The promote study, a pilot: The characterization of the microbiome in pregnancy and prediction of pregnancy outcomes.

The promote study, a pilot: The characterization of the microbiome in pregnancy and prediction of pregnancy outcomes. - PROMOTE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51666

Enrollment

240

Registered

2022-07-04

Start date

2022-07-21

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Darmdysbiose: ongunstige verstoring van het microbioom van de darmen. ongunstige samenstelling van darmmicroben. zwangerschapssuikerziekte Zwangerschapsvergiftiging

Interventions

None listed

Eligibility

Age

No minimum to 64 Years

Inclusion criteria

Inclusion criteria: • Participation in Predict study • Preconceptional women who wish to become pregnant or pregnancy 30 kg/m2 or 18-25 kg/m2 • Understanding of Dutch in speaking and reading • Willingness to give written informed consent For participants included for maternal fecal collection only the following criteria apply: • BMI > 30 kg/m2 or 18,5-25 kg/m2 • > 28 weeks of gestational age • Understanding of Dutch in speaking and reading • Willingness to give written informed consent

Exclusion criteria

Exclusion criteria: • Age 45 years. • >=13 weeks of gestational age • Multiple pregnancy • Smoking • Gastro-intestinal diseases, heart diseases, liver, pancreas and kidney diseases. • Use of antibiotics 45 years. •

Design outcomes

Primary

Measure	Time frame
The composition of the maternal gut and vaginal microbiome (in obese women (BMI >30 kg/m2) and non-obese women (BMI 18-25 kg/m2)).	—

Secondary

Measure	Time frame
The associations between the composition of the microbiome and: 1) Clinical maternal outcomes (e.g. pregnancy outcome, gestational age at delivery, preeclampsia, hypertension, gestational diabetes) 2) Clinical fetal outcomes (e.g. fetal growth trajectories in first, second and third trimester, birthweight) 3) Maternal (and fetal) immune response and one-carbon metabolism (e.g. inflammatory and biomarkers) 4) Placental function (e.g. placental vascular architecture and volume during the 1st trimester, placental weight, inflammatory status)	—

Measure

Time frame

The associations between the composition of the microbiome and: 1) Clinical maternal outcomes (e.g. pregnancy outcome, gestational age at delivery, preeclampsia, hypertension, gestational diabetes) 2) Clinical fetal outcomes (e.g. fetal growth trajectories in first, second and third trimester, birthweight) 3) Maternal (and fetal) immune response and one-carbon metabolism (e.g. inflammatory and biomarkers) 4) Placental function (e.g. placental vascular architecture and volume during the 1st trimester, placental weight, inflammatory status)

—

Countries

Netherlands

Outcome results