Status:
UNKNOWN
Pessary Versus Progesterone in Singletons
Lead Sponsor:
Mỹ Đức Hospital
Collaborating Sponsors:
My Duc Phu Nhuan Hospital HCMC, Vietnam
Quang Ninh Obstetrics and Pediatrics Hospital, Quang Ninh, Vietnam
Conditions:
Preterm Birth
Short Cervix
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 randoml...
Detailed Description
This open label, multi-center, randomized controlled trial aims to compare the effectiveness of cervical pessary to vaginal progesterone for prevention of PTB in women with singleton pregnancies and a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
804 Patients enrolled
Trial Details
Trial ID
NCT04300322
Start Date
May 1 2020
End Date
December 1 2022
Last Update
October 9 2020
Active Locations (3)
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1
My Duc Phu Nhuan Hospital
Ho Chi Minh City, Phu Nhuan, Vietnam
2
Mỹ Đức Hospital
Ho Chi Minh City, Tan Binh, Vietnam
3
Quang Ninh Obstetrics and Pediatrics Hospital
Quang Ninh, Vietnam