Clinical trial
Randomised Controlled Trial Comparing Vaginal Pessary and Progestogen as an Intervention in Twin Pregnancy With Short Cervical Length to Prevent Spontaneous Preterm Birth
Name
JEP-2020-065
Description
A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.
Trial arms
Trial start
2019-10-01
Estimated PCD
2022-09-30
Trial end
2022-09-30
Status
Completed
Phase
Early phase I
Treatment
Micronised vaginal progesterone
A diary will be given to participants to ensure compliance.
Arms:
Vaginal progestogen
Other names:
Utrogestan
Vaginal pessary
The internal diameter size will be decided based on the clinical assessment of the cervix.
Arms:
Vaginal pessary
Other names:
Arabin pessary
Size
142
Primary endpoint
Spontaneous preterm birth
Through study completion up to 37 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 142, 'type': 'ACTUAL'}}
Updated at
2024-01-23
1 organization
1 product
1 indication
Organization
National University of MalaysiaIndication
premature birth