Pessary Versus Cerclage With or Without Progesterone in Twins

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

Summary

This study compares the effectiveness of cervical pessary and cervical cerclage with or without vaginal progesterone for prevention of preterm birth in women with a twin pregnancy and a cervix ≤28 mm.

Participants will be randomly assigned in a 1:1:1:1 ratio to receive cerclage, pessary, cerclage plus progesterone or pessary plus progesterone.

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

Details

• Lead Sponsor: Mỹ Đức Hospital
• Collaborator: My Duc Phu Nhuan Hospital
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• Women with a twin pregnancy (mono- and di-chorionic)

• 16 0/7 to 22 0/7 weeks of gestation

• Maternal age ≥18 yrs

• Cervical length ≤28 mm

• Informed consent

• Not participating in another preterm birth study at the same time

Exclusion Criteria:

• Uterine anomalies

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

• Twin-to-twin transfusion syndrome

• Stillbirth or major congenital abnormalities in any of the fetus

• Severe vaginal discharge

• Acute vaginitis or cervicitis

• Vaginal bleeding

• Placental preavia

• Vasa preavia

• Premature rupture of membranes

• Premature labor with/without ruptured membrane

• Suspicion of chorioamnionitis

• Cerclage or pessary in place or unable to undergo cervical cerclage or pessary