Skip to content

Vaginal microbiome in late pregnancy and parturition

Changes in vaginal microbiome and metabolome in late pregnancy and parturition among women with spontaneous or induced vaginal delivery and before elective cesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN29892347
Enrollment
600
Registered
2018-09-18
Start date
2017-05-01
Completion date
Unknown
Last updated
2023-02-13

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

Conditions

Pregnancy, spontaneous or induced vaginal delivery and elective cesarean section Pregnancy and Childbirth

Interventions

Current interventions as of 20/09/2019: The aim is to recruit altogether 600 patients in the following three groups: 1. 200 late and post term gravidae (41+0 or more we

Sponsors

Helsinki University Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria 20/09/2019: 1. Female 2. Age 18 or older Further inclusion criteria for different study arms: Post-term induction study arm: 1. Patients have more than 41+0 pregnancy weeks 2. Intact membranes before the induction of labor Early-term and full-term parturition study arm: 1. Patients come to the delivery ward with contractions and intact membranes 2. Patients have 37+0-40+6 pregnancy weeks Cesarean section study arm: 1. Patients are scheduled for an elective cesarean section 2. Patients have 37+0-40+6 pregnancy weeks on the scheduled cesarean section date Previous participant inclusion criteria: 1. Female 2. Age 18 to 45 Further inclusion criteria for different study arms: Post-term induction study arm: 1. Patients have more than 41+0 pregnancy weeks 2. Intact membranes before the induction of labor Early-term and full-term parturition study arm: 1. Patients come to the delivery ward with contractions and intact membranes 2. Patients have 37+0-40+6 pregnancy weeks Cesarean section study arm: 1. Patients are scheduled for an elective cesarean section 2. Patients have 37+0-40+6 pregnancy weeks on the scheduled cesarean section date

Exclusion criteria

Exclusion criteria: 1. Breech presentation in vaginal delivery 2. Non-singleton pregnancy

Design outcomes

Primary

MeasureTime frame
Vaginal microbiome composition assessed using Illumina Miseq or HiSeq technology targeting the V3-V4 region of 16S rRNA gene All of the outcomes are measured at baseline. In the post term induction study group and early and full term study group the outcomes are also measured during the induction and parturition.

Secondary

MeasureTime frame
1. Vaginal cytokine profile measured using multiplex ELISA and/or Luminex 2. Vaginal proteomic profile measured using tandem mass spectrometry 3. Bacterial metabolites analyzed with NMR spectroscopy All of the outcomes are measured at baseline. In the post term induction study group and early and full term study group the outcomes are also measured during the induction and parturition.

Countries

Finland

Contacts

Public ContactKaisa Kervinen

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026