Antenatal corticosteroids prior to early term elective caesarean section: a multi-center, randomized controlled trial

Antenatal corticosteroids prior to early term elective caesarean section (from 37+0 to 38+6 weeks gestation): a multi-center, randomized controlled trial assessing the effects on maternal and neonatal short- and long-term outcomes

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300074647

Enrollment

Unknown

Registered

2023-08-11

Start date

2023-09-01

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

early term labor

Interventions

Intervention group:4 doses of 6 mg dexamethasone sodium phosphate by intramuscular injection into the buttock, 12 hours apart given within seven days of elective caesarean section

Control group:None

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women who plan to receive caesarean section at 37+0 to 38+6 weeks gestation 2. 18-40 years old 3. Singleton pregnancy 4. Understanding the study procedures, being able to follow up regularly, and having signed informed consent

Exclusion criteria

Exclusion criteria: 1. Intolerant to dexamethasone or other adrenal corticosteroids 2. Pregnancy complications: idiopathic thrombocytopenic purpura, thrombosis 3. Severe infection 4. Severe heart, liver and renal diseases 5. Mental illness or epilepsy 6. Fetal demise, or known major fetal anomaly 7. Medical history or medication contraindications that may interfere with the test results or increase the patient's risk 8. Any prior antenatal corticosteroid course during the pregnancy 9. Participation in another interventional study during the pregnancy

Design outcomes

Primary

Measure	Time frame
neonatal respiratory distress syndrome;neonatal temporary hyperrespiratory syndrome;neonatal asphyxia;neonatal hypoglycemia;rate of respiratory support;	—

Secondary

Measure	Time frame
NICU admission rate;length of NICU stay;maternal fever;chorioamnionitis;puerperal infection;	—

Countries

China

Contacts

Public ContactZhonghua Shi

Women's Hospital of Nanjing Medical University, Nanjing Maternity and Child Health Care Hostipal

jesse_1982@163.com+86 138 5181 2725

Outcome results

None listed

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