UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029242