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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
142
A diary will be given to participants to ensure compliance.
The internal diameter size will be decided based on the clinical assessment of the cervix.
UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia
Spontaneous preterm birth
Mean gestational age at delivery in weeks
Time frame: Through study completion up to 37 weeks
Maternal age
Mean maternal age in years
Time frame: Pre-intervention
Race
Percentage of each race recruited
Time frame: Pre-intervention
Maternal body mass index
Mean maternal body mass index in kg/m2 before pregnancy or in the first trimester
Time frame: Pre-intervention
Parity
Mean number of parity
Time frame: Pre-intervention
Type of twin pregnancy
Chorionicity of twin pregnancy
Time frame: Pre-intervention
Type of conception
Method of conception
Time frame: Pre-intervention
Gestational age at recruitment
Mean gestational age at recruitment in weeks
Time frame: Pre-intervention
Gestational age at commencement of treatment
Mean gestational age at commencement of treatment in weeks
Time frame: Pre-intervention
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Cervical length before commencement of treatment
Mean cervical length before commencement of treatment in mm
Time frame: Pre-intervention
Vaginal infection
Percentage of participants with vaginal infection prior to commencement of treatment
Time frame: Pre-intervention
Previous miscarriages
Percentage of participants with previous first and second trimester miscarriages
Time frame: Pre-intervention
Pre-existing medical disorders
Percentage of participants with pre-existing medical disorders
Time frame: Pre-intervention
Previous spontaneous preterm birth
Percentage of participants with previous spontaneous preterm birth
Time frame: Pre-intervention
Antenatal complications
Percentage of participants with antenatal complications
Time frame: Through study completion up to 37 weeks
Fetal complications
Percentage of participants with fetal complications
Time frame: Through study completion up to 37 weeks
Mode of delivery
Percentage of participants who delivered vaginally or via caesarean section
Time frame: Through study completion up to 37 weeks
Intrapartum complications
Percentage of participants with intrapartum complications
Time frame: Throughout labour up to delivery of the neonate
Postpartum complications
Percentage of participants with postpartum complications
Time frame: Through delivery of neonate up to 42 days after delivery
Total blood loss
Mean total blood loss in ml
Time frame: Through delivery of neonate up to 42 days after delivery
Birth weight
Mean birth weight in grams
Time frame: Immediately after birth of neonate
Apgar score
Mean Apgar score
Time frame: Immediately after birth of neonate
Anthropometry assessment of neonates
Mean length and head circumference of neonates at birth in cm
Time frame: Immediately after birth of neonate
Neonatal intensive care unit admission
Percentage of neonates required Neonatal intensive care unit admission
Time frame: Immediately after birth of neonate up to discharge (approximately 30 days)
Duration in neonatal intensive care unit
Mean duration in neonatal intensive care unit in days
Time frame: Through neonatal intensive care unit stay up to discharge (approximately 30 days)
Neonatal complications
Percentage of neonates with complications
Time frame: Immediately after birth up to 30 days