Twin; Pregnancy, Affecting Fetus or Newborn
Conditions
Keywords
Preterm birth, Twin gestation, Vaginal progesterone
Brief summary
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.
Detailed description
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
Interventions
DRUGprogesterone 400mg
Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age
DRUGprogesterone 200mg
Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age
DRUGplacebo to progesterone 200mg
Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age
DRUGplacebo to progesterone 400mg
Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
a double-blind randomized controlled trial
Intervention model description
a double-blind randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women pregnant in dichorionic twins. * Transvaginal sonographic cervical length is \<25 mm at 18-22 weeks gestational age. * No symptoms, signs or other risk factors for preterm labor.
Exclusion criteria
* Known allergy or contraindication (relative or absolute) to progesterone therapy. * Monochorionic twins. * Known major fetal structural or chromosomal abnormality. * Intrauterine death of one fetus or death of both fetuses. * Fetal reduction in the current pregnancy. * Cervical cerclage in the current pregnancy. * Medical conditions that may lead to preterm delivery. * Rupture of membranes. * Vaginal bleeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preterm labor before 34 weeks gestations | Up to 34 weeks gestational age | Number of patients delivered before 34 weeks gestations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal respiratory distress syndrome | At birth | Number of neonates develop respiratory distress syndrome |
Other
| Measure | Time frame | Description |
|---|---|---|
| Early neonatal death | One month after birth | number of neonates died within one month from birth |
Countries
Egypt
Contacts
Primary Contacthany f sallam, md
Outcome results
None listed