CompletedNot Applicable

MTHFR Mutation and Concentration of B12,Folic Acid,Homocysteine and HS CRP in the Blood of Pregnant Women With GDM.

Bosnia and Herzegovina100 participantsStarted 2020-09-01

Plain-language summary

Research hypothesis: * pregnant women with gestational diabetes have elevated serum CRP values and homocysteine compared to pregnant women with normal glucose metabolism * Elevated CRP and homocysteine values are associated with poorer perinatal outcome. * reduced concentrations of folic acid and vitamin B 12 are associated with higher homocitein values * Carriers of the MTHFR gene mutation have higher homocysteine concentrations

Who can participate

Age range

18 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age of respondents from 18 to 35 years * Single pregnancies BMI from 18.5 to 29.9 kg / m 2 Exclusion Criteria: * Diagnosis of acute and chronic inflammatory diseases * Pregestational diabetes * Chronic hypertension * Multiple pregnancies * Smoking

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Whether increased hs crp and homocysteine values are associated with poorer perinatal outcome

Timeframe: Between 24 and 28 weeks of gestation

carriers of the MTHFR gene mutation have higher serum homocysteine concentrations in the blood

Timeframe: Between 24 and 28 weeks of gestation

Trial details

NCT IDNCT04952324

SponsorUniversity of Mostar

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12-31

View on ClinicalTrials.gov More Gestational Diabetes trials