |
| Multivitamins usage during pregnancy | – | Dietary Supplement: Multivitamins (Elevit, BAY987808), Dietary Supplement: Multivitamins (Elevit, BAY2906300), Drug: Multivitamins (Elevit, BAY987386)Participants start use of Elevit multiple micronutrient (MMN) in the first trimester of pregnancy. |
| Folic acid usage during pregnancy | – | Dietary Supplement: Folic acidParticipants use folic acid in accordance with clinical guidelines. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Multivitamins (Elevit, BAY987808)Also: Elevit® planning and the first trimesterFollowing 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. | Dietary supplement | Multivitamins usage during pregnancy, Multivitamins usage in pregravidal preparation |
| Multivitamins (Elevit, BAY2906300)Also: Second and Third Trimesters under Elevit®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. | Dietary supplement | Multivitamins usage during pregnancy, Multivitamins usage in pregravidal preparation |
| Multivitamins (Elevit, BAY987386)Also: Elevit® PronatalFollowing 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. | Drug | Multivitamins usage during pregnancy, Multivitamins usage in pregravidal preparation |
| Folic acidFollowing 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. | Dietary supplement | Folic acid usage during pregnancy |
Primary outcome
Number of participants with normally completed pregnancies
Time frame: 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 (hemoglobin [Hb] <110 g/L)
Time frame: Up to 18 months
Number of participants with preeclampsia of any severity
Time frame: Up to 18 months
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.
Number of participants with small-for-gestational newborns
Time frame: 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
Time frame: 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.
Mean and change in score of quality of life gravidarum (QoL-Grav) in first to third trimester
Time frame: Up to 12 months
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.
15 secondary outcomes
Number and severity of anemia at any trimesters
Time frame: Up to 18 months
Number of usage of iron medications for the purposes of anemia
Time frame: Up to 12 months
Change of anemia severity from first to third trimester
Time frame: Up to 12 months
Number of participants with preterm birth
Time frame: Up to 12 months
Number of participants with fetal growth restriction during third trimester
Time frame: Up to 12 months
Number of participants with post-term birth
Time frame: Up to 12 months
Number of participants with gestational diabetes
Time frame: Up to 12 months
Number of participants with confirmed glucose intolerance during third trimester
Time frame: Up to 12 months
Number of participants with congenital malformations
Time frame: Up to 12 months
Number of participants with fetal macrosomia
Time frame: Up to 12 months
Number of participants with excessive vomiting in pregnant women
Time frame: Up to 12 months
Number of pregnancy within 6 months of periconceptional supplementation in women with different levels of fertile function
Time frame: Up to 18 months
Number of participants with spontaneous abortion/miscarriage
Time frame: Up to 12 months
Normal weight gain in newborns in the first month of life in accordance with WHO child growth standards
Time frame: Up to 12 months
Number of participants with exclusive breastfeeding, mixed and artificial feeding in the first month after delivery
Time frame: Up to 12 months
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 4 Sep 2025.
- Individual participant dataSharing planned: No. 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.
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.
Gennady T. Sukhikh, Dr. Medical Science, Professor 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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prevention of Vitamin Deficiency During and/or Before Pregnancy, run by Bayer at 3 sites in 3 countries.
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 5 inclusion and 11 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 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Kazakhstan, Russia, Uzbekistan. 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?
Number of participants with normally completed pregnancies (time frame: Up to 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.