Premature BirthPhase 3NCT02304237
Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
A Phase 3 study testing Vaginal progesterone and Intramuscular progesterone in people with Premature Birth, run by Ewha Womans University Mokdong Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Premature Birth
- What is being tested?
- Vaginal progesterone and Intramuscular progesterone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Randomized, Open-label, Investigator Initiated Trial of Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
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.
Read the detailed description
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
- Premature Birth
- Being tested
- Vaginal progesterone, Intramuscular progesterone
- Keywords
- Premature Birth, progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal progesteroneDrug
Also called Utrogestan
micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes
Intramuscular progesteroneDrug
Also called Progesterone Depot Jenapharm Injection
hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone | Experimental | Vaginal progesterone(Utrogestan)200mg/day, during 14~21 weeks. Receives: Drug: Vaginal progesterone |
| Intramuscular progesterone | Active comparator | Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14~21 weeks. Receives: Drug: Intramuscular progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Birth Rate before 37 weeks of gestation
Measured: from study enrollment to maximum 37 weeks of gestation
Secondary outcomes (4)
Preterm Birth Rate before 34 weeks of gestation
Measured: from study enrollment to maximum 34 weeks of gestation
Preterm Birth Rate before 28 weeks of gestation
Measured: from study enrollment to maximum 28 weeks of gestation
Result of birth(rate of death, weight, cause of hospitalization to NICU)
Measured: from study enrollment to maximum 37 weeks of gestation
Any complications occurred to newborn and mother
Measured: from study enrollment to maximum 37 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Han Wha Pharma Co., Ltd., Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Young Ju Kim, Ewha Womans University Mokdong Hospital
- Investigators
- Young Ju Kim, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304237
- Sponsor's protocol ID
- VICTORIA
- Status last verified
- Nov 2014
- First submitted
- 26 Nov 2014
- Last updated
- 1 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32536019
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Investigator Initiated Trial of Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women
- ClinicalTrials.gov ID
- NCT02304237
- Acronym / sponsor ID
- VICTORIA
- Conditions
- Premature Birth
- Keywords
- Premature Birth, progesterone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Han Wha Pharma Co., Ltd., Ministry of Health & Welfare, Korea
- Study start
- Dec 2014
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone | Experimental | Drug: Vaginal progesteroneVaginal progesterone(Utrogestan)200mg/day, during 14~21 weeks. |
| Intramuscular progesterone | Active comparator | Drug: Intramuscular progesteroneIntramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14~21 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal progesteroneAlso: Utrogestanmicronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes | Drug | Vaginal progesterone |
| Intramuscular progesteroneAlso: Progesterone Depot Jenapharm Injectionhydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes | Drug | Intramuscular progesterone |
Primary outcome
Preterm Birth Rate before 37 weeks of gestation
Time frame: from study enrollment to maximum 37 weeks of gestation
4 secondary outcomes
Preterm Birth Rate before 34 weeks of gestation
Time frame: from study enrollment to maximum 34 weeks of gestation
Preterm Birth Rate before 28 weeks of gestation
Time frame: from study enrollment to maximum 28 weeks of gestation
Result of birth(rate of death, weight, cause of hospitalization to NICU)
Time frame: from study enrollment to maximum 37 weeks of gestation
Any complications occurred to newborn and mother
Time frame: from study enrollment to maximum 37 weeks of gestation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2014.
- Derived from this study: PubMed 32536019Choi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Ju Kim principal investigator
Ewha Womans University Mokdong Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vaginal progesterone and Intramuscular progesterone in people with Premature Birth, run by Ewha Womans University Mokdong Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Ju Kim (822-2650-5500, kkyj@ewha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preterm Birth Rate before 37 weeks of gestation (time frame: from study enrollment to maximum 37 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2014.