Clinical trial NCT05062044: A Study to Gather Information About the Progress and Outcomes of Pregnancy in Women Using Various Vitamin Support Plans Before and During Pregnancy
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2021-09-30
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Number of participants with normally completed pregnancies
timeFrame: Up to 18 months
measure: Number of participants with maternal anemia of any severity in third trimester (hemoglobin [Hb] <110 g/L)
timeFrame: Up to 18 months
measure: Number of participants with preeclampsia of any severity
timeFrame: Up to 18 months
measure: Number of participants with small-for-gestational newborns
timeFrame: Up to 18 months
measure: Number of participants having low and very low birth weight newborns
timeFrame: Up to 18 months
measure: Mean and change in score of quality of life gravidarum (QoL-Grav) in first to third trimester
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number and severity of anemia at any trimesters
timeFrame: Up to 18 months
measure: Number of usage of iron medications for the purposes of anemia
timeFrame: Up to 12 months
measure: Change of anemia severity from first to third trimester
timeFrame: Up to 12 months
measure: Number of participants with preterm birth
timeFrame: Up to 12 months
measure: Number of participants with fetal growth restriction during third trimester
timeFrame: Up to 12 months
measure: Number of participants with post-term birth
timeFrame: Up to 12 months
measure: Number of participants with gestational diabetes
timeFrame: Up to 12 months
measure: Number of participants with confirmed glucose intolerance during third trimester
timeFrame: Up to 12 months
measure: Number of participants with congenital malformations
timeFrame: Up to 12 months
measure: Number of participants with fetal macrosomia
timeFrame: Up to 12 months
measure: Number of participants with excessive vomiting in pregnant women
timeFrame: Up to 12 months
measure: Number of pregnancy within 6 months of periconceptional supplementation in women with different levels of fertile function
timeFrame: Up to 18 months
measure: Number of participants with spontaneous abortion/miscarriage
timeFrame: Up to 12 months
measure: Normal weight gain in newborns in the first month of life in accordance with WHO child growth standards
timeFrame: Up to 12 months
measure: Number of participants with exclusive breastfeeding, mixed and artificial feeding in the first month after delivery
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Kazakhstan
facility: Many Locations
city: Multiple Locations
country: Russian Federation
facility: Many Locations
city: Multiple Locations
country: Uzbekistan
facility: Many Locations
Study officials:
affiliation: 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.
name: Gennady T. Sukhikh, Dr. Medical Science, Professor
role: STUDY_CHAIR
References: