Clinical trial NCT04342585: Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length
Official title: Randomised Controlled Trial Comparing Vaginal Pessary and Progestogen as an Intervention in Twin Pregnancy With Short Cervical Length to Prevent Spontaneous Preterm Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preterm Birth
Keywords: twin
vaginal pessary
vaginal progestogen
short cervix
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

Brief summary: A randomized clinical trial comparing vaginal progestogen and vaginal pessary as an intervention for twin pregnancies with short cervical length.

Detailed description: 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.

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

Primary outcomes:
measure: Spontaneous preterm birth
timeFrame: Through study completion up to 37 weeks
Secondary outcomes:
measure: Maternal age
timeFrame: Pre-intervention
measure: Race
timeFrame: Pre-intervention
measure: Maternal body mass index
timeFrame: Pre-intervention
measure: Parity
timeFrame: Pre-intervention
measure: Type of twin pregnancy
timeFrame: Pre-intervention
measure: Type of conception
timeFrame: Pre-intervention
measure: Gestational age at recruitment
timeFrame: Pre-intervention
measure: Gestational age at commencement of treatment
timeFrame: Pre-intervention
measure: Cervical length before commencement of treatment
timeFrame: Pre-intervention
measure: Vaginal infection
timeFrame: Pre-intervention
measure: Previous miscarriages
timeFrame: Pre-intervention
measure: Pre-existing medical disorders
timeFrame: Pre-intervention
measure: Previous spontaneous preterm birth
timeFrame: Pre-intervention
measure: Antenatal complications
timeFrame: Through study completion up to 37 weeks
measure: Fetal complications
timeFrame: Through study completion up to 37 weeks
measure: Mode of delivery
timeFrame: Through study completion up to 37 weeks
measure: Intrapartum complications
timeFrame: Throughout labour up to delivery of the neonate
measure: Postpartum complications
timeFrame: Through delivery of neonate up to 42 days after delivery
measure: Total blood loss
timeFrame: Through delivery of neonate up to 42 days after delivery
measure: Birth weight
timeFrame: Immediately after birth of neonate
measure: Apgar score
timeFrame: Immediately after birth of neonate
measure: Anthropometry assessment of neonates
timeFrame: Immediately after birth of neonate
measure: Neonatal intensive care unit admission
timeFrame: Immediately after birth of neonate up to discharge (approximately 30 days)
measure: Duration in neonatal intensive care unit
timeFrame: Through neonatal intensive care unit stay up to discharge (approximately 30 days)
measure: Neonatal complications
timeFrame: Immediately after birth up to 30 days
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: UKM Medical Centre
state: Kuala Lumpur
Study officials:
References: