Efficacy of eicosapentaenoic acid on the prevention of preterm birth in women with cervical shortening
- Conditions
- threatened preterm delivery
- Registration Number
- JPRN-jRCTs031180364
- Lead Sponsor
- agamatsu Takeshi
- Brief Summary
It was shown that the EPA treatment can significantly prevent preterm birth as compared with histrical control. In addition, the significant extension of gestation period, increased birth weight, decreased occurrence of neonatal adverse event, shortened the duration of hospital stays, and the duration of use of a tocolytic agent (ritodrine hydrochloride preparation, magnesium sulfate preparation) were shown in EPA treatment group, compared with histrical control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 98
1)Between 24 to 28weeks of gestation, pregnant women with shortened cervix length (< or = 25 mm)
or Between 29 to 33weeks of gestation, pregnant women with shortened cervix length (< or = 30 mm)
2)Pregnant woman who is at 20 years old or more.(at the time of informed consent)
3)Patients who were required to provide written informed consent
1)Patients with a past history of conization
2)Patients who underwent cervical cerclage in current pregnancy
3)Premature rupture of the membrane
4)fetal anomalies detected by ultrasonography
5)Prolapsed fetal membranes
6)Chorioamnionitis
7)Placenta previa
8)Multiple pregnancy
9)Painful degeneration of myomas during pregnancy
10)Uterine malformations
11)Previous medication of eicosapentaenoic acid
12)Medication with low-dose aspirin
13)Patients judged to be ineligible by attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Preterm birth
- Secondary Outcome Measures
Name Time Method 1)gestational age at delivery <br>2)Birth weight, Apgar score, pH of umbilical arterial blood <br>3)Cervical length <br>4)Maternal adverse event <br>5)Neonatal adverse event <br>6)Occurrence of adverse events toward neonates <br>7)Duration of hospital stays <br>8)Duration of use of a tocolytic agent (ritodrine hydrochloride preparation, magnesium sulfate preparation) <br>9)Nutrient intakes