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 2020/08/10 00:24:34

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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
Middle name
Last name Hiroko Hirano

Organization

Shizuoka General Hospital

Division name

Department of Nephrology

Zip code


Address

4-27-1 Kita-Ando, Aoi-ku, Shizuoka, Japan

TEL

054-247-6111

Email

hiranohiroko1130@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hiroko Hirano

Organization

Shizuoka General Hospital

Division name

Department of Nephrology

Zip code


Address

4-27-1 Kita-Ando, Aoi-ku, Shizuoka, Japan

TEL

054-247-6111

Homepage URL


Email

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


Address


Tel


Email



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

No longer recruiting

Date of protocol fixation

2017 Year 03 Month 22 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 01 Day

Last follow-up date


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

2020 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036860


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name