Cervical Pessary vs Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial

• Status: Unknown status
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hillel Yaffe Medical Center
• Treatments: Progesterone

Criteria

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.