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Assessment of vaginal microbiota among pregnant women using vaginal progesterone to prevent preterm birth.

Assessment of vaginal lactobacilli species and common vaginal infections among pregnant women using vaginal progesterone to prevent preterm birth. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/086945
Enrollment
60
Registered
2025-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: O092- Supervision of pregnancy with other poor reproductive or obstetric history

Interventions

Intervention1: Nil: Nil

Sponsors

PGIMER, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Cases- Pregnant women between 20-24 weeks of gestation currently using a vaginal progesterone preparation (and have been using it for at least 4 weeks) for prevention of preterm birth due to prior spontaneous preterm birth or premature prelabour rupture of membranes. Controls- Healthy pregnant women between 20-24 weeks of gestation which include those women who are not using any vaginal progesterone preparation and have no history of prior preterm birth or preterm prelabour rupture of membranes.

Exclusion criteria

Exclusion criteria: 1.Women with cervical encerclage in situ 2.Multifetal pregnancy 3.Active infections like tuberculosis, HIV, genital herpes 4.Fetal malformations 5.Severe hypertension, uncontrolled diabetes, severe anemia, heart disease, autoimmune disorders or any other medical disorder 6.Antepartum haemorrhage

Design outcomes

Primary

MeasureTime frame
To assess the vaginal lactobacilli species among pregnant women using vaginal progesterone for prevention of preterm birth and compare it with healthy pregnant women.Timepoint: 1.5 years

Secondary

MeasureTime frame
To compare the prevalence of vaginal infections (bacterial vaginosis, candidiasis and trichomonal vaginitis) among the above two groups of women.Timepoint: 1.5 years;To compare the chlamydial and gonococcal infections (assessed by urine PCR) among the two groups of women.Timepoint: 1.5 years;To see the various pregnancy outcomes (PTB) in the above two groups of women.Timepoint: 1.5 years

Countries

India

Contacts

Public ContactDr Rashmi Bagga

Postgraduate Institute of Medical Education and Research, Chandigarh

rashmibagga@gmail.com9872494602

Outcome results

None listed

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