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

Phase 3

• Conditions: Premature Birth
• Interventions: Drug: Vaginal progesterone; Drug: Intramuscular progesterone

• Registration Number: NCT02304237
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2014-11
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-11-26
• Last Update Submitted: 2014-11-26
• Study Start: 2014-12
• Study First Posted: 2014-12-01
• Last Update Posted: 2014-12-01
• Primary Completion: 2016-11
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 360

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal progesterone	Vaginal progesterone	Vaginal progesterone(Utrogestan)200mg/day, during 14\~21 weeks.
Intramuscular progesterone	Intramuscular progesterone	Intramuscular progesterone(Progesterone Depot Jenapharm Injection)250mg/week, during 14\~21 weeks.

Primary Outcome Measures

Name	Time	Method
Preterm Birth Rate before 37 weeks of gestation	from study enrollment to maximum 37 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Any complications occurred to newborn and mother	from study enrollment to maximum 37 weeks of gestation
Preterm Birth Rate before 28 weeks of gestation	from study enrollment to maximum 28 weeks of gestation
Preterm Birth Rate before 34 weeks of gestation	from study enrollment to maximum 34 weeks of gestation
Result of birth(rate of death, weight, cause of hospitalization to NICU)	from study enrollment to maximum 37 weeks of gestation