NCT06164080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
Last Updated

December 11, 2023

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

April 4, 2023

Last Update Submit

December 1, 2023

Conditions

Preterm PregnancyAntenatal CorticosteroidPerinatal Problems

Keywords

Antenatal corticosteroidsLate preterm pregnancyLate perinatal outcomes

Outcome Measures

Primary Outcomes (1)

  • The results of antenatal corticosteroid effects

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

    16 months

Secondary Outcomes (1)

  • Other consequences of antenatal corticosteroid effects in late term pregnant women

    16 months

Study Arms (2)

Antenatal corticosteroid non-administration

NO INTERVENTION

Pregnant women who did not use antenatal corticosteroid before 34 weeks

Antenatal corticosteroid administration

ACTIVE COMPARATOR

Pregnant women using antenatal corticosteroids for any reason before 34 weeks

Other: participants receiving Corticosteroid

Interventions

participants receiving CorticosteroidOTHER

Pregnant women using antenatal corticosteroids for any reason before 34 weeks

Also known as: betamethasone, dekort
Antenatal corticosteroid administration

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nefise Nazlı YENIGUL

Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Betamethasone

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Assistant Professor Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

April 4, 2023

First Posted

December 11, 2023

Study Start

June 1, 2021

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

December 11, 2023

Record last verified: 2023-12

Locations

TU(1)