Adverse Neonatal Outcomes with a Shortened Clinical Regimen of Dexamethasone.

NCT06569251 | Completed Phase 2 DMC

• 1 other identifier: PGO-UNAH-47-1-2024
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

Respiratory morbidity, including respiratory distress syndrome (RDS), is a serious complication of preterm birth and the leading cause of early neonatal mortality and disability. The effects of antenatal corticosteroid administration on fetal lung maturation have been widely studied in order to counteract such adverse perinatal outcomes of preterm birth. The dexamethasone regimen will be evaluated at different administration frequencies, but at the same total dose. The hypothesis is: The type of dexamethasone regimen administered for fetal lung maturation influences the incidence of perinatal complications.

Conditions

Preterm Birth; Distress Respiratory Syndrome

Keywords

preterm birth; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• neonatal complications

  Presence or absence of respiratory distress syndrome, necrotizing enterocolitis, intraventricular hemorrhage, cystic ventricular leukomalacia, or death after receiving any of the different antenatal corticosteroid regimens

  from the first intervention to Newborn discharge. on average less than 28 days

Secondary Outcomes (1)

• Maternal complications

  rom the first intervention to birth. on average less than 28 days

Study Arms (2)

Group intervention (shortened dexamethasone regimen)

EXPERIMENTAL

Dexamethasone 12 mg IM every day for 2 days. Total dose: 24 mg

Drug: Dexamethasone 12 mg QD

Group control (conventional dexamethasone regimen)

ACTIVE COMPARATOR

Dexamethasone 6 mg IM every 12 hours for 2 days. Total dose: 24 mg.

Drug: Dexamethasone 6 mg BID

Interventions

Dexamethasone 12 mg QD DRUG

Administration of dexamethasone to the mother as an inducer of fetal lung maturity. shortened scheme

Group intervention (shortened dexamethasone regimen)

Dexamethasone 6 mg BID DRUG

Administration of dexamethasone to the mother as an inducer of fetal lung maturity. standard Scheme

Group control (conventional dexamethasone regimen)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Delivery of a signed and dated informed consent form.
• Declared willingness to comply with all study procedures and availability during the duration of the study.
• Pregnant patient with 20 or more weeks of gestation determined by USG with clinically diagnosed threat of preterm labor (defined as uterine contractions with sufficient progressive frequency and intensity that allow dilation of the cervix before the 37th week of gestation).
• Pregnant patient admitted and birth in the Maternal and Child Hospital, Labor and Delivery room. Part.
• Delivery carried out at the Teaching Hospital.
• Patient with a diagnosis of premature rupture of membranes under conservative management.
• patient must know how to read and write
• Possess a cell phone or some other means of communication.
• Residing in the city of Tegucigalpa, Honduras.

You may not qualify if:

• Patients under 18 years of age.
• Patient with diagnosed psychiatric illnesses.
• Pregnant patient with threat of preterm birth who is also diagnosed with preeclampsia with data of severity and intrauterine growth restriction.
• Pregnant patient with threat of preterm birth who is also diagnosed with premature rupture of membranes.
• Pregnant patient with threat of preterm birth who is also diagnosed con corioamnionitis.
• Pregnant patient with threat of preterm birth who is also diagnosed with acute abdomen.
• Major fetal malformations
• Fetal death

Sponsors & Collaborators

• Ricardo A Gutierrez Ramirez, MD, MSc, FACOG: lead

Study Sites (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, 11101, Honduras

Location

Related Publications (3)

• Vogel JP, Chawanpaiboon S, Moller AB, Watananirun K, Bonet M, Lumbiganon P. The global epidemiology of preterm birth. Best Pract Res Clin Obstet Gynaecol. 2018 Oct;52:3-12. doi: 10.1016/j.bpobgyn.2018.04.003. Epub 2018 Apr 26.

  PMID: 29779863 BACKGROUND

• Brownfoot FC, Gagliardi DI, Bain E, Middleton P, Crowther CA. Different corticosteroids and regimens for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2013 Aug 29;(8):CD006764. doi: 10.1002/14651858.CD006764.pub3.

  PMID: 23990333 BACKGROUND

• Kastanek M, Frommlet F, Linsenmeier L, Helmer H. Influence of antenatal corticosteroid lung maturation on maternal inflammatory parameters. J Matern Fetal Neonatal Med. 2022 Mar;35(6):1210-1212. doi: 10.1080/14767058.2020.1743653. Epub 2020 Mar 31.

  PMID: 32233700 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pulmonary Atelectasis

Interventions

Dexamethasone; BID protein, human

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ricardo A Gutierrez Ramirez, MD, MSc

  Universidad Nacional Autonoma de Honduras

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both the patient and the principal investigator will know the intervention, the data analyst researcher does not know the group to which the patients have been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator for the Postgraduate Program in Gynecology and Obstetrics

Model Details: Experimental. Single-blind, parallel-group, non-inferiority randomized clinical trial.

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 26, 2024
• Study Start: March 1, 2024
• Primary Completion: November 24, 2024
• Study Completion: November 24, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

HO (1)