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Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

NCT ID: NCT02304237

Last Updated: 2014-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-12-31

Brief Summary

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This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of progesterone therapy in prevention of preterm birth in high risk pregnant women.

Detailed Description

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The objectives of this study is 1) To compare the efficacy of two different regimens of progesterone therapy in preventing preterm birth less than 37 weeks of gestation. 2) To compare the cost-benefit, adverse effects and patient preference of two different regimens of progesterone therapy.

Design: Multi-center, randomized, open-label trial

Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Vaginal progesterone

Vaginal progesterone(Utrogestan)200mg/day, during 14\~21 weeks.

Group Type EXPERIMENTAL

Vaginal progesterone

Intervention Type DRUG

micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes

Intramuscular progesterone

Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14\~21 weeks.

Group Type ACTIVE_COMPARATOR

Intramuscular progesterone

Intervention Type DRUG

hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes

Interventions

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Vaginal progesterone

micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes

Intervention Type DRUG

Intramuscular progesterone

hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes

Intervention Type DRUG

Other Intervention Names

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Utrogestan Progesterone Depot Jenapharm Injection

Eligibility Criteria

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Inclusion Criteria

* With a history of prior spontaneous preterm birth or short cervix length
* Spontaneous preterm birth: preterm birth \<37 weeks of gestation due to spontaneous preterm labor or preterm premature rupture of membranes (PPROM)
* Short Cervix length : cervix length \<25 mm as measured by transvaginal ultrasound at 16-24 weeks of gestation

Exclusion Criteria

* Multiple gestations
* Major congenital anomalies
* Elective prophylactic cervical cerclage \<16 weeks of gestation during current pregnancy
* Previous intentional preterm birth due to maternal or fetal indications, such as preeclampsia and fetal growth restriction
* Diabetes, hypertension, other severe medical diseases
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role collaborator

Han Wha Pharma Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Ewha Womans University Mokdong Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Ju Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young Ju Kim

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Central Contacts

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Young Ju Kim

Role: CONTACT

[email protected]
822-2650-5500

SUK-JOO CHOI

Role: CONTACT

[email protected]
822-3410-3546

References

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Choi SJ, Kwak DW, Kil K, Kim SC, Kwon JY, Kim YH, Na S, Bae JG, Cha HH, Shim JY, Oh KY, Lee KA, Kim SM, Cho IA, Lee SM, Cho GJ, Jo YS, Choi GY, Choi SK, Hur SE, Hwang HS, Kim YJ; from The Preterm Birth Research Committee of the Korean Society of Maternal Fetal Medicine. Vaginal compared with intramuscular progestogen for preventing preterm birth in high-risk pregnant women (VICTORIA study): a multicentre, open-label randomised trial and meta-analysis. BJOG. 2020 Dec;127(13):1646-1654. doi: 10.1111/1471-0528.16365. Epub 2020 Jul 14.

Reference Type DERIVED
PMID: 32536019 (View on PubMed)

Other Identifiers

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VICTORIA

Identifier Type: -

Identifier Source: org_study_id