Dexamethasone for Preterm Labour (PTL)

Assiut University

Status and phase: Completed; Phase 2

Conditions: Prematurity

Treatments: Drug: Dexamethasone 12; Drug: Dexamethasone 24 hours

Study type: Interventional

Funder types: Other

Identifiers

NCT01697098

Dexa WHH

Details and patient eligibility

About

The investigators sought to determine whether the incidence of neonatal respiratory distress syndrome (RDS) in preterm fetuses is similar with 12- vs 24-hour dosing interval of dexamethasone.

Full description

The administration of glucocorticoids to accelerate fetal lung maturity in patients with preterm delivery plays an important role for obstetrics and neonatal care. Many studies have shown that maternal administration of glucocorticoids has a significant beneficial effect in decreasing the incidence of respiratory distress syndrome (RDS) in infants delivered at 28-34 weeks of gestation.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patient with threatened or established preterm labor between 28 - 34 weeks attended to our emergency unit

Exclusion criteria

• emergent obstetric conditions like:

  • Antepartum hemorrhage in severe attack
  • Antepartum eclampsia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

12 hours Dexamethasone

Experimental group

Description:

Those patient will be given 12 hours dexamethasone after randomization

Treatment:

Drug: Dexamethasone 12

24 hours Dexamethasone

Experimental group

Description:

Those patient will be give 24 hours dexamethasone after randomization

Treatment:

Drug: Dexamethasone 24 hours