Twin; Pregnancy, Affecting Fetus or Newborn
Conditions
Keywords
Preterm birth, Twin gestation, Vaginal progesterone, cervical cerclage
Brief summary
The objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Detailed description
There is a lack of effective, evidence-based interventions for the prevention of preterm birth in twin pregnancies. There is limited evidence for the use of vaginal progesterone and cervical cerclage, and the cervical pessary is currently only used within a research setting. There are no reported trials comparing the effectiveness of each of these interventions against each other, whether in isolation or in combination. Research is needed to further evaluate the benefit of the cervical pessary and the use of cervical cerclage in twins of women with a short cervix. A recent article by Stock et al.concludes by advising clinicians to share with women the uncertainty of methods to prevent PTB in multiple pregnancies, and offer the opportunity to participate in clinical trials. So the objective of the present study is to evaluate the effectiveness of vaginal progesterone and cervical cerclage each alone and in combination in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.
Interventions
PROCEDURECervical cerclage
Cervical cerclage indicated by short cervix ≤25mm
DRUGvaginal progesterone
Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
A randomized clinical trial open label
Intervention model description
A randomized clinical 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 16-20 weeks gestational age. * No symptoms, signs or other risk factors for preterm labor
Exclusion criteria
* Age \< 18 years or \> 45 years. * 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. * 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 | Up to 34 weeks gestational age | Number of patients with preterm birth before 34 weeks gestations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal respiratory distress syndrome | At birth | number of neonatal respiratory distress syndrome |
| Early neonatal death | within one month postpartum | number babies died in the neonatal period |
Countries
Egypt
Contacts
Primary Contacthany f sallam, md
Outcome results
None listed