Research to study efficacy of steroids in women who are delivered between 34 and 36plus6 weeks of gestation.

Efficacy and safety of antenatal steroids for late preterm delivery in a low-middle income countryâ?? A randomized double blind placebo controlled trial. - CLAP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021321

Enrollment

1200

Registered

2019-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: O601- Preterm labor with preterm delivery

Interventions

Intervention1: Inj. Betamethasone: Inj. Betamethasone 12mg IM Q24H x 2 doses Control Intervention1: Placebo: Placebo injection IM Q24H x 2 doses

Eligibility

Inclusion criteria

Inclusion criteria: All women requiring delivery between 34 and 36plus6 weeks for : -Preeclampsia -IUGR or Oligohydraminos -GDM -PPROM -Preterm labour with possible delivery within 1 week (more than 3cms dilated or 75 percent effacement) -Any other reason for preterm delivery

Exclusion criteria

Exclusion criteria: -Definite evidence of infection -Abruptio placenta -Pregestational diabetes -TWINS -Received previous course of steroids -Expected delivery within 12 hours (dilatation more than 8 cms with Regular contractions) -Lack of early dating scan -Major congenital anomalies and lung anomalies detected antenatally

Design outcomes

Primary

Measure	Time frame
Respiratory distress in the newborn baby defined as tachypnea, grunting, chest indrawing, nasal flare, cyanosis or need for oxygen persisting beyond 2 hours of lifeTimepoint: 2 hours after birth	—

Secondary

Measure	Time frame
Apnea in babyTimepoint: 1 month after birth;Bronchopulmonary dysplasi (BPD) in babyTimepoint: 4 weeks after birth;Early neonatal deathTimepoint: 7 days after birth;EndometritisTimepoint: 6 weeks after delivery;Hyperbilirubinemia in babyTimepoint: 2 weeks after birth;Hypoglycaemia in babyTimepoint: 1 week after birth;Intraventricular hemorrhage (IVH) in babyTimepoint: 2 weeks after birth;Length of hospitalisation of babyTimepoint: Till discharge of baby;Maternal ChorioamnionitisTimepoint: At delivery;Necrotising enterocolitis (NEC)Timepoint: 4 weeks after birth;Need for respiratory support- Oxygen/CPAP/Ventilation in newbornTimepoint: 2 weeks after birth;Post operative infection in motherTimepoint: 2 weeks after delivery;Puerperal sepsisTimepoint: 6 weeks;Respiratory distress syndrome (RDS) in babyTimepoint: 1 week after birth;Sepsis in babyTimepoint: 4 weeks after birth;StillbirthTimepoint: At birth;Transient tachypnea of newborn (TTN) in babyTimepoint: 1 week after birth;Use of surfactant in the babyTimepoint: 1 week after birth	—

Measure

Time frame

Apnea in babyTimepoint: 1 month after birth;Bronchopulmonary dysplasi (BPD) in babyTimepoint: 4 weeks after birth;Early neonatal deathTimepoint: 7 days after birth;EndometritisTimepoint: 6 weeks after delivery;Hyperbilirubinemia in babyTimepoint: 2 weeks after birth;Hypoglycaemia in babyTimepoint: 1 week after birth;Intraventricular hemorrhage (IVH) in babyTimepoint: 2 weeks after birth;Length of hospitalisation of babyTimepoint: Till discharge of baby;Maternal ChorioamnionitisTimepoint: At delivery;Necrotising enterocolitis (NEC)Timepoint: 4 weeks after birth;Need for respiratory support- Oxygen/CPAP/Ventilation in newbornTimepoint: 2 weeks after birth;Post operative infection in motherTimepoint: 2 weeks after delivery;Puerperal sepsisTimepoint: 6 weeks;Respiratory distress syndrome (RDS) in babyTimepoint: 1 week after birth;Sepsis in babyTimepoint: 4 weeks after birth;StillbirthTimepoint: At birth;Transient tachypnea of newborn (TTN) in babyTimepoint: 1 week after birth;Use of surfactant in the babyTimepoint: 1 week after birth

—

Countries

India

Contacts

Public ContactBenjamin Jeyanth Ross

Christian Medical College Hospital

benjiross@yahoo.com04162283311

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026