The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes

Not Applicable

Completed

• Conditions: Antenatal Corticosteroid; Perinatal Problems; Preterm Pregnancy
• Interventions: Other: participants receiving Corticosteroid

• Registration Number: NCT06164080
• Lead Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

Brief Summary

In this study, the investigators aims to evaluate whether antenatal corticosteroid administration to women likely to give birth in the late preterm period will reduce early and late neonatal complications and contribute to the literature in this sense.

Detailed Description

This study is a single-center prospective case-control study investigating the effect of antenatal corticosteroids administered in the late preterm period on early and late perinatal outcomes. 459 patients who gave birth between 34-37 weeks between June 1,2021 to October 1,2022 in the Obstetrics and Gynecology Clinic of the University of Health Sciences were included. Patient were divided into two groups antenatal corticosteroid administration (n:231) and non-administration (n:228). Postpartum early and late perinatal outcomes were compared between these two groups.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Study First Submitted: 2023-04-04
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-01
• Last Update Submitted: 2023-12-01
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 459

Inclusion Criteria

• All pregnant women who had normal vaginal delivery, cesarean section or operative delivery between 34-37 weeks
• Singleton pregnancies resulting in a live birth

Exclusion Criteria

• Twin pregnancies
• All births before 34 weeks or after 37 weeks
• Pregnant women with intrauterine ex fetus
• Fetuses with major congenital and chromosomal abnormalities
• Pregnant women who administrated antenatal corticosteroids for any reason before 34 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Antenatal corticosteroid administration	participants receiving Corticosteroid	Pregnant women using antenatal corticosteroids for any reason before 34 weeks

Primary Outcome Measures

Name	Time	Method
The results of antenatal corticosteroid effects	16 months	intramuscular 3 mg betamethasone (dekort 8mg/2 ml) corticosteroid injection in perinatal period

Secondary Outcome Measures

Name	Time	Method
Other consequences of antenatal corticosteroid effects in late term pregnant women	16 months	Other consequences of antenatal corticosteroid administered in late preterm pregnant women in the neonatal period are the need for neonatal intensive care due to reasons other than respiratory distress, respiratory complications such as pneumonia, other complications such as sepsis, perinatal death, chronic lung disease (even after 28 days of birth, oxygen need) long-term outcomes in postnatal infants ( third month, sixth month, twelfth month, emotional and emotional consequences in the family, and maternal side effects.

Trial Locations

Locations (1)

Nefise Nazlı YENIGUL; 🇹🇷 Bursa, Turkey