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NCT Number: NCT05062044

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations, Multiple Locations, Kazakhstan

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Elevit® planning and the first trimester

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.

Other names: Second and Third Trimesters under Elevit®

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.

Other names: Elevit® Pronatal

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.

Primary outcomes

  1. 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.

  2. Number of participants with maternal anemia of any severity in third trimester (hemoglobin [Hb] <110 g/L)

    Time frame: Up to 18 months

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Number and severity of anemia at any trimesters

    Time frame: Up to 18 months

  2. Number of usage of iron medications for the purposes of anemia

    Time frame: Up to 12 months

  3. Change of anemia severity from first to third trimester

    Time frame: Up to 12 months

  4. Number of participants with preterm birth

    Time frame: 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.

  5. Number of participants with fetal growth restriction during third trimester

    Time frame: 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.

  6. Number of participants with post-term birth

    Time frame: Up to 12 months

    Post-term pregnancy is defined as pregnancy that has extended to or beyond 42 weeks of gestation (294 days).

  7. Number of participants with gestational diabetes

    Time frame: Up to 12 months

  8. Number of participants with confirmed glucose intolerance during third trimester

    Time frame: Up to 12 months

  9. Number of participants with congenital malformations

    Time frame: Up to 12 months

    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)".

  10. Number of participants with fetal macrosomia

    Time frame: Up to 12 months

    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.).

  11. Number of participants with excessive vomiting in pregnant women

    Time frame: 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.

  12. Number of pregnancy within 6 months of periconceptional supplementation in women with different levels of fertile function

    Time frame: Up to 18 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)

  13. Number of participants with spontaneous abortion/miscarriage

    Time frame: Up to 12 months

    Spontaneous miscarriage is the loss of pregnancy naturally before twenty weeks of gestation.

  14. Normal weight gain in newborns in the first month of life in accordance with WHO child growth standards

    Time frame: Up to 12 months

    WHO stands for world health organization.

  15. Number of participants with exclusive breastfeeding, mixed and artificial feeding in the first month after delivery

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2021
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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