UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052298 |
|---|---|
| Receipt number | R000059696 |
| Scientific Title | Prenatal exposure to intra-amniotic infection with Ureaplasma species increases the prevalence of bronchopulmonary dysplasia. |
| Date of disclosure of the study information | 2023/09/25 |
| Last modified on | 2023/09/25 12:31:14 |
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Basic information
Public title
Prenatal exposure to intra-amniotic infection with Ureaplasma species increases the prevalence of bronchopulmonary dysplasia.
Acronym
Prenatal exposure to intra-amniotic infection with Ureaplasma species increases the prevalence of bronchopulmonary dysplasia.
Scientific Title
Prenatal exposure to intra-amniotic infection with Ureaplasma species increases the prevalence of bronchopulmonary dysplasia.
Scientific Title:Acronym
Prenatal exposure to intra-amniotic infection with Ureaplasma species increases the prevalence of bronchopulmonary dysplasia.
Region
| Japan |
Condition
Condition
Intra-amniotic infection
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study investigated the relationship between bronchopulmonary dysplasia (BPD) and intra-amniotic infection with Ureaplasma species.
Basic objectives2
Others
Basic objectives -Others
The present study investigated the relationship between adverse neonatal outcomes and intra-amniotic infection with Ureaplasma species.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary study outcomes were the relationships between the prevalence of BPD and intra-amniotic infection with or without Ureaplasma spp. and intra-amniotic inflammation without MIAC after adjusting for gestational age at birth.
Key secondary outcomes
Secondary study outcomes were the relationships between the prevalence of adverse neonatal outcomes, and intra-amniotic infection with or without Ureaplasma spp. and intra-amniotic inflammation without MIAC after adjusting for potential confounders.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with singleton pregnancies (between August 2014 and April 2020) who underwent inpatient management at our department for PPROM, preterm labor, cervical insufficiency, and asymptomatic cervical shortening between 22 weeks 0 days and 33 weeks 6 days of gestation were included.
Key exclusion criteria
Exclusion criteria were as follows: delivery after 34 gestational weeks, fetal chromosomal abnormalities or multiple malformations, intrauterine fetal death, delivery at another hospital, MIAC in which Ureaplasma spp. and Mycoplasma hominis were not identified, and an unclear placental pathology or umbilical vein blood interleukin (IL)-6 concentration in patients in whom intra-amniotic inflammation or MIAC was not detected by amniocentesis or for whom amniocentesis was not indicated.
Target sample size
209
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Nomiyama |
Organization
National Hospital Organization, Saga National Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
849-8577
Address
Hinode 1-20-1, Saga, Japan
TEL
0952307141
nomiyama8522@gmail.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Nomiyama |
Organization
National Hospital Organization, Saga National Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
849-8577
Address
Hinode 1-20-1, Saga, Japan
TEL
0952307141
Homepage URL
nomiyama8522@gmail.com
Sponsor or person
Institute
National Hospital Organization, Saga National Hospital
Institute
Department
Personal name
Makoto Nomiyama
Funding Source
Organization
National Hospital Organization Saga National Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of the National Hospital Organization Saga National Hospital
Address
Hinode 1-20-1, Saga, Japan
Tel
0952307141
shouno.mitsuaki.np@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立病院機構佐賀病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
209
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
Intra-amniotic infection with Ureaplasma spp. was diagnosed in 37 patients, intra-amniotic infection without Ureaplasma spp. in 28, intra-amniotic inflammation without MIAC in 58, and preterm birth without MIR/FIR and FIRS in 86.After adjusting for potential confounders, a logistic regression analysis was performed to investigate the relationships between BPD, adverse neonatal outcomes, and intra-amniotic infection with and without Ureaplasma spp. and intra-amniotic inflammation without MIAC.
Management information
Registered date
| 2023 | Year | 09 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059696
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/09/25 | 5.後ろ向き研究計画書 - 性器マイコプラズマ子宮内感染 UMIN ICDR.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/09/25 | データ仕様書.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/09/25 | UMIN ICDR0925.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/59696
