Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length
Randomised Controlled Trial Comparing Vaginal Pessary and Progestogen as an Intervention in Twin Pregnancy With Short Cervical Length to Prevent Spontaneous Preterm Birth
Lead Sponsor: National University of Malaysia
|Source||National University of Malaysia|
A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.
This is a randomized controlled trial to compare women with twin pregnancies and diagnosed with asymptomatic short cervical length. Two types of interventions will be compared i.e vaginal progestogen and vaginal pessary.
|Overall Status||Not yet recruiting|
|Start Date||July 1, 2020|
|Completion Date||July 31, 2022|
|Primary Completion Date||April 1, 2022|
Intervention Type: Drug
Intervention Name: Micronised vaginal progesterone
Description: A diary will be given to participants to ensure compliance.
Arm Group Label: Vaginal progestogen
Other Name: Utrogestan
Intervention Type: Device
Intervention Name: Vaginal pessary
Description: The internal diameter size will be decided based on the clinical assessment of the cervix.
Arm Group Label: Vaginal pessary
Other Name: Arabin pessary
Inclusion Criteria: - all twin pregnancies - cervical length less than 30mm Exclusion Criteria: - Twin to twin transfusion syndrome - Stillbirth - congenital anomaly in one of the fetuses - previous cervical trauma or surgery - cervical cerclage in current pregnancy - premature labour with or without rupture of membranes - severe vaginal discharge - acute vaginitis or cervicitis
- all twin pregnancies
- cervical length less than 30mm
- Twin to twin transfusion syndrome
- congenital anomaly in one of the fetuses
- previous cervical trauma or surgery
- cervical cerclage in current pregnancy
- premature labour with or without rupture of membranes
- severe vaginal discharge
- acute vaginitis or cervicitis
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: Accepts Healthy Volunteers
Type: Principal Investigator
Investigator Affiliation: National University of Malaysia
Investigator Full Name: Rahana Abd Rahman
Investigator Title: Co-primary investigator
|Has Expanded Access||No|
|Number Of Arms||2|
Label: Vaginal progestogen
Type: Active Comparator
Description: 200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation.
Label: Vaginal pessary
Type: Active Comparator
Description: Vaginal pessary with an internal diameter size of 32 or 35 mm will be inserted at the time of recruitment and kept until 34 weeks gestation.
|Study Design Info||
Intervention Model: Parallel Assignment
Intervention Model Description: All women with twin pregnancies will be screened for suitability via measurement of the cervical length at 20 to 24 weeks gestation. Those with a cervical length of 30mm or less will be recruited into the study.
Primary Purpose: Prevention
Masking: None (Open Label)