Comparison Between Vaginal Pessary and Progestogen in Twin Pregnancy With Short Cervical Length

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

Detailed Description
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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.

Official Title
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Randomised Controlled Trial Comparing Vaginal Pessary and Progestogen as an Intervention in Twin Pregnancy With Short Cervical Length to Prevent Spontaneous Preterm Birth

Conditions
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Preterm Birth

Intervention / Treatment
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* Drug: Micronised vaginal progesterone
* Device: Vaginal pessary


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vaginal progestogen<br>200mg of vaginal progestogen will be inserted before bedtime every day from time of recruitment until 34 weeks gestation. | Drug: Micronised vaginal progesterone<br>* A diary will be given to participants to ensure compliance.<br>* Other names: Utrogestan;|
| Active Comparator: Vaginal pessary<br>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. | Device: Vaginal pessary<br>* The internal diameter size will be decided based on the clinical assessment of the cervix.<br>* Other names: Arabin pessary;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous preterm birth | Mean gestational age at delivery in weeks | Through study completion up to 37 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal age | Mean maternal age in years | Pre-intervention | 
| Race | Percentage of each race recruited | Pre-intervention | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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twin, vaginal pessary, vaginal progestogen, short cervix