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

Information source: Ewha Womans University Mokdong Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premature Birth

Intervention: Vaginal progesterone (Drug); Intramuscular progesterone (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Ewha Womans University Mokdong Hospital

Official(s) and/or principal investigator(s):
Young Ju Kim, Principal Investigator, Affiliation: Ewha Womans University Mokdong Hospital

Overall contact:
Young Ju Kim, Phone: 822-2650-5500, Email: kkyj@ewha.ac.kr

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.

Clinical Details

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

Primary outcome: Preterm Birth Rate before 37 weeks of gestation

Secondary outcome:

Preterm Birth Rate before 34 weeks of gestation

Preterm Birth Rate before 28 weeks of gestation

Result of birth(rate of death, weight, cause of hospitalization to NICU)

Any complications occurred to newborn and mother

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

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Young Ju Kim, Phone: 822-2650-5500, Email: kkyj@ewha.ac.kr

Additional Information

Starting date: December 2014
Last updated: November 26, 2014

Page last updated: August 23, 2015

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