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

Ewha Womans University

Status and phase: Unknown; Phase 3

Conditions: Premature Birth

Treatments: Drug: Intramuscular progesterone; Drug: Vaginal progesterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02304237

VICTORIA

Details and patient eligibility

About

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.

Full 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

Enrollment: 360 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

Vaginal progesterone

Experimental group

Description:

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

Treatment:

Drug: Vaginal progesterone

Intramuscular progesterone

Active Comparator group

Description:

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

Treatment:

Drug: Intramuscular progesterone