Preterm Birth
Conditions
Keywords
twin, vaginal pessary, vaginal progestogen, short cervix
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.
Interventions
DRUGMicronised vaginal progesterone
A diary will be given to participants to ensure compliance.
DEVICEVaginal pessary
The internal diameter size will be decided based on the clinical assessment of the cervix.
Sponsors
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous preterm birth | Through study completion up to 37 weeks | Mean gestational age at delivery in weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Race | Pre-intervention | Percentage of each race recruited |
| Maternal body mass index | Pre-intervention | Mean maternal body mass index in kg/m2 before pregnancy or in the first trimester |
| Parity | Pre-intervention | Mean number of parity |
| Type of twin pregnancy | Pre-intervention | Chorionicity of twin pregnancy |
| Type of conception | Pre-intervention | Method of conception |
| Gestational age at recruitment | Pre-intervention | Mean gestational age at recruitment in weeks |
| Gestational age at commencement of treatment | Pre-intervention | Mean gestational age at commencement of treatment in weeks |
| Cervical length before commencement of treatment | Pre-intervention | Mean cervical length before commencement of treatment in mm |
| Vaginal infection | Pre-intervention | Percentage of participants with vaginal infection prior to commencement of treatment |
| Previous miscarriages | Pre-intervention | Percentage of participants with previous first and second trimester miscarriages |
| Pre-existing medical disorders | Pre-intervention | Percentage of participants with pre-existing medical disorders |
| Previous spontaneous preterm birth | Pre-intervention | Percentage of participants with previous spontaneous preterm birth |
| Maternal age | Pre-intervention | Mean maternal age in years |
| Fetal complications | Through study completion up to 37 weeks | Percentage of participants with fetal complications |
| Mode of delivery | Through study completion up to 37 weeks | Percentage of participants who delivered vaginally or via caesarean section |
| Intrapartum complications | Throughout labour up to delivery of the neonate | Percentage of participants with intrapartum complications |
| Postpartum complications | Through delivery of neonate up to 42 days after delivery | Percentage of participants with postpartum complications |
| Total blood loss | Through delivery of neonate up to 42 days after delivery | Mean total blood loss in ml |
| Birth weight | Immediately after birth of neonate | Mean birth weight in grams |
| Apgar score | Immediately after birth of neonate | Mean Apgar score |
| Anthropometry assessment of neonates | Immediately after birth of neonate | Mean length and head circumference of neonates at birth in cm |
| Neonatal intensive care unit admission | Immediately after birth of neonate up to discharge (approximately 30 days) | Percentage of neonates required Neonatal intensive care unit admission |
| Duration in neonatal intensive care unit | Through neonatal intensive care unit stay up to discharge (approximately 30 days) | Mean duration in neonatal intensive care unit in days |
| Neonatal complications | Immediately after birth up to 30 days | Percentage of neonates with complications |
| Antenatal complications | Through study completion up to 37 weeks | Percentage of participants with antenatal complications |
Countries
Malaysia
Outcome results
None listed