MedPath

OVE MOM trial

Phase 2
Conditions
Preterm Labor
Registration Number
JPRN-jRCTs042180102
Lead Sponsor
Ozaki Yasuhiko
Brief Summary

The results of this trial suggested that cervical pessary did not reduce preterm delivery, but may delay shortening of cervical length. Vaginal discharge was increased by using cervical pessary, no other adverse events were observed. There were no cases of intrauterine fetal demise in both groups. Cervical pessary may shorten duration of hospitalization and medication. In conclusion, cervical pessary may become one of a choice of prophylactic treatment for preterm delivery.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
237
Inclusion Criteria

1)Pregnant women after 20 weeks gestation, who is disgnosed threatened miscarriage or threatened premature labor.
2)Cervical length of 25mm or less.
3)Women with informed consent for participation in this trial.

Exclusion Criteria

1)Women with multiple pregnant.
2)Majior fetal anomalies.
3)Painful regular uterine contractions.
4)Active vaginal bleeding.
5)Placenta previa.
6)Cervical myoma.
7)History of cone biopsy or cervical cerclage in situ.
8)Other pregnant women when study doctores conclude that they are not eligible for study enrollment.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Delivery less than 34 weeks gestation.
Secondary Outcome Measures
NameTimeMethod
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