Pessary Versus Progesterone in Singletons

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study compares the effectiveness of cervical pessary to vaginal progesterone for prevention of preterm birth in women with singleton pregnancies and a cervix ≤25 mm.

Participants will be randomly assigned in a 1:1 ratio to receive cervical pessary or vaginal progesterone.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mỹ Đức Hospital
• Collaborators: My Duc Phu Nhuan Hospital HCMC, Vietnam; Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Singleton pregnancies

• Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7-22 0/7 weeks of gestation)

• Not participating in any other study which has intervention on maternity or fetus at the same time

• Provision of written informed consent to participate as shown by a signature on the patient consent form.

Exclusion Criteria:

• Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina

• Major congenital abnormalities of the fetus

• Presence of severe vaginal discharge

• Presence of vaginitis or cervicitis

• Presence of vaginal bleeding

• Preterm premature rupture of membranes

• Premature labor without ruptured membrane at the time of screening

• Suspected chorioamnionitis

• Unable to have cervical pessary inserted

• Cerclage or pessary in place