NCT02304237

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2014

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 1, 2014

Status Verified

November 1, 2014

Enrollment Period

1.9 years

First QC Date

November 26, 2014

Last Update Submit

November 26, 2014

Conditions

Premature Birth

Keywords

Premature Birthprogesterone

Outcome Measures

Primary Outcomes (1)

  • Preterm Birth Rate before 37 weeks of gestation

    from study enrollment to maximum 37 weeks of gestation

Secondary Outcomes (4)

  • Preterm Birth Rate before 34 weeks of gestation

    from study enrollment to maximum 34 weeks of gestation

  • Preterm Birth Rate before 28 weeks of gestation

    from study enrollment to maximum 28 weeks of gestation

  • Result of birth(rate of death, weight, cause of hospitalization to NICU)

    from study enrollment to maximum 37 weeks of gestation

  • Any complications occurred to newborn and mother

    from study enrollment to maximum 37 weeks of gestation

Study Arms (2)

Vaginal progesterone

EXPERIMENTAL

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

Drug: Vaginal progesterone

Intramuscular progesterone

ACTIVE COMPARATOR

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

Drug: Intramuscular progesterone

Interventions

Vaginal progesteroneDRUG

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

Also known as: Utrogestan
Vaginal progesterone
Intramuscular progesteroneDRUG

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

Also known as: Progesterone Depot Jenapharm Injection
Intramuscular progesterone

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32536019DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Utrogestan

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Young Ju Kim

    Ewha Womans University Mokdong Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Ju Kim

CONTACT

822-2650-5500kkyj@ewha.ac.kr

SUK-JOO CHOI

CONTACT

822-3410-3546drmaxmix.choi@samsung.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 1, 2014

Study Start

December 1, 2014

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

December 1, 2014

Record last verified: 2014-11