Vaginal Progesterone in Twin With Short Cervix

Study Overview
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Brief Summary
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Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix . Study Design: The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo).

Detailed Description
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Aim of the work The aim of this study is to assess the efficacy of the use of vaginal progesterone as a method of prevention of preterm labour in twin gestations with short cervix . Study Design: The study is designed as randomized ,placebo-controlled, clinical trial . All women with dichorionic diamniotic twin pregnancy will be followed up in the antenatal care at the out patient clinic. Randomization of cases will be done by computer method . 156 women with dichorionic diamniotic twin pregnancy and cervical length 10mm to 25mm detected on transvaginal sonogram between 20w to 24w gestational age were enrolled in the study and were distributed in two groups:group P (cases ) and group N (controls) . The randomization allocation was 1 : 1 (vaginal progesterone capsule : placebo). Inclusion Criteria : ( All pregnant women known to have Dichorionic Diamniotic twins diagnosed on 12 week dating scan will be offered transvaginal ultrasound scan to assess cervical length at 20-24 week anomaly scan ) and so inclusion criteria include: ( Dichorionic Diamniotic twins ) and both twins are living . (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks Exclusion Criteria : Cervical cerclage in place or planned . on tocolytic drugs . medically indicated preterm delivery < 35w of gestation . known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) . known contraindication to progesterone Liver dysfunction or disease Known or suspected malignancy of breast or genital organs Active thromboembolic disorder , or history of hormone-associated thromboembolic disorder known major structural or chromosomal fetal abnormality . Rupture of fetal membranes (leakage of amniotic fluid one or both sacs).

Official Title
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Evaluation of the Role of Vaginal Progesterone in Prevention of Preterm Labor in Twin Gestation With Short Cervix: Randomised Controlled Trial

Conditions
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Preterm Birth, Twin Dichorionic Diamniotic Placenta

Intervention / Treatment
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* Drug: Progesterone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ( All pregnant women known to have Dichorionic Diamniotic twins diagnosed on 12 week dating scan will be offered transvaginal ultrasound scan to assess cervical length at 20-24 week anomaly scan ) and so inclusion criteria include: ( Dichorionic Diamniotic twins ) and both twins are living . (Short Cervix 10-25mm) Diagnosed by transvaginal ultrasound scan between 20-24 weeks . Exclusion Criteria: 1 - Cervical cerclage in place or planned . 2- on tocolytic drugs . 3- medically indicated preterm delivery < 35w of gestation . 4- known allergy to progesterone or peanuts ( as the active treatment contain peanut oil) . 5- known contraindication to progesterone Liver dysfunction or disease Known or suspected malignancy of breast or genital organs Active thromboembolic disorder , or history of hormone-associated thromboembolic disorder 6- known major structural or chromosomal fetal abnormality . 7- Rupture of fetal membranes (leakage of amniotic fluid one or both sacs)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: progesterone<br>74 patients will receive progesterone pessary 200mg twice daily | Drug: Progesterone<br>* women will receive progesterone vaginal pesarries containing 200mg of progesterone twice daily . it will be used by the patient as one vaginal pessary per vagina twice per day . women will be showed how to use tablets . medication will be started at 20 -24 weeks and stopped at 36+6 weeks<br>* Other names: uterocare;|
| Placebo Comparator: Placebo<br>74 patients will receive placebo | Other: Placebo<br>* women will receive placebo pessary twice a day. women will be showed how to use tablets . medication will be started at 20-24 weeks and stopped at 36+6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| delivery at <37weeks of gestation | Preterm birth | 37 weeks gestation determined by 12 weeks dating scan | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse neonatal outcome | admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis | From date of delivery to date of hospital discharge up to 28 days | 
| preterm Delivery for different gestational age | preterm delivery | less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks | 
| Maternal adverse effects | Drug adverse effects | From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short cervix, twins, progesterone