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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).
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:
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
known major structural or chromosomal fetal abnormality .
Rupture of fetal membranes (leakage of amniotic fluid one or both sacs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| progesterone | Active Comparator | 74 patients will receive progesterone pessary 200mg twice daily |
|
| Placebo | Placebo Comparator | 74 patients will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| delivery at <37weeks of gestation | Preterm birth | 37 weeks gestation determined by 12 weeks dating scan |
| 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 |
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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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Abdelhafeez | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University, Maternity Hospital | Cairo | Egypt |
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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 |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Placebo | Other | 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 |
|
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 |
| D000091642 | Urogenital Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |