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
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
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
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
