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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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