Vaginal, Placental and Neonatal Buccal Mycobiota and Microbiome in Preterm Birth

NCT04165252 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2021-06-02

No results posted yet for this study

Summary

Microbiota contributes to the immunological, hormonal and metabolic homeostasis of the host. As in all natural orifices in the body, there is also a microbiota and mycobiota specific to the vagina.

On the other hand, the sonographic short cervix in the second trimester of pregnancy is associated with preterm delivery, which may be an important cause of mortality and morbidity in the neonatal period. American Society of Obstetricians and Gynecologists (ACOG), British Royal Society of Obstetricians and Gynecologists (RCOG) and the American Society of Maternal Fetal Medicine (SMFM) suggest that the measurement of transvaginal sonographic cervical length at 20-24 gestational weeks for the screening of preterm birth. The aforementioned associations also recommend the use of progesterone in the treatment of women who diagnosed with short cervix by transvaginal ultrasonography due to the fact that progesterone is an effective medication in the prevention of preterm birth (Grade B).

Previous vaginal microbiota studies have shown that some bacterial species such as Lactobacillus insers cause a predisposition to premature labor in women with a short cervix. However, the prominent lack in these studies is that the eukaryotic fungi in abundant vaginal flora have not been evaluated.

On the other hand, it was already shown that progesterone treatment is able to prevent only 45% preterm birth in women with short cervical length. This observational prospective study thus aims to evaluate the variety of microbiota and/or mycobiota in pregnancies resulting in preterm birth and those who give birth at term. Although women with short cervical length receive progesterone regularly from the second trimester, the preterm birth may occur. In this study, the investigators also aim to evaluate the patterns of microbiota and mycobiota from vaginal swabs of women who had preterm birth with short cervical length and postpartum swabs of the placenta and fetal oral cavity.

Conditions

Interventions

DIAGNOSTIC_TEST

Collection of vaginal, neonatal buccal and placental samples

Analysis of microbiome and mycobiota of vaginal, neonatal buccal and placental

Sponsors & Collaborators

  • The Scientific and Technological Research Council of Turkey

    collaborator OTHER
  • Koç University

    lead OTHER

Principal Investigators

  • Ebru Celik, M.D. · Koç University

  • Fusun Can, M.D. · Koc University School of Medicine

  • Mert Turgal, M.D. · Koc University School of Medicine

  • Ozlem Dogan, M.D. · Koc University School of Medicine

  • Mehmet Gonen, P.h.D · Koc University School of Medicine

  • Tugba Gursoy, M.D. · Koc University School of Medicine

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-12-01
Completion
2022-12-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04165252 on ClinicalTrials.gov