Preterm Birth Clinical Trial
Official title:
Cervical Pessary vs. Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial
The purpose of this randomized control trial is to determine whether cervical pessary plus
vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm
delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic
mid-pregnancy short cervix, in singleton and twin gestations.
All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24
completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed
with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to
participate in the clinical trial.
Women who meet eligible criteria will be invited to participate in the clinical trial.
Women will be randomly assigned into one of the following groups: group A (vaginal
progesterone) or group B (vaginal progesterone + pessary).
Follow-up visits for ultrasound assessment of fetal growth and cervical length will be
carried out every two weeks until 37 weeks of gestation.
Status | Not yet recruiting |
Enrollment | 430 |
Est. completion date | July 2019 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosed to be pregnant at up to 24+0 weeks of gestation, with a cervical length measurement of =25 mm with a singleton pregnancy, or =38 mm in twins pregnancy. - Does not meet with maternal/fetal/membrane/placental factors detailed in the exclusion criteria. - Willingness to comply with the protocol for the duration of the study. - Have signed an informed consent. Exclusion Criteria: - Fetal factors: major fetal abnormalities, death of one or both of the fetuses, twins- twin-to-twin transfusion syndrome, and severe growth retardation. - Maternal factors: prophylactic cervical cerclage in situ, painful regular uterine contractions, active labor, active vaginal bleeding, maternal age under 18, uterine abnormalities (i.e. two cervices), and severe uterine prolapse. - Membranes and placental factors: placenta previa, ruptured membranes. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hillel Yaffe Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | preterm birth before 34 weeks of gestation rate in singleton pregnancies | up to 20 weeks from recruitment | No | |
Primary | preterm birth before 32 weeks of gestation rate in twin pregnancies | up to 20 weeks from recruitment | No | |
Secondary | Other preterm birth age before 34, 28 weeks in twin pregnancies | up to 20 weeks from recruitment | No | |
Secondary | Neonatal/perinatal complications rate | Respiratory Distress Syndrome (RDS), necrotizing enterocolitis, intraventricular hemorrhage, proven neonatal sepsis, retinopathy of prematurity, bronchopulmonary dysplasia, periventricular leukomalacia, fetal death, neonatal death. Apgar score <7 at 5 minutes, birth weight <1500 g and <2500 g, use of mechanical ventilation, congenital anomaly. | up to 20 weeks from recruitment | Yes |
Secondary | Maternal Adverse events | vaginal discharge, vaginal pruritus, discontinuation of treatment because of adverse events, threatened preterm labor. | up to 20 weeks from recruitment | Yes |
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