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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02304237
• Other study ID #: VICTORIA
• Status: Not yet recruiting
• Phase: Phase 3
• First received: November 26, 2014
• Last updated: November 26, 2014
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2014
• Source: Ewha Womans University Mokdong Hospital
• Contact: Young Ju Kim
• Phone: 822-2650-5500
• Email: kkyj[@]ewha.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth

Intervention

Drug:
• Vaginal progesterone
micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes
• Intramuscular progesterone
hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital	Han Wha Pharma Co., Ltd., Ministry of Health & Welfare, Korea, Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm Birth Rate before 37 weeks of gestation		from study enrollment to maximum 37 weeks of gestation	No
Secondary	Preterm Birth Rate before 34 weeks of gestation		from study enrollment to maximum 34 weeks of gestation	No
Secondary	Preterm Birth Rate before 28 weeks of gestation		from study enrollment to maximum 28 weeks of gestation	No
Secondary	Result of birth(rate of death, weight, cause of hospitalization to NICU)		from study enrollment to maximum 37 weeks of gestation	Yes
Secondary	Any complications occurred to newborn and mother		from study enrollment to maximum 37 weeks of gestation	Yes