The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes

The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes In Late Preterm Pregnant Women

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.

Study Overview

• Status: Completed
• Conditions: Perinatal Problems; Preterm Pregnancy; Antenatal Corticosteroid
• Intervention / Treatment: Other: participants receiving Corticosteroid

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 Type: Interventional
• Enrollment (Actual): 459
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bursa, Turkey, 16110
    • Nefise nazlı Yenigül

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Antenatal corticosteroid non-administration; Pregnant women who did not use antenatal corticosteroid before 34 weeks
Active Comparator: Antenatal corticosteroid administration; Pregnant women using antenatal corticosteroids for any reason before 34 weeks	Other: participants receiving Corticosteroid; Pregnant women using antenatal corticosteroids for any reason before 34 weeks; Other Names: betamethasone; dekort

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other consequences of antenatal corticosteroid effects in late term pregnant women	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.	16 months

Collaborators and Investigators

• Sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Antenatal corticosteroids; Late preterm pregnancy; Late perinatal outcomes
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone
• Other Study ID Numbers: 2011-KAEK-25 2021/05-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No