UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032324 |
|---|---|
| Receipt number | R000036860 |
| Scientific Title | Pregnancy and delivery among women receiving dialysis: a nation-wide survey |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2024/12/05 09:32:28 |
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Basic information
Public title
Pregnancy and delivery among women receiving dialysis: a nation-wide survey
Acronym
Pregnancy and delivery among women receiving dialysis
Scientific Title
Pregnancy and delivery among women receiving dialysis: a nation-wide survey
Scientific Title:Acronym
Pregnancy and delivery among women receiving dialysis
Region
| Japan |
Condition
Condition
End stage renal disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to evaluate incidence of pregnancy and delivery among end stage renal disease women in reproductive ages who are receiving hemodialysis or peritoneal dialysis.
Basic objectives2
Others
Basic objectives -Others
Field survey is carried out and factors affecting clinical course of pregnancy and delivery of infants will be investigated.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of pregnancy among end stage renal disease patients at ages between 15 to 44, who were receiving dialysis therapy during a period between 2012/1/1 and 2016/12/31. Incidence of pregnancy will be determined by questionnaires collected from treating physicians in dialysis centers.
Key secondary outcomes
(1) Incidence of pregnancy among end stage renal disease patients at ages between 15 to 44, who were receiving dialysis therapy during a period between 2012/1/1 and 2016/12/31. It will be determined by questionnaires collected from eligible female patients.
(2) Incidence of live-born neonates (who survived more than for 28 days) delivered by end stage renal disease patients at ages between 15 to 44. Incidence of spontaneous abortion, elective abortion, stillborn baby and neonatal death are also studied.
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
| 15 | years-old | <= |
Age-upper limit
| 44 | years-old | >= |
Gender
Female
Key inclusion criteria
The present sturdy targets at end stage renal disease females, who were receiving hemodialysis therapy or peritoneal dialysis therapy in Japan.
(1) They should be in ages between 15 to 44 during a period between 2012/1/1 and 2016/12/31.
(2) They or their proxy should provide informed consent based upon their own free will.
Key exclusion criteria
(1) Patients who moved to other dialysis centers at reply of questionnaires are excluded.
(2) Patients who were no longer receiving dialysis therapy due to recovery of renal function or renal transplantation at reply of questionnaires are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Hirano |
Organization
Shizuoka General Hospital
Division name
Department of Nephrology
Zip code
4208527
Address
4-27-1 Kita-Ando, Aoi-ku, Shizuoka, Japan
TEL
054-247-6111
hiranohiroko1130@gmail.com
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Hirano |
Organization
Shizuoka General Hospital
Division name
Department of Nephrology
Zip code
4208527
Address
4-27-1 Kita-Ando, Aoi-ku, Shizuoka, Japan
TEL
054-247-6111
Homepage URL
hiranohiroko1130@gmail.com
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Trial Management
Address
4-27-1 Kita-Ando, Aoi-ku, Shizuoka, Japan
Tel
054-247-6111
no
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
静岡県立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | 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
1992
Results
Response was obtained from 951 dialysis units (35.3%). Among 1,992 target population in those dialysis units, 25 times of pregnancy (1.26%/5 years) were reported in 20 women. Detailed information about 19 pregnancies was collected in 15 women, outcomes were 4 spontaneous abortions, 1 elective abortion, 14 surviving infants, and no neonatal death. The live birth rate without elective abortion was 77.8%. Mean gestational age and birth weight were 33.7 weeks and 1853 g, respectively.
Results date posted
| 2020 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The target population was defined as women aged 15-44 years undergoing maintenance dialysis between 2012/1/1
and 2016/12/31.
Participant flow
A preliminary questionnaire was sent to 2,693 dialysis units, which took care of the whole target population in Japan (7,225 women in number). To collect nephrological, obstetric and neonatal information, a more detailed questionnaire was sent to dialysis units that responded.
Adverse events
Outcome measures
Incidence of pregnancy among end stage renal disease patients at ages between 15 to 44, who were receiving dialysis therapy during a period between 2012/1/1 and 2016/12/31.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcomes, secondary outcomes and factors affecting clinical course of pregnancy and delivery of infants will be investigated.
Management information
Registered date
| 2018 | Year | 04 | Month | 20 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036860
