Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
The use of progesterone in the prevention of preterm birth(PTB) in both singleton and multiple pregnancies has been extensively investigated. Arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. There is no benefit of universal vaginal progesterone to reduce PTB rates in multiple pregnancies. One meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. There appears to be no long-term harm caused to infants exposed to progesterone in utero. So the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| progesterone 400mg | Active Comparator | Women received vaginal progesterone suppositories in a dose of 400 mg(4 tablets) daily beginning at 18-22 weeks gestational age |
|
| progesterone 200mg plus placebo to progesterone 200 mg | Active Comparator | Women received vaginal progesterone suppositories in a dose of 200 mg(2 tablets) daily beginning at 18-22 weeks gestational age plus 2tablets placebo to vaginal progesterone |
|
| placebo to progesterone 400 mg | Placebo Comparator | Women received 4 tablets placebo to vaginal progesterone suppositories |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| progesterone 400mg | Drug | Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Preterm labor before 34 weeks gestations | Number of patients delivered before 34 weeks gestations | Up to 34 weeks gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal respiratory distress syndrome | Number of neonates develop respiratory distress syndrome | At birth |
| Measure | Description | Time Frame |
|---|---|---|
| Early neonatal death | number of neonates died within one month from birth | One month after birth |
Inclusion Criteria:
Exclusion Criteria:
Women pregnant in dichorionic twins.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f sallam, md | Contact | 01022336052 | 002 | hany.farouk@aswu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | Recruiting | Aswān | 81528 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
a double-blind randomized controlled trial
Not provided
Not provided
a double-blind randomized controlled trial
| progesterone 200mg | Drug | Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age |
|
|
| placebo to progesterone 200mg | Drug | Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age |
|
|
| placebo to progesterone 400mg | Drug | Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age |
|
|
| 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 |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | 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 |
Not provided
Not provided