Clinical trial of a new protocol of lung maturation by administration of corticoids in twin pregnancy patients with threatened preterm birth treated by Atosiban : administration of 3 doses of betamethasone (12 mg) in 18 hours apart, rather than 2 doses of betamethasone (12 mg) in 24 hours apart as used usually, to decrease the risk of respiratory distress syndrome at the newborn children

Clinical trial on the administration of 3 doses of betamethasone (12 mg) in 18 hours apart in twin pregnancy patients with threatened preterm birth treated by Atosiban, rather than 2 doses of betamethasone (12 mg) in 24 hours apart, to decrease the risk of respiratory distress syndrome at the newborn children - CORTGEM 2

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003603-61-BE

Enrollment

Registered

2017-02-23

Start date

2017-07-19

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature delivery in twin pregnancies MedDRA version: 19.1 Level: LLT Classification code 10028244 Term: Multiple pregnancy affecting fetus or newborn System Organ Class: 100000004868 MedDRA version: 19.1 Level: LLT Classification code 10036564 Term: Pregnancy multiple System Organ Class: 100000004868

Interventions

Trade Name: Celestone Pharmaceutical Form: Injection INN or Proposed INN: BETAMETHASONE CAS Number: 378-44-9 Other descriptive name: CELESTONE Concentration unit: mg milligram(s) Concentration type: e

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 cardiotocography analysis (> 6 contractions/30 minutes) with open cervix (> 1 cm) on digital examination and/or ultrasound cervical length =65 years) no 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 ultrasound 3. Contra-indication to corticoid (infection) 4. Other treatment with corticoid (local or general) 5. Previous administration of corticoids for lung maturation in this pregnancy 6. Diabetes mellitus with insulin 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 respiratory distress syndrom in the two groups Grade of respiratory distress syndrom in the two groups ;Timepoint(s) of evaluation of this end point: Evaluation of these criteria at birth and during the stay in neonatalogy	—

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 respiratory distress syndrom in the two groups Grade of respiratory distress syndrom in the two groups ;Timepoint(s) of evaluation of this end point: Evaluation of these criteria at birth and during the stay in neonatalogy

—

Secondary

Measure	Time frame
Secondary end point(s): Gestational age at delivery Incidence of other neonatal complications Need for neonatal surfactant therapy in both groups Need for ventilator support Incidence of long-term respiratory complications;Timepoint(s) of evaluation of this end point: Evaluation of the first four criteria at birth and during the stay in neonatology The incidence of the long-term respiratory complications will be estimated at 12 and 22 months of life	—

Measure

Time frame

Secondary end point(s): Gestational age at delivery Incidence of other neonatal complications Need for neonatal surfactant therapy in both groups Need for ventilator support Incidence of long-term respiratory complications;Timepoint(s) of evaluation of this end point: Evaluation of the first four criteria at birth and during the stay in neonatology The incidence of the long-term respiratory complications will be estimated at 12 and 22 months of life

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026