TerminatedNot Applicable

Pessary Versus Cerclage With or Without Progesterone in Twins

Stopped: Due to safety concerns as the PTB \<28 weeks and perinatal death rates were significantly higher in the pessary group, following the DSMC's recommendation.

Vietnam219 participantsStarted 2019-03-23

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Preterm birth <34 weeks

Timeframe: From date of randomisation until 33 6/7 weeks

Trial details

NCT IDNCT03863613

SponsorMỹ Đức Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-08

View on ClinicalTrials.gov More Preterm Birth trials