Vaginal Progesterone in Twin With Short Cervix
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: progesterone 74 patients will receive progesterone pessary 200mg twice daily |
Drug: Progesterone
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
Other Names:
|
| Placebo Comparator: Placebo 74 patients will receive placebo |
Other: Placebo
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
|
Outcome Measures
Primary Outcome Measures
- delivery at <37weeks of gestation [37 weeks gestation determined by 12 weeks dating scan]
Preterm birth
Secondary Outcome Measures
- adverse neonatal outcome [From date of delivery to date of hospital discharge up to 28 days]
admission/Hypoglycaemia/Respiratory distress/feeding difficulty/sepsis
- preterm Delivery for different gestational age [less than 28 weeks, 28- 32 weeks, 32-34weeks, 34-37 weeks]
preterm delivery
- Maternal adverse effects [From randomization at 20-24 weeks till 37 weeks or delivery whichever occurs sooner]
Drug adverse effects
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ain Shams University, Maternity Hospital | Cairo | Egypt |
Sponsors and Collaborators
- Ain Shams University
Investigators
- Study Director: Mohamed Abdelhafeez, Ain Shams University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AIN-2222-RCT