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

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ClinicalTrials.gov Identifier: NCT02304237
Recruitment Status : Unknown
Verified November 2014 by Young Ju Kim, Ewha Womans University Mokdong Hospital.
Recruitment status was:  Not yet recruiting
First Posted : December 1, 2014
Last Update Posted : December 1, 2014
Sponsor:
Collaborators:
Samsung Medical Center
Han Wha Pharma Co., Ltd.
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Young Ju Kim, Ewha Womans University Mokdong Hospital

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.

Condition or disease Intervention/treatment Phase
Premature Birth Drug: Vaginal progesterone Drug: Intramuscular progesterone Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : December 2014
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaginal progesterone
Vaginal progesterone(Utrogestan)200mg/day, during 14~21 weeks.
Drug: Vaginal progesterone
micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes
Other Name: Utrogestan

Active Comparator: Intramuscular progesterone
Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14~21 weeks.
Drug: Intramuscular progesterone
hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes
Other Name: Progesterone Depot Jenapharm Injection




Primary Outcome Measures :
  1. Preterm Birth Rate before 37 weeks of gestation [ Time Frame: from study enrollment to maximum 37 weeks of gestation ]

Secondary Outcome Measures :
  1. Preterm Birth Rate before 34 weeks of gestation [ Time Frame: from study enrollment to maximum 34 weeks of gestation ]
  2. Preterm Birth Rate before 28 weeks of gestation [ Time Frame: from study enrollment to maximum 28 weeks of gestation ]
  3. Result of birth(rate of death, weight, cause of hospitalization to NICU) [ Time Frame: from study enrollment to maximum 37 weeks of gestation ]
  4. Any complications occurred to newborn and mother [ Time Frame: from study enrollment to maximum 37 weeks of gestation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304237


Contacts
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Contact: Young Ju Kim 822-2650-5500 kkyj@ewha.ac.kr
Contact: SUK-JOO CHOI 822-3410-3546 drmaxmix.choi@samsung.com

Sponsors and Collaborators
Ewha Womans University Mokdong Hospital
Samsung Medical Center
Han Wha Pharma Co., Ltd.
Ministry of Health & Welfare, Korea
Investigators
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Principal Investigator: Young Ju Kim Ewha Womans University Mokdong Hospital

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Responsible Party: Young Ju Kim, Professor, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT02304237     History of Changes
Other Study ID Numbers: VICTORIA
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: December 1, 2014
Last Verified: November 2014

Keywords provided by Young Ju Kim, Ewha Womans University Mokdong Hospital:
Premature Birth
progesterone

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs