UMIN-ICDS Clinical Trial

Public title

Pregnancy outcomes in patients with Familial Mediterranean Fever: a systematic review and meta-analysis

Acronym

Pregnancy outcomes in patients with Familial Mediterranean Fever: a systematic review and meta-analysis

Scientific Title

Pregnancy outcomes in patients with Familial Mediterranean Fever: a systematic review and meta-analysis

Scientific Title:Acronym

Pregnancy outcomes in patients with Familial Mediterranean Fever: a systematic review and meta-analysis

Region

Japan

Condition

Familial Mediterranean Fever (FMF)

Classification by specialty

Clinical immunology

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Familial Mediterranean fever (FMF) is characterized by recurrent episodes of fever and serositis. Recurrent attacks during pregnancy can eventually lead to miscarriage and premature delivery. Colchicine is the drug of choice for FMF and is used to prevent the onset and reduce the severity of FMF attacks and amyloidosis, but little is known about the perinatal prognosis for FMF patients. Therefore, we will conduct systematic review and meta-analysis to evaluate the pregnancy outcomes in FMF patients and to compare them with healthy controls.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome: The primary endpoints are miscarriage, premature delivery and fetal growth restriction. The odds ratio (OR) will be calculated. Meta-analysis will be performed to compare the incidence of co-primary outcomes between FMF patients and healthy controls.

Key secondary outcomes

The secondary outcomes are hypertensive disorders, caesarean delivery and fetal anomaly.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

(1) The published study including case-control study, cohort study, and randomized clinical trial.
(2) The experimental group of the study was FMF with healthy control.
(3) The patients were clinically diagnosed with FMF.
(5) The study illustrated the pregnancy outcomes of FMF.

Key exclusion criteria

(1) Systematic review or meta-analysis articles.
(2) Case reports or case series reporting less than 5 cases.
(3) The republished research literature is excluded unless the research includes new findings related to pregnancy outcomes.
(4) Studies published in languages other than English.

Target sample size

Name of lead principal investigator

1st name	Kaoru
Middle name
Last name	Minegishi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Stem Cell and Immune Regulation

Zip code

236-0004

Address

3-9, Kanazawa, Fukuura, Yokohama

TEL

045-787-2630

Email

kaoru_t@yokohama-cu.ac.jp

Name of contact person

1st name	Kaoru
Middle name
Last name	Minegishi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Stem Cell and Immune Regulation

Zip code

236-0004

Address

3-9, Kanazawa, Fukuura, Yokohama

TEL

045-787-2630

Homepage URL

Email

kaoru_t@yokohama-cu.ac.jp

Institute

Yokohama City University Graduate School of Medicine

Institute

Department

Personal name

Organization

Yokohama City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University Graduate School of Medicine

Address

3-9, Kanazawa, Fukuura, Yokohama

Tel

045-787-2630

Email

kaoru_t@yokohama-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

12

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

854

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

Recruitment status

Completed

Date of protocol fixation

2022

Year

12

Month

19

Day

Date of IRB

2022

Year

12

Month

19

Day

Anticipated trial start date

2022

Year

12

Month

19

Day

Last follow-up date

2023

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in December 2022. A hand search will be conducted by two investigators.


Participants: The patients were clinically diagnosed with FMF.
Intervention: No intervention.
Comparison: Healthy control.
Outcome: Incidence of adverse pregnancy outcomes.

Two investigators independently will screen all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.

The risk of bias of each study will be assessed by the Newcastle-Ottawa Scale for cohort studies.

Subgroup analysis:
Subgroup analysis based on colchicine use will be performed for the primary and secondary outcomes.

Registered date

2022

Year

12

Month

19

Day

Last modified on

2023

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056751