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Completed

NCT Number: NCT06164080

The Effect Of Antenatal Corticosteroids On Early And Late Perinatal Outcomes

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.

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Key information

Conditions

Preterm Pregnancy Antenatal Corticosteroid Perinatal Problems

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

participants receiving Corticosteroid

Other

Pregnant women using antenatal corticosteroids for any reason before 34 weeks

Other names: betamethasone, dekort

Primary outcomes

  1. The results of antenatal corticosteroid effects

    Time frame: 16 months

    intramuscular 3 mg betamethasone (dekort 8mg/2 ml) corticosteroid injection in perinatal period

Secondary outcomes

  1. Other consequences of antenatal corticosteroid effects in late term pregnant women

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sanliurfa Mehmet Akif Inan Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 11, 2023
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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