Premature delivery in twin pregnancies MedDRA version: 9.1 Level: LLT Classification code 10036564 Term: Pregnancy multiple MedDRA version: 9.1 Level: LLT Classification code 10028244 Term: Multiple pregnancy affecting fetus or newborn
Conditions
Interventions
Trade Name: Celestone
Product Name: Celestone
Pharmaceutical Form: Injection*
Sponsors
Cliniques Universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. sign inform consent 2. normal twin pregnancy 3. mother's age between 18 and 40 years old 4. premature delivery risk based on the cardiotocography analysis (> 6 contractions / 30 minutes) with open cervix (> 1 cm) on digital examination and/or ultrasound cervical length =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. medical contra-indication for tocolysis (mother or fetus) 2. fetal distress based on the cardiotocography and/or ultrasouind 3. Contra-indication to corticoïd (infection) 4. Other treatment with corticoïd (local or general) 5. Previous administration of corticoïds for lung maturation in this pregnancy 6. Diabetes melitus with insuline therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduce the incidence of respiratory distress syndrome in twins;Secondary Objective: Reduce the other complications of prematurity in twins Describe the effectiveness of management of premature labor in twin pregnancy;Primary end point(s): ·Proportion of RDS in the two groups ·Gestationnal age at delivery ·Incidence of other neonatal complications ·Grade of the RDS in the two groups ·Need for neonatl surfactant therapy in both groups ·Need for ventilatory support ·Betamethasone pharmacocinetic in twins | — |
Countries
Belgium
Outcome results
None listed