Status:
TERMINATED
Pessary Versus Cerclage With or Without Progesterone in Twins
Lead Sponsor:
Mỹ Đức Hospital
Conditions:
Preterm Birth
Twin Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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....
Detailed Description
This open label, multi-center, two-by-two factorial, randomised controlled trial aims to compare the effectiveness of cervical pessary to cervical cerclage and also to determine the effectiveness of v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2023
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT03863613
Start Date
March 23 2019
End Date
July 29 2023
Last Update
February 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
My Duc Phu Nhuan Hospital
Ho Chi Minh City, Vietnam, 70000