Vaginal, Placental and Neonatal Buccal Mycobiota and Microbiome in Preterm Birth
NCT04165252 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 92
Last updated 2021-06-02
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
- Preterm Birth
- Microbial Colonization
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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