NCT04165252

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

Status unknown Last updated 2 June 2021

What this trial tests

trial testing Collection of vaginal, neonatal buccal and placental samples in Preterm Birth in 92 participants. Status unknown.

Timeline

1 April 2020

Primary endpoint
1 December 2021

1 December 2022

Quick facts

Lead sponsor	Koç University
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	92
Start date	1 April 2020
Primary completion	1 December 2021
Estimated completion	1 December 2022
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Collection of vaginal, neonatal buccal and placental samples

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →
• Microbial Colonization — all drugs for Microbial Colonization →

Sponsor

Koç University

Who can join

Adults 18 to 45, female only, with Preterm Birth or Microbial Colonization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alterations in vaginal microbiota among pregnant women with COVID-19.
   Celik E, Ozcan G, Vatansever C, Paerhati E, et al · · 2023 · cited 6× · PMID 36068653 · DOI 10.1002/jmv.28132
2. Alterations in vaginal microbiome in women with short cervix: longitudinal study of microbial diversity and impact of vaginal progesterone treatment.
   Celik E, Ozcan G, Vatansever C, Paerhati E, et al · · 2025 · cited 1× · PMID 40569025 · DOI 10.1002/uog.29269
3. Alterations in Vaginal Microbiota among Pregnant Women with COVID-19
   Celik E, Ozcan G, Vatansever C, Paerhati E, et al · · 2021 · cited 1× · DOI 10.21203/rs.3.rs-1068822/v1