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

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.

Study Overview

• Status: Unknown
• Conditions: Premature Birth
• Intervention / Treatment: Drug: Vaginal progesterone; Drug: Intramuscular progesterone

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 Type: Interventional
• Enrollment (Anticipated): 360
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Progesterone Depot Jenapharm Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preterm Birth Rate before 37 weeks of gestation	from study enrollment to maximum 37 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 26, 2014
• First Submitted That Met QC Criteria: November 26, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Estimate): December 1, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: progesterone; Premature Birth
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: VICTORIA