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Obesity, MaternalPROMOTENCT05754645

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

An observational study of Obesity, Maternal and Pregnancy Complications, run by Erasmus Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Blood withdrawal
How many people
110 participants
Where
1 siteNetherlands
Study dates
21 Jul 2022to 21 Aug 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: This pilot study is embedded in the Rotterdam Periconceptional Cohort study (Predict study). The Predict study population includes preconceptional or pregnant women > 18 years and < 45 years old visiting the Erasmus MC and that are willing to participate. We will select the participants, that meet our undermentioned inclusion criteria, for our study from this cohort: 50 women with a BMI > 30 kg/m2 (cases) and 50 women with a BMI ranging 18-25 kg/m2 (controls) and their neonates. We will longitudinally sample first/2nd/3rd/postpartum, 100 women, in addition we will include 10 preconceptional women with BMI > 30 kg/m2 and 10 preconceptional women with BMI 18-25 kg/m2, these participants do not necessarily have to conceive a pregnancy in order to remain in the study (these women are part of the preconceptional Predict population).

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Nicole Schenkelaars, MD contact

+31627530793

n.schenkelaars@erasmusmc.nl

Netherlands1 site, 1 recruiting

  • Erasmus MC

    Rotterdam, South Holland, 3015GD

    Nicole Schenkelaars, MD, +31627530793, n.schenkelaars@erasmusmc.nl

    Ann M. Vanrolleghem, 0107038923, a.vanrolleghem@erasmusmc.nl

    Recruiting

Other trials in Netherlands

About this study

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

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

Read the detailed description

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.

Being tested
Blood withdrawal
Medical subject headings
Pregnancy in Obesity, Pregnancy Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood withdrawalOther

    Also called Vaginal/rectal swabs

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

Study groups in NCT05754645
Study groupRoleWhat they receive
110 women60 women with a BMI between 18,5-25 kg/m2, of which 10 preconceptional 60 women with a BMI > 30 kg/m2, of which 10 preconceptional
Receives: Other: Blood withdrawal

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut and vaginal microbiota

    Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16S ribosomal ribonucleic acid (16SrRNA) gene amplification sequencing (V6-V8). Sequences will be assigned to operational taxonomic units (OTUs).

    Measured: Preconceptional (up to 1 year before pregnancy)

  2. Gut and vaginal microbiota

    Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16SrRNA gene amplification sequencing (V6-V8). Sequences will be assigned to OTUs.

    Measured: First trimester (between 7-12 weeks gestational age)

  3. Gut and vaginal microbiota

    Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16SrRNA gene amplification sequencing (V6-V8). Sequences will be assigned to OTUs.

    Measured: Second trimester (between 22-25 weeks gestational age)

  4. Gut and vaginal microbiota

    Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16SrRNA gene amplification sequencing (V6-V8). Sequences will be assigned to OTUs.

    Measured: Third trimester (between 30-32 weeks gestational age)

  5. Gut and vaginal microbiota

    Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16SrRNA gene amplification sequencing (V6-V8). Sequences will be assigned to OTUs.

    Measured: Antepartum (during delivery)

  6. Gut and vaginal microbiota

    Composition of gut and vaginal microbiota derived by swab sampling, bacteriome profiles will be assessed by 16SrRNA gene amplification sequencing (V6-V8). Sequences will be assigned to OTUs.

    Measured: Postpartum (6-8 weeks post delivery)

Secondary outcomes (59)

  1. Gut virome

    Composition of gut virome, obtained by a rectal swab

    Measured: Preconceptional (up to 1 year before pregnancy)

  2. Gut virome

    Composition of gut virome, obtained by a rectal swab

    Measured: First trimester (between 7-12 weeks gestational age)

  3. Gut virome

    Composition of gut virome, obtained by a rectal swab

    Measured: Second trimester (between 22-24 weeks gestational age)

  4. Gut virome

    Composition of gut virome, obtained by a rectal swab

    Measured: Third trimester (between 30-32 weeks gestational age)

  5. Gut virome

    Composition of gut virome, obtained by a rectal swab

    Measured: Antepartum (during delivery)

  6. Gut virome

    Composition of gut virome, obtained by a rectal swab

    Measured: Postpartum (6-8 weeks post delivery)

  7. Maternal immune response

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

    Measured: Preconceptional (up to 1 year before pregnancy)

  8. Maternal immune response

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

    Measured: First trimester (between 7-12 weeks gestational age)

  9. Maternal immune response

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

    Measured: Second trimester (between 22-24 weeks gestational age)

  10. Maternal immune response

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

    Measured: Third trimester (between 30-32 weeks gestational age)

  11. Maternal immune response

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

    Measured: Antepartum (during delivery)

  12. Maternal immune response

    Responses of maternal immune system advanced oxidation protein products (AOPP)) measured in chloramine units per gram of protein (micromol/g) obtained by blood withdrawal and measured in the lab.

    Measured: Postpartum (6-8 weeks post delivery)

  13. Maternal immune response

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Preconceptional (up to 1 year before pregnancy)

  14. Maternal immune response

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: First trimester (between 7-12 weeks gestational age)

  15. Maternal immune response

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Second trimester (between 22-24 weeks gestational age)

  16. Maternal immune response

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Third trimester (between 30-32 weeks gestational age)

  17. Maternal immune response

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Antepartum (during delivery)

  18. Maternal immune response

    Tumor necrosis factor-alpha (TNF-alpha) measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Postpartum (6-8 weeks post delivery)

  19. Maternal immune response

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Preconceptional (up to 1 year before pregnancy)

  20. Maternal immune response

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: First trimester (between 7-12 weeks gestational age)

  21. Maternal immune response

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Second trimester (between 22-24 weeks gestational age)

  22. Maternal immune response

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Third trimester (between 30-32 weeks gestational age)

  23. Maternal immune response

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Antepartum (during delivery)

  24. Maternal immune response

    Interleukin-6 (IL-6), measured in picograms per milliliter, obtained by blood withdrawal and measured in the lab.

    Measured: Postpartum (6-8 weeks post delivery)

  25. Maternal immune response

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

    Measured: Preconceptional (up to 1 year before pregnancy)

  26. Maternal immune response

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

    Measured: First trimester (between 7-12 weeks gestational age)

  27. Maternal immune response

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

    Measured: Second trimester (between 22-24 weeks gestational age)

  28. Maternal immune response

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

    Measured: Third trimester (between 30-32 weeks gestational age)

  29. Maternal immune response

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

    Measured: Antepartum (during delivery)

  30. Maternal immune response

    high sensitive C-reactive protein(hsCRP), measured in mg/L, obtained by blood withdrawal and measured in the lab.

    Measured: Postpartum (6-8 weeks post delivery)

  31. Maternal metabolic response

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Preconceptional (up to 1 year before pregnancy)

  32. Maternal metabolic response

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: First trimester (between 7-12 weeks gestational age)

  33. Maternal metabolic response

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Second trimester (between 22-24 weeks gestational age)

  34. Maternal metabolic response

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Third trimester (between 30-32 weeks gestational age)

  35. Maternal metabolic response

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Antepartum (during delivery)

  36. Maternal metabolic response

    Markers of the one-carbon metabolism; folate, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Postpartum (6-8 weeks post delivery)

  37. Maternal metabolic response

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Preconceptional (up to 1 year before pregnancy)

  38. Maternal metabolic response

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: First trimester (between 7-12 weeks gestational age)

  39. Maternal metabolic response

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Second trimester (between 22-24 weeks gestational age)

  40. Maternal metabolic response

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Third trimester (between 30-32 weeks gestational age)

  41. Maternal metabolic response

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Antepartum (during delivery)

  42. Maternal metabolic response

    Markers of the one-carbon metabolism; Homocysteine, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Postpartum (6-8 weeks post delivery)

  43. Maternal metabolic response

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Preconceptional (up to 1 year before pregnancy)

  44. Maternal metabolic response

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: First trimester (between 7-12 weeks gestational age)

  45. Maternal metabolic response

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Second trimester (between 22-24 weeks gestational age)

  46. Maternal metabolic response

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Third trimester (between 30-32 weeks gestational age)

  47. Maternal metabolic response

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Antepartum (during delivery)

  48. Maternal metabolic response

    Markers of the one-carbon metabolism; B-vitamin 12, measured in micromol/l, obtained by blood withdrawal and measured in the lab.

    Measured: Postpartum (6-8 weeks post delivery)

  49. Clinical maternal outcome: gestational age

    Gestational age (amenorrhea duration) at delivery.

    Measured: Durante partum

  50. Clinical maternal outcome: pre-eclampsia

    Pre-eclampsia is defined as the combination of gestational hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg (Korotkoff V) occurring after 20 weeks of gestation gestational age, measured twice, in a woman who previously had normal blood pressure) with proteinuria (≥ 300 mg/24 hours).

    Measured: from 20 weeks of gestation to <8 weeks postpartum

  51. Clinical maternal outcome: hypertension

    Hypertension is defined as a systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg (Korotkoff V) occurring after 20 weeks of gestation gestational age, measured twice, in a woman who previously had normal blood pressure.

    Measured: from 20 weeks of gestation to <8 weeks postpartum

  52. Clinical maternal outcome: gestational diabetes

    Gestational diabetes defined as any form of hyperglycaemia detected during pregnancy, regardless ofwhether this abnormality disappears after pregnancy. Diagnosed through a 75 gr Oral Glucose Tolerance Test (OGTT) with a fasting venous value > 7 mmol/l or above 7.8 mmol/l after 2 hours.

    Measured: From the first positive pregnancy test to delivery

  53. Fetal growth

    Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.

    Measured: First trimester (Between 7-7+6 days of gestational age)

  54. Fetal growth

    Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.

    Measured: First trimester (Between 9-9+6 days of gestational age)

  55. Fetal growth

    Fetal growth trajectories, Crown-Rump-Length (CRL) obtained by using ultrasound imaging.

    Measured: First trimester (Between 11-11+6 days of gestational age)

  56. Fetal growth

    Fetal growth trajectories defined as Estimated Fetal Weight (EFW) (in grams) based on the measurements (in mm) of the Head circumference (HC), Biparietal diameter (BPD), Abdominal circumference (AC) and Femur length (FL) to be obtained/measured during the ultrasound.

    Measured: Second trimester (Between AD 22-25 weeks of gestational age)

  57. Fetal growth

    Fetal growth trajectories defined as Estimated Fetal Weight (EFW) (in grams) based on the measurements (in mm) of the Head circumference (HC), Biparietal diameter (BPD), Abdominal circumference (AC) and Femur length (FL) to be obtained/measured during the ultrasound.

    Measured: Third trimester (Between 30-33 weeks of gestational age)

  58. Histological placental function

    Histology of placenta: biopsies are taken within 2 days after delivery, these are snapfrozen in -80 degrees Celsius and assessed according to protocol by pathologist

    Measured: Postpartum (<2 days postpartum)

  59. Placental weight

    Placental weight measured (in grams), weighed on the scale.

    Measured: Postpartum (<2 days postpartum)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start21 Jul 2022
  3. Primary completion21 Aug 2025 (estimated)
  4. Study completion21 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05754645
Sponsor's protocol ID
NL80155.078.22/OZBS72.21318
Acronym
PROMOTE
Status last verified
Sep 2024
First submitted
24 Jan 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 available.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29968760

  • Schoenmakers S, Steegers-Theunissen R, Faas M. The matter of the reproductive microbiome. Obstet Med. 2019 Sep;12(3):107-115. doi: 10.1177/1753495X18775899. Epub 2018 May 17.

    PubMed 31523266

  • Turnbaugh PJ, Hamady M, Yatsunenko T, Cantarel BL, Duncan A, Ley RE, Sogin ML, Jones WJ, Roe BA, Affourtit JP, Egholm M, Henrissat B, Heath AC, Knight R, Gordon JI. A core gut microbiome in obese and lean twins. Nature. 2009 Jan 22;457(7228):480-4. doi: 10.1038/nature07540. Epub 2008 Nov 30.

    PubMed 19043404

  • Schenkelaars N, Wekema L, Faas MM, Steegers-Theunissen RPM, Schoenmakers S. Protocol of the PROMOTE study: characterization of the microbiome, the immune response, and one-carbon metabolism in preconceptional and pregnant women with and without obesity (an observational subcohort of the Rotterdam Periconception cohort). PLoS One. 2025 Apr 2;20(4):e0319618. doi: 10.1371/journal.pone.0319618. eCollection 2025.

    PubMed 40173397

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, Maternal and Pregnancy Complications, run by Erasmus Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicole Schenkelaars, MD (+31627530793, n.schenkelaars@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut and vaginal microbiota (time frame: Preconceptional (up to 1 year before pregnancy)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05754645, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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