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| ID | Type | Description | Link |
|---|---|---|---|
| DIP-2019-028 | Other Grant/Funding Number | Dana Impak Perdana |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal progestogen | Active Comparator | 200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation. |
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| Vaginal pessary | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micronised vaginal progesterone | Drug | A diary will be given to participants to ensure compliance. |
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| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous preterm birth | Mean gestational age at delivery in weeks | Through study completion up to 37 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal age | Mean maternal age in years | Pre-intervention |
| Race | Percentage of each race recruited | Pre-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKM Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000624167 | Utrogestan |
| D010570 | Pessaries |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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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.
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| Vaginal pessary | Device | The internal diameter size will be decided based on the clinical assessment of the cervix. |
|
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| Maternal body mass index | Mean maternal body mass index in kg/m2 before pregnancy or in the first trimester | Pre-intervention |
| Parity | Mean number of parity | Pre-intervention |
| Type of twin pregnancy | Chorionicity of twin pregnancy | Pre-intervention |
| Type of conception | Method of conception | Pre-intervention |
| Gestational age at recruitment | Mean gestational age at recruitment in weeks | Pre-intervention |
| Gestational age at commencement of treatment | Mean gestational age at commencement of treatment in weeks | Pre-intervention |
| Cervical length before commencement of treatment | Mean cervical length before commencement of treatment in mm | Pre-intervention |
| Vaginal infection | Percentage of participants with vaginal infection prior to commencement of treatment | Pre-intervention |
| Previous miscarriages | Percentage of participants with previous first and second trimester miscarriages | Pre-intervention |
| Pre-existing medical disorders | Percentage of participants with pre-existing medical disorders | Pre-intervention |
| Previous spontaneous preterm birth | Percentage of participants with previous spontaneous preterm birth | Pre-intervention |
| Antenatal complications | Percentage of participants with antenatal complications | Through study completion up to 37 weeks |
| Fetal complications | Percentage of participants with fetal complications | Through study completion up to 37 weeks |
| Mode of delivery | Percentage of participants who delivered vaginally or via caesarean section | Through study completion up to 37 weeks |
| Intrapartum complications | Percentage of participants with intrapartum complications | Throughout labour up to delivery of the neonate |
| Postpartum complications | Percentage of participants with postpartum complications | Through delivery of neonate up to 42 days after delivery |
| Total blood loss | Mean total blood loss in ml | Through delivery of neonate up to 42 days after delivery |
| Birth weight | Mean birth weight in grams | Immediately after birth of neonate |
| Apgar score | Mean Apgar score | Immediately after birth of neonate |
| Anthropometry assessment of neonates | Mean length and head circumference of neonates at birth in cm | Immediately after birth of neonate |
| Neonatal intensive care unit admission | Percentage of neonates required Neonatal intensive care unit admission | 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 | Through neonatal intensive care unit stay up to discharge (approximately 30 days) |
| Neonatal complications | Percentage of neonates with complications | Immediately after birth up to 30 days |
| D000091642 | Urogenital Diseases |