The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes

Perinatal Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06164080
• Other study ID #: 2011-KAEK-25 2021/05-10
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: December 2023
• Source: Sanliurfa Mehmet Akif Inan Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Perinatal Problems
• Premature Birth
• Preterm Pregnancy

Intervention

Other:
• participants receiving Corticosteroid
Pregnant women using antenatal corticosteroids for any reason before 34 weeks

Locations

Country	Name	City	State
Turkey	Nefise Nazli YENIGUL	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Sanliurfa Mehmet Akif Inan Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The results of antenatal corticosteroid effects	intramuscular 3 mg betamethasone (dekort 8mg/2 ml) corticosteroid injection in perinatal period	16 months
Secondary	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