Preterm BirthNCT04165252
Vaginal, Placental and Neonatal Buccal Mycobiota and Microbiome in Preterm Birth
An observational study of Preterm Birth and Microbial Colonization, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Microbial Colonization
- What is being tested?
- Collection of vaginal, neonatal buccal and placental samples
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 1 Dec 2022
- How long will I take part?
- 41 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women attending prenatal clinics of Koc University Hospital in Istanbul.
Who may be able to join
- Singleton pregnancies
- The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained
Who cannot join
- Multiple pregnancies
- The presence of a major fetal anomaly or known chromosomal abnormality
- Finding the intrauterine mort de fetus
- Antibiotic and/or antifungal use within two weeks at the collection of samples
- Pregnant women under 18 years of age
- Women with previous cervical surgery
Show all 9Show fewer
- Women who do not accept to participate to be in the study
- The presence of a uterine anomaly
- Women with vaginal bleeding at the time of cervical swabs taken
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koc University Hospital
Istanbul, 34010
Ebru Celik, M.D., +905326035151, ecelik@ku.edu.tr
Mert Turgal, M.D., mturgal@kuh.ku.edu.tr
About this study
Official title: Evaluation of the Relationship Between Vaginal, Placental and Neonatal Mycobiota and Microbiome With Preterm Birth in Women With Short Cervical Length
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).
Read more
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.
Read the detailed description
Preterm birth is responsible for more than 70% of all neonatal and infant deaths. In addition, the risk of cerebral palsy among children born preterm is 10 times than those born at term. The risk of preterm birth is inversely related to cervical length at midgestation. Randomized-controlled trials involving singleton pregnancies with a short cervical length ( less than 25 mm) have shown that the prophylactic use of progesterone significantly decrease the rate of preterm delivery and neonatal death. The relation of vaginal micobiota with preterm birth has been documented. Yet, impact of short cervical lenght and progesteron treatment on vaginal, neonatal and placental microbiota and mycobiota has not been evaluated. The objectives of present study are to adress the following points;
- Longitudinal maternal (vaginal), fetal (oral) and placental (basal plate and parenchyma) 16S-based and 18S-based metagenomic profiling with inferred metagenomics will reveal distinct microbial communities in association with preterm birth.
- Comparison of vaginal, neonatal (buccal) and placental (basal plate and parenchyma) 16s rRNA with bacteria and 18s rRNA with fungi in pregnant women with a short cervical length with those with normal cervical length;
- Comparison of maternal (vaginal), neonatal(oral) and placental (basal plate and parenchyma)16s rRNA with bacteria and 18s rRNA with fungi in pregnant women with short cervical length who gave a preterm birth with those who gave birth at term; 3. The effect of progesterone on maternal (vaginal), neonatal (buccal) and placental (basal plate and parenchyma)16s rRNA with bacteria and 18s rRNA with fungi.
The measurements of cervical length will be performed in two different periods of pregnancy (11-14 and 18-22 weeks of gestation) in singleton pregnancies. Firstly, the vaginal swabs will be collected from women who accept to participate in the study at 11-14th weeks of gestation just before the measurement of cervical length. Also, the vaginal swabs will be done again at 18-22 weeks of gestation as explained above. Micronized progesterone will be started in women with a cervical length equal or less than 25 mm (smaller than 3rd percentile) at 18-22 weeks of gestation. The medication (progesterone 200mg) will be administered intravaginally every night before bedtime and will continue until 36th gestational week unless the patient gives birth. Measurement of cervical length will be repeated transvaginally at 28th and 32nd gestational weeks, and samples will be obtained with a cervical swab before these measurements. In order to evaluate the presence of placental mycobiota and microbiota, 1 cm x 1 cm x 1 cm of the tissue sample from the placenta that is 3 cm lateral of the cord insertion will be taken under sterile conditions after birth. In order to evaluate the amniotic compartment, a buccal mucosal swab will be collected from the neonates immediately after birth. All samples will be delivered to our Research Laboratory immediately and stored in -80 ℃ cabinet until the evaluation. The V3-V4 regions by the 16s ribosomal RNA sequencing method will be sequenced with the Illumina MiSeq device and the data will be analyzed according to the protocols standardized in the Human Microbiome Project.
DNA samples that will be ranked from the data to be sequenced in accordance with the ITS1 region metabiota protocol will be evaluated within the Human Microbiome Project.
Pseudomonas, Escherichia, Neisseria, Streptococcus, Lactobacillus, Candida, Actinomyces will be used as positive controls and, V3-V4 and ITS regions will be matched for bacterial microbiota and Fungal microbiota. After the "Operational taxonomic units" of the amplicons are configured with the VSEARCH program, the analyzes will be carried out with GENBANK microbiota and micobiota data.
- Conditions
- Preterm Birth, Microbial Colonization
- Being tested
- Collection of vaginal, neonatal buccal and placental samples
- Keywords
- Preterm birth, Microbiota, Mycobiota, Short Cervix, Progesterone
- Medical subject headings
- Premature Birth, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of vaginal, neonatal buccal and placental samplesDiagnostic test
Analysis of microbiome and mycobiota of vaginal, neonatal buccal and placental
| Study group | Role | What they receive |
|---|---|---|
| Term Birth | Delivery between 37-41 weeks of gestation Receives: Diagnostic Test: Collection of vaginal, neonatal buccal and placental samples | |
| Preterm birth | Delivery between 24-37 weeks of gestation Receives: Diagnostic Test: Collection of vaginal, neonatal buccal and placental samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of Maternal-Fetal microbiome and mycobiome
Characterize the maternal(vaginal), placental, and neonatal (buccal) microbiome and mycobiome in a cohort at risk of preterm birth by using the BIO Power Soil DNA Isolation kit. The investigators will able to evaluate whether there is an association between microbiome and mycobiome changes with preterm birth. The V3-V4 regions by the 16s rRNA and ITS regions by 18s rRNA sequencing method will be sequenced. After the "Operational taxonomic units" of the amplicons are configured with the VSEARCH program, the analyzes will be carried out with GENBANK microbiota and micobiota data.
Measured: 11 weeks of gestation to date of delivery
Secondary outcomes (2)
The effect of progesterone on maternal microbiome (vaginal and placenta) with progesterone
Characterize the maternal, placental, and neonatal microbiome in a cohort at risk of preterm birth who receive progesterone treatment. Not all the women will ultimately deliver at term despite of prophylactic management of progesterone; the investigators will be able to see if there are microbiome changes associated with preterm birth by using the BIO Power Soil DNA Isolation kit. We will able to evaluate whether there is an association between microbiome and mycobiome changes with preterm birth. The V3-V4 regions by the 16s rRNA and ITS regions by 18s rRNA sequencing method will be sequenced. After the "Operational taxonomic units" of the amplicons are configured with the VSEARCH program, the analyzes will be carried out with GENBANK microbiota and micobiota data.
Measured: 11 weeks of gestation to date of delivery
Variety of microbial and mycobial fingerprintings
Comparison of vaginal, neonatal buccal and placental 16S rRNA and 18S rRNA gene sequencing between women with a short cervix who give a preterm birth with those who deliver at term.
Measured: 11 weeks of gestation to date of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Apr 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
- Target duration
- 41 Weeks
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Ebru Celik, M.D., Study director, Koç UniversityFusun Can, M.D., Study director, Koc University School of MedicineMert Turgal, M.D., Principal investigator, Koc University School of MedicineOzlem Dogan, M.D., Principal investigator, Koc University School of MedicineMehmet Gonen, P.h.D, Principal investigator, Koc University School of MedicineTugba Gursoy, M.D., Principal investigator, Koc University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165252
- Sponsor's protocol ID
- 119S463
- Status last verified
- Mar 2021
- First submitted
- 14 Oct 2019
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The recruitment of participants will begin on November 2019 and the anticipated date for the completion of the study is November 2022.
Publications
Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med. 2014 May 21;6(237):237ra65. doi: 10.1126/scitranslmed.3008599.
PubMed 24848255DiGiulio DB, Romero R, Amogan HP, Kusanovic JP, Bik EM, Gotsch F, Kim CJ, Erez O, Edwin S, Relman DA. Microbial prevalence, diversity and abundance in amniotic fluid during preterm labor: a molecular and culture-based investigation. PLoS One. 2008 Aug 26;3(8):e3056. doi: 10.1371/journal.pone.0003056.
PubMed 18725970Gardella C, Riley DE, Hitti J, Agnew K, Krieger JN, Eschenbach D. Identification and sequencing of bacterial rDNAs in culture-negative amniotic fluid from women in premature labor. Am J Perinatol. 2004 Aug;21(6):319-23. doi: 10.1055/s-2004-831884.
PubMed 15311367Han YW, Shen T, Chung P, Buhimschi IA, Buhimschi CS. Uncultivated bacteria as etiologic agents of intra-amniotic inflammation leading to preterm birth. J Clin Microbiol. 2009 Jan;47(1):38-47. doi: 10.1128/JCM.01206-08. Epub 2008 Oct 29.
PubMed 18971361Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.
PubMed 8569824Kindinger LM, Bennett PR, Lee YS, Marchesi JR, Smith A, Cacciatore S, Holmes E, Nicholson JK, Teoh TG, MacIntyre DA. The interaction between vaginal microbiota, cervical length, and vaginal progesterone treatment for preterm birth risk. Microbiome. 2017 Jan 19;5(1):6. doi: 10.1186/s40168-016-0223-9.
PubMed 28103952Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; McIntosh J, Feltovich H, Berghella V, Manuck T. The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. Am J Obstet Gynecol. 2016 Sep;215(3):B2-7. doi: 10.1016/j.ajog.2016.04.027. Epub 2016 Apr 28.
PubMed 27133011American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711.
PubMed 27661654Romero R, Nicolaides KH, Conde-Agudelo A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Hassan SS. Vaginal progesterone decreases preterm birth </= 34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta-analysis including data from the OPPTIMUM study. Ultrasound Obstet Gynecol. 2016 Sep;48(3):308-17. doi: 10.1002/uog.15953. Epub 2016 Jul 19.
PubMed 27444208DiGiulio DB, Romero R, Kusanovic JP, Gomez R, Kim CJ, Seok KS, Gotsch F, Mazaki-Tovi S, Vaisbuch E, Sanders K, Bik EM, Chaiworapongsa T, Oyarzun E, Relman DA. Prevalence and diversity of microbes in the amniotic fluid, the fetal inflammatory response, and pregnancy outcome in women with preterm pre-labor rupture of membranes. Am J Reprod Immunol. 2010 Jul 1;64(1):38-57. doi: 10.1111/j.1600-0897.2010.00830.x. Epub 2010 Mar 21.
PubMed 20331587
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Vaginal, Placental and Neonatal Mycobiota and Microbiome With Preterm Birth in Women With Short Cervical Length
- ClinicalTrials.gov ID
- NCT04165252
- Acronym / sponsor ID
- 119S463
- Conditions
- Preterm Birth, Microbial Colonization
- Keywords
- Preterm birth, Microbiota, Mycobiota, Short Cervix, Progesterone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preterm birth is responsible for more than 70% of all neonatal and infant deaths. In addition, the risk of cerebral palsy among children born preterm is 10 times than those born at term. The risk of preterm birth is inversely related to cervical length at midgestation. Randomized-controlled trials involving singleton pregnancies with a short cervical length ( less than 25 mm) have shown that the prophylactic use of progesterone significantly decrease the rate of preterm delivery and neonatal death. The relation of vaginal micobiota with preterm birth has been documented. Yet, impact of short cervical lenght and progesteron treatment on vaginal, neonatal and placental microbiota and mycobiota has not been evaluated. The objectives of present study are to adress the following points;
- Longitudinal maternal (vaginal), fetal (oral) and placental (basal plate and parenchyma) 16S-based and 18S-based metagenomic profiling with inferred metagenomics will reveal distinct microbial communities in association with preterm birth.
- Comparison of vaginal, neonatal (buccal) and placental (basal plate and parenchyma) 16s rRNA with bacteria and 18s rRNA with fungi in pregnant women with a short cervical length with those with normal cervical length;
- Comparison of maternal (vaginal), neonatal(oral) and placental (basal plate and parenchyma)16s rRNA with bacteria and 18s rRNA with fungi in pregnant women with short cervical length who gave a preterm birth with those who gave birth at term; 3. The effect of progesterone on maternal (vaginal), neonatal (buccal) and placental (basal plate and parenchyma)16s rRNA with bacteria and 18s rRNA with fungi.
The measurements of cervical length will be performed in two different periods of pregnancy (11-14 and 18-22 weeks of gestation) in singleton pregnancies. Firstly, the vaginal swabs will be collected from women who accept to participate in the study at 11-14th weeks of gestation just before the measurement of cervical length. Also, the vaginal swabs will be done again at 18-22 weeks of gestation as explained above. Micronized progesterone will be started in women with a cervical length equal or less than 25 mm (smaller than 3rd percentile) at 18-22 weeks of gestation. The medication (progesterone 200mg) will be administered intravaginally every night before bedtime and will continue until 36th gestational week unless the patient gives birth. Measurement of cervical length will be repeated transvaginally at 28th and 32nd gestational weeks, and samples will be obtained with a cervical swab before these measurements. In order to evaluate the presence of placental mycobiota and microbiota, 1 cm x 1 cm x 1 cm of the tissue sample from the placenta that is 3 cm lateral of the cord insertion will be taken under sterile conditions after birth. In order to evaluate the amniotic compartment, a buccal mucosal swab will be collected from the neonates immediately after birth. All samples will be delivered to our Research Laboratory immediately and stored in -80 ℃ cabinet until the evaluation. The V3-V4 regions by the 16s ribosomal RNA sequencing method will be sequenced with the Illumina MiSeq device and the data will be analyzed according to the protocols standardized in the Human Microbiome Project.
DNA samples that will be ranked from the data to be sequenced in accordance with the ITS1 region metabiota protocol will be evaluated within the Human Microbiome Project.
Pseudomonas, Escherichia, Neisseria, Streptococcus, Lactobacillus, Candida, Actinomyces will be used as positive controls and, V3-V4 and ITS regions will be matched for bacterial microbiota and Fungal microbiota. After the "Operational taxonomic units" of the amplicons are configured with the VSEARCH program, the analyzes will be carried out with GENBANK microbiota and micobiota data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 41 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Term Birth | – | Diagnostic Test: Collection of vaginal, neonatal buccal and placental samplesDelivery between 37-41 weeks of gestation |
| Preterm birth | – | Diagnostic Test: Collection of vaginal, neonatal buccal and placental samplesDelivery between 24-37 weeks of gestation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women attending prenatal clinics of Koc University Hospital in Istanbul.
Key inclusion criteria (2 listed)
- Singleton pregnancies
- The subject has voluntarily signed the Informed Consent Form and associated forms after having the contents explained
Key exclusion criteria (9 listed)
- Multiple pregnancies
- The presence of a major fetal anomaly or known chromosomal abnormality
- Finding the intrauterine mort de fetus
- Antibiotic and/or antifungal use within two weeks at the collection of samples
- Pregnant women under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of vaginal, neonatal buccal and placental samplesAnalysis of microbiome and mycobiota of vaginal, neonatal buccal and placental | Diagnostic test | Preterm birth, Term Birth |
Primary outcome
Characterization of Maternal-Fetal microbiome and mycobiome
Time frame: 11 weeks of gestation to date of delivery
Characterize the maternal(vaginal), placental, and neonatal (buccal) microbiome and mycobiome in a cohort at risk of preterm birth by using the BIO Power Soil DNA Isolation kit. The investigators will able to evaluate whether there is an association between microbiome and mycobiome changes with preterm birth. The V3-V4 regions by the 16s rRNA and ITS regions by 18s rRNA sequencing method will be sequenced. After the "Operational taxonomic units" of the amplicons are configured with the VSEARCH program, the analyzes will be carried out with GENBANK microbiota and micobiota data.
2 secondary outcomes
The effect of progesterone on maternal microbiome (vaginal and placenta) with progesterone
Time frame: 11 weeks of gestation to date of delivery
Variety of microbial and mycobial fingerprintings
Time frame: 11 weeks of gestation to date of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Background: PubMed 24848255Aagaard K, Ma J, Antony KM, Ganu R, Petrosino J, Versalovic J. The placenta harbors a unique microbiome. Sci Transl Med. 2014 May 21;6(237):237ra65. doi: 10.1126/scitranslmed.3008599.
- Background: PubMed 18725970DiGiulio DB, Romero R, Amogan HP, Kusanovic JP, Bik EM, Gotsch F, Kim CJ, Erez O, Edwin S, Relman DA. Microbial prevalence, diversity and abundance in amniotic fluid during preterm labor: a molecular and culture-based investigation. PLoS One. 2008 Aug 26;3(8):e3056. doi: 10.1371/journal.pone.0003056.
- Background: PubMed 15311367Gardella C, Riley DE, Hitti J, Agnew K, Krieger JN, Eschenbach D. Identification and sequencing of bacterial rDNAs in culture-negative amniotic fluid from women in premature labor. Am J Perinatol. 2004 Aug;21(6):319-23. doi: 10.1055/s-2004-831884.
- Background: PubMed 18971361Han YW, Shen T, Chung P, Buhimschi IA, Buhimschi CS. Uncultivated bacteria as etiologic agents of intra-amniotic inflammation leading to preterm birth. J Clin Microbiol. 2009 Jan;47(1):38-47. doi: 10.1128/JCM.01206-08. Epub 2008 Oct 29.
- Background: PubMed 8569824Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. doi: 10.1056/NEJM199602293340904.
- Background: PubMed 28103952Kindinger LM, Bennett PR, Lee YS, Marchesi JR, Smith A, Cacciatore S, Holmes E, Nicholson JK, Teoh TG, MacIntyre DA. The interaction between vaginal microbiota, cervical length, and vaginal progesterone treatment for preterm birth risk. Microbiome. 2017 Jan 19;5(1):6. doi: 10.1186/s40168-016-0223-9.
- Background: PubMed 27133011Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; McIntosh J, Feltovich H, Berghella V, Manuck T. The role of routine cervical length screening in selected high- and low-risk women for preterm birth prevention. Am J Obstet Gynecol. 2016 Sep;215(3):B2-7. doi: 10.1016/j.ajog.2016.04.027. Epub 2016 Apr 28.
- Background: PubMed 27661654American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. Practice Bulletin No. 171: Management of Preterm Labor. Obstet Gynecol. 2016 Oct;128(4):e155-64. doi: 10.1097/AOG.0000000000001711.
- Background: PubMed 27444208Romero R, Nicolaides KH, Conde-Agudelo A, O'Brien JM, Cetingoz E, Da Fonseca E, Creasy GW, Hassan SS. Vaginal progesterone decreases preterm birth </= 34 weeks of gestation in women with a singleton pregnancy and a short cervix: an updated meta-analysis including data from the OPPTIMUM study. Ultrasound Obstet Gynecol. 2016 Sep;48(3):308-17. doi: 10.1002/uog.15953. Epub 2016 Jul 19.
- Results publication: PubMed 20331587DiGiulio DB, Romero R, Kusanovic JP, Gomez R, Kim CJ, Seok KS, Gotsch F, Mazaki-Tovi S, Vaisbuch E, Sanders K, Bik EM, Chaiworapongsa T, Oyarzun E, Relman DA. Prevalence and diversity of microbes in the amniotic fluid, the fetal inflammatory response, and pregnancy outcome in women with preterm pre-labor rupture of membranes. Am J Reprod Immunol. 2010 Jul 1;64(1):38-57. doi: 10.1111/j.1600-0897.2010.00830.x. Epub 2010 Mar 21.
- Individual participant dataSharing planned: Yes. The recruitment of participants will begin on November 2019 and the anticipated date for the completion of the study is November 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Celik, M.D. study director
Koç University
Fusun Can, M.D. study director
Koc University School of Medicine
Mert Turgal, M.D. principal investigator
Koc University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Microbial Colonization, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebru Celik, M.D. (+90 850 250 8 250 ext. 21654, ecelik@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of Maternal-Fetal microbiome and mycobiome (time frame: 11 weeks of gestation to date of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04165252, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.