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Идёт набор NCT05754645

The Microbiome in (Non-) Obese Pregnancy and Pregnancy Outcomes

— Наблюдательное Obesity, Maternal Pregnancy Complications Gut Microbiota

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Blood withdrawal.
Кому может быть актуально
Состояния в реестре: Obesity, Maternal, Pregnancy Complications, Gut Microbiota. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The PROMOTE Study, a Pilot: The Characterization of the Microbiome in Pregnancy and Prediction of Pregnancy Outcomes

Обзор

This research aims to elucidate an underlying mechanism of maternal obesity induced pregnancy and longterm health complications for mothers and their offspring.

Подробное описание

With the increasing global prevalence of obesity, pregnancy problems related to maternal obesity are increasingly occurring. Microbial gut symbiosis plays an important role in health, with dysbiosis being associated with diseases such as obesity. Of interest are pregnancy, dietary patterns and pre- or probiotics that affect the composition of the gut microbiome. The microbiome itself can influence many physiological processes, such as immune responses (production of microbial products) and the nutrient-dependent one-carbon metabolism. It is hypothesized that gut dysbiosis, due to maternal obesity, during pregnancy can be considered an endogenous chronic stressor causing impaired immune response and carbon metabolism. Both processes result in excessive oxidative stress, detrimental to cell replication, differentiation and epigenetic programming of maternal and infant tissues. Together, these biological disturbances contribute to placental and vascular dysfunction, leading to an increased risk of preeclampsia or gestational diabetes mellitus. Vertical (during pregnancy) and horizontal (during delivery) transmission of gut dysbiosis from mother to newborn and epigenetic placental and foetal changes may ultimately lead to macrosomia and obesity in children. Therefore, the differences between the gut and vaginal microbiome, maternal and fetal immune responses and one-carbon metabolism in obese versus normal-weight pregnant women will be analysed.

Вмешательства

  • Другое Blood withdrawal
    venous punction with blood withdrawal Vaginal and rectal swab, done by patient itself

Первичные конечные точки

  • Gut and vaginal microbiota [Срок оценки: Preconceptional (up to 1 year before pregnancy)]
  • Gut and vaginal microbiota [Срок оценки: First trimester (between 7-12 weeks gestational age)]
  • Gut and vaginal microbiota [Срок оценки: Second trimester (between 22-25 weeks gestational age)]
  • Gut and vaginal microbiota [Срок оценки: Third trimester (between 30-32 weeks gestational age)]
  • Gut and vaginal microbiota [Срок оценки: Antepartum (during delivery)]
  • Gut and vaginal microbiota [Срок оценки: Postpartum (6-8 weeks post delivery)]
Вторичные конечные точки (12)
  • Gut virome [Срок оценки: Preconceptional (up to 1 year before pregnancy)]
  • Gut virome [Срок оценки: First trimester (between 7-12 weeks gestational age)]
  • Gut virome [Срок оценки: Second trimester (between 22-24 weeks gestational age)]
  • Gut virome [Срок оценки: Third trimester (between 30-32 weeks gestational age)]
  • Gut virome [Срок оценки: Antepartum (during delivery)]
  • Gut virome [Срок оценки: Postpartum (6-8 weeks post delivery)]
  • Maternal immune response [Срок оценки: Preconceptional (up to 1 year before pregnancy)]
  • Maternal immune response [Срок оценки: First trimester (between 7-12 weeks gestational age)]
  • Maternal immune response [Срок оценки: Second trimester (between 22-24 weeks gestational age)]
  • Maternal immune response [Срок оценки: Third trimester (between 30-32 weeks gestational age)]
  • Maternal immune response [Срок оценки: Antepartum (during delivery)]
  • Maternal immune response [Срок оценки: Postpartum (6-8 weeks post delivery)]

Критерии участия

Критерии включения

  • Participation in Predict study
  • Preconceptional women who wish to become pregnant or pregnancy <13 weeks of gestational age.
  • BMI > 30 kg/m2 or 18-25 kg/m2
  • Understanding of Dutch in speaking and reading
  • Willingness to give written informed consent

Критерии исключения

  • Age < 18 years and > 45 years.
  • ≥13 weeks of gestational age
  • Multiple pregnancy
  • Smoking
  • Gastro-intestinal diseases, heart diseases, liver, pancreas and kidney diseases.
  • Use of antibiotics < 2 weeks before sampling
  • Pre-existent diabetes mellitus

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Erasmus MC — Rotterdam

Публикации

  • Rousian M, Schoenmakers S, Eggink AJ, Gootjes DV, Koning AHJ, Koster MPH, Mulders AGMGJ, Baart EB, Reiss IKM, Laven JSE, Steegers EAP, Steegers-Theunissen RPM. Cohort Profile Update: the Rotterdam Periconceptional Cohort and embryonic and fetal measurements using 3D ultrasound and virtual reality techniques. Int J Epidemiol. 2021 Nov 10;50(5):1426-1427l. doi: 10.1093/ije/dyab030. No abstract avail PMID 34097026
  • Gaillard R, Durmus B, Hofman A, Mackenbach JP, Steegers EA, Jaddoe VW. Risk factors and outcomes of maternal obesity and excessive weight gain during pregnancy. Obesity (Silver Spring). 2013 May;21(5):1046-55. doi: 10.1002/oby.20088. PMID 23784909
  • Mission JF, Marshall NE, Caughey AB. Pregnancy risks associated with obesity. Obstet Gynecol Clin North Am. 2015 Jun;42(2):335-53. doi: 10.1016/j.ogc.2015.01.008. PMID 26002170
  • Singh AS, Mulder C, Twisk JW, van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev. 2008 Sep;9(5):474-88. doi: 10.1111/j.1467-789X.2008.00475.x. Epub 2008 Mar 5. PMID 18331423
  • Tanvig M. Offspring body size and metabolic profile - effects of lifestyle intervention in obese pregnant women. Dan Med J. 2014 Jul;61(7):B4893. PMID 25123127
  • Kuhle S, Muir A, Woolcott CG, Brown MM, McDonald SD, Abdolell M, Dodds L. Maternal pre-pregnancy obesity and health care utilization and costs in the offspring. Int J Obes (Lond). 2019 Apr;43(4):735-743. doi: 10.1038/s41366-018-0149-3. Epub 2018 Jul 13. PMID 30006584
  • Morgan KL, Rahman MA, Macey S, Atkinson MD, Hill RA, Khanom A, Paranjothy S, Husain MJ, Brophy ST. Obesity in pregnancy: a retrospective prevalence-based study on health service utilisation and costs on the NHS. BMJ Open. 2014 Feb 27;4(2):e003983. doi: 10.1136/bmjopen-2013-003983. PMID 24578535
  • Elderman M, Hugenholtz F, Belzer C, Boekschoten M, de Haan B, de Vos P, Faas M. Changes in intestinal gene expression and microbiota composition during late pregnancy are mouse strain dependent. Sci Rep. 2018 Jul 3;8(1):10001. doi: 10.1038/s41598-018-28292-2. PMID 29968760

Идентификаторы

NCT: NCT05754645 · NL80155.078.22/OZBS72.21318

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗