UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025404
Receipt number R000029242
Scientific Title Cervical pessary for the prevention of preterm delivery.
Date of disclosure of the study information 2017/01/15
Last modified on 2021/03/14 15:19:42

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Basic information

Public title

Cervical pessary for the prevention of preterm delivery.

Acronym

Preterm LabOr preVEntion, Multicenter study fOr Maternal cervical pessary(LOVE MOM)

Scientific Title

Cervical pessary for the prevention of preterm delivery.

Scientific Title:Acronym

Preterm LabOr preVEntion, Multicenter study fOr Maternal cervical pessary(LOVE MOM)

Region

Japan


Condition

Condition

Preterm Delivery

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to identify the efficacy of cervical pessary in prevention of preterm delivery.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Delivery less than 34 weeks gestation.

Key secondary outcomes

A)Efficacy
Delivery less than 37weeks, Delivery less than 28weeks, Rupture of membrane less than 34 weeks
B)maternal background
age, pregnancy history, previous medical history, hight, body weight, smoking
C)Safty
Way of delivery, Bleeding at delivery, Cevical laceration, Uterus rupture, pessaty withdrawal, Chorioamnionitis, Vaginitis
D)Treatment for mother
Cervical length, corticosteroid treatment for fetal maturation
E)Background for baby
body weight, Gestational weeks at birth, Apgar score, Evaluation fo umbilical arterial blood gas
F)Safty for baby
Fetal death, Neonatal death, Adverse outcomes(Intraventricular hemorrhage, Respiratory distress syndrome, Retinopathy, Necrotising enterocolitis, Sepsis)
G)Treatment for baby
Respiratory treatment, Photo therapy, Antibiotics, Blood transfurion


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Cervical pessary from 20weeks to 36weeks gestation.

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

1)Pregnant women after 20 weeks gestation, who is disgnosed threatened miscarriage or threatened premature labor.
2)Cervical length of 25mm or less.
3)Women with informed consent for participation in this trial.

Key exclusion criteria

1)Women with multiple pregnant.
2)Majior fetal anomalies.
3)Painful regular uterine contractions.
4)Active vaginal bleeding.
5)Placenta previa.
6)Cervical myoma.
7)History of cone biopsy or cervical cerclage in situ.
8)Other pregnant women when study doctores conclude that they are not eligible for study enrollment.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yasuhiko
Middle name
Last name OZAKI

Organization

Nagoya City University Hostpital

Division name

Department of Obstetrics and Gynecology

Zip code

467-8602

Address

Kawasumi 1, Misuho-cho, Mizuho-ku, Nagoya, AICHI, JAPAN ZIP 467-8601

TEL

052-851-5511

Email

yozaki@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name Kyoko
Middle name
Last name KUMAGAI

Organization

Nagoya City University Hostpital

Division name

Department of Obstetrics and Gynecology

Zip code

467-8602

Address

Kawasumi 1, Misuho-cho, Mizuho-ku, Nagoya, AICHI, JAPAN ZIP 467-8601

TEL

052-851-5511

Homepage URL


Email

og-nzw@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Department of Obstetrics and Gynecology
Nagoya City University, Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical research management center, Nagoya city university hospital

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

Tel

052-858-7215

Email

clinical-research@med.nagoya-cu.ac.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

名古屋市立大学病院(愛知県)
名古屋市立西部医療センター(愛知県)
江南厚生病院(愛知県)
宮城県立こども病院(宮城県)
横浜市北部病院(神奈川県)
国立病院機構佐賀病院(佐賀県)


Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 15 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

237

Results

The results of this trial suggested that cervical pessary did not reduce preterm delivery, but may delay shortening of cervical length. Vaginal discharge was increased by using cervical pessary, no other adverse events were observed. There were no cases of intrauterine fetal demise in both groups. Cervical pessary may shorten duration of hospitalization and medication. In conclusion, cervical pessary may become one of a choice of prophylactic treatment for preterm delivery.

Results date posted

2021 Year 03 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Women with singleton pregnancy, 20+0 to 29+6 weeks gestation, 20 years and older were investigated. 237 were enrolled including 117 in pessary group and 120 in control group. Average age was 33.4 years for pessary group and 32.8 years for control group. Average pregnancy weeks at the registration was 25.6weeks.

Participant flow

Pregnant women: In pessary group, 117 women were investigated for safety analysis, 21 were excluded, therefore 96 women were investigated for efficacy analysis. Within 120 women, 34 were excluded, therefore 86 were investigated for safety and efficacy analysis in control group.
Neonate: There was no intrauterine demise in pessary group. 117 neonates were investigated for safety and efficacy analysis in pessary group. Neonate was excluded when mother was not applicable to analysis. 86 neonates were investigated for safety and efficacy analysis in control group.

Adverse events

none

Outcome measures

Primary Outcome: Delivery less than 34 weeks was 10(10.4%) in pessary group and 15(17.4%) in control group.
Secondary Outcomes: There were no statistical differences in delivery less than 37 weeks (pessary group vs control group; 24.0% vs 33.7%), delivery less than 28 weeks (2.1% vs 5.8%) and rupture of membrane less than 34 weeks (5.2% vs 5.8%).
Regression analysis showed that cervical length become shortened 0.65 mm/week during pregnancy. On the other hand, pessary might delay shortening of cervix by 0.43 mm/week.
Efficacy for pregnant women: Duration of hospitalization, use of ritodrine hydrochloride and magnesium sulfate hydrate were significantly reduced in pessary group.
Efficacy for neonates: Gestational age at birth and birthweight were significantly higher in pessary group.
Safety for pregnant women: Vaginal discharge was observed significantly higher in pessary group. No statistical difference was observed in chorioamnionitis, premature preterm rupture of membranes and vaginitis.
Safety for neonates: Hyperbilirubinemia was significantly lower in pessary group. There were no statistical differences in necrotizing enterocolitis, intraventricular hemorrhage, respiratory distress syndrome, retinopathy and sepsis between two groups.

Plan to share IPD

none

IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 12 Month 12 Day

Date of IRB

2019 Year 02 Month 20 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2020 Year 07 Month 31 Day

Date of closure to data entry

2020 Year 09 Month 21 Day

Date trial data considered complete

2021 Year 01 Month 13 Day

Date analysis concluded

2021 Year 01 Month 21 Day


Other

Other related information



Management information

Registered date

2016 Year 12 Month 26 Day

Last modified on

2021 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029242


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name