Mineral Status in Pregnant Women

NCT03598361 | Recruiting

• 1 other identifier: 297/17
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

Ensuring an adequate supply of nutrients, which include trace elements, is particularly important in pregnancy. Both deficiency and excess of trace elements in the body can interfere with conception and maintaining a healthy pregnancy. The effects of malnutrition and shortages in fetal life may increase the risk of miscarriages, congenital malformations, premature births, intrauterine fetal growth restriction (IUGR) and more frequent perinatal mortality. Nutritional deficiencies during fetal development may also have long-term consequences for the child, such as disorders in his biological and psychomotor development. In women of procreative age, an adequate supply of minerals, especially iron, calcium, zinc, magnesium and copper, is very important. The results of clinical trials indicate an association of anemia in pregnant women with premature delivery and low birth weight of a newborn. Calcium deficiency leads to the development of hypertension in pregnancy (including preeclampsia) and increases the risk of premature birth. Deficiency of zinc and copper in the mother's body is associated with complications of pregnancy and childbirth and affects inappropriate fetal development. The deficiency of these mineral components is often observed in young women-potential mothers. Increasing during pregnancy the need for nutrients and abnormal nutrition, intensify the deficiencies of minerals and affect the abnormal development of the fetus. It seems that during the course of pregnancy, changes in the mineral nutrition of women can be observed, which is why it is important to monitor this condition in the subsequent months of pregnancy. Due to the above, the aim of the planned research is to determine the nutrition and nutritional status of women in the subsequent trimesters of pregnancy. Obtained results will allow to formulate appropriate nutritional recommendations and / or indicate the need to implement appropriate mineral supplementation for women in every trimester of pregnancy.

Conditions

Pregnancy; Disorder, Blood

Keywords

pregnancy outcomes, minerals

Outcome Measures

Primary Outcomes (1)

• minerals (Ca, Mg, Fe, Zn)

  measure minerals in serum, hair, amniotic fluid

  1 year

Secondary Outcomes (8)

• maternal anthropometric parameters

  2 years

• fetal body weight

  2 years

• fetal head circumference

  2 years

• fetal biparietal diameter

  2 years

• prenatal diagnosis: PAPP-A

  2 years

Eligibility Criteria

• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A group of approximately 300 women is planned to be included in the study in the first trimester of pregnancy (up to 14 weeks of pregnancy).

You may qualify if:

• Diagnosed intrauterine pregnancy until week 14.
• Single pregnancy without congenital malformations in ultrasound examination.
• Lack of exponents threatening miscarriage (bleeding, lower abdominal pain, chorionic hematoma).
• Lack of use of drugs affecting the mineral metabolism of the body.
• Signing consent to participate in the study.

You may not qualify if:

• Ectopic or heterotopic pregnancy.
• Twin pregnancy (or other multiple pregnancy).
• Obstetric load in the direction of numerous miscarriages, premature births under 34 weeks, pregnancy, fetal growth disorders (hypotrophy, macrosomia).
• Congenital and /or genetic defects found in current pregnancy or in the patient.
• Supply of drugs affecting the mineral metabolism of the body.

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Sciences

Poznan, 60-624, Poland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples hair amniotic fluid

Central Study Contacts

Joanna Suliburska, Assoc. Prof.

CONTACT

+48 618487344; jsulibur@up.poznan.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator

Study Record Dates

• First Submitted: July 1, 2018
• First Posted: July 26, 2018
• Study Start: March 20, 2018
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

PL (1)