A Clinical Pharmacological Study of Dose Halving of Dexamethasone in Pregnant Women With Preterm Labour With Preterm Birth at Greater Than or Equal to 34 Gestational Weeks (34GW+)

NCT06350565 | Not Yet Recruiting

• 1 other identifier: DEX20240104
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study plans to conduct a DEX dose halving study and a normal dose study in 34+0-35+6 GW women with preterm preterm labour. In addition, this study plans to conduct a DEX dose halving study and a normal dose study in 34-38+6 GW preterm pregnant women with GDM or diabetic co-pregnancy to explore the feasibility of dose halving in pregnant women with diabetes mellitus.

Conditions

Respiratory Distress Syndrome of Newborn

Keywords

Dexamethasone; Pregnancy; Quantitative pharmacology

Outcome Measures

Primary Outcomes (6)

• Respiratory distress syndrome

  Dependent on clinical presentation, arterial blood gas analysis, and chest X-ray. (1) progressive dyspnoea, expiratory groaning, inspiratory trigonocephaly, cyanosis, and markedly reduced or absent breath sounds on lung auscultation that appeared shortly after birth; (2) lung X-ray changes typical of RDS, with diffuse fine-grained reticulated ground-glass shadows accompanied by bronchial insufflation signs; and (3) exceptions to dyspnoea caused by simple severe pneumonia, meconium aspiration or pulmonary haemorrhage, etc.

  Detection and evaluation of the newborn within 24 hours of the end of delivery

• PK parameters (analysed in conjunction with population pharmacokinetic (PPK) modelling): area under the blood concentration curve, Cmax, Tmax, Kel, t1/2, CL, VZ

  Blood concentrations of dexamethasone and its metabolites and foetal blood concentrations

  2±0.5 h, 12 h after first dose

• Pharmacodynamics

  Biomarker assay and measurement of placental P-gp regulatory sensitive factor pregnancy blood concentrations.

  In the course of pregnancy (GW8-delivery), the blood samples were collected every 2 weeks on average, and the blood samples were collected during each delivery and at the time of delivery, and the exact time of delivery was slightly adjusted according to

• Measurability indicators

  Measurable indicators: neonatal head circumference, length, weight, blood pressure (diastolic/systolic);

  during labour

• Blood biochemistry findings in newborns

  Blood glucose concentration, blood triglyceride concentration, etc.

  during labour

• DEX potential safety marker test

  Maternal blood and umbilical vein blood were collected at the time of delivery and concentrations of potentially toxic biomarkers (e.g. ACTH, CORT, GABA, GAD67) were measured

  during labour

Study Arms (2)

Half-dose study

OTHER

A total of 24 Chinese pregnant subjects with 34+0-35+6 GW requiring dexamethasone treatment for preterm labour with preterm prematurity in China were planned to be enrolled in this study. A total of 12 subjects receiving 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the full-dose group; 12 subjects receiving 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses) were enrolled in the half-dose group.

Drug: Dexamethasone

An exploratory study

OTHER

This study was planned to enrol 24 pregnant women with 34+0-38+6 GW preterm labour with confirmed gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy in a dose exploratory study in this population. A total of 12 subjects were enrolled in the full-dose group to receive 5 mg dexamethasone (intramuscular injection, q12h, 4 doses) and 12 subjects were enrolled in the half-dose group to receive 2.5 mg dexamethasone (intramuscular injection, q12h, 4 doses).

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

This clinical study will plan to enrol 24 Chinese pregnant subjects with 34+0-35+6GW preterm preterm labour requiring dexamethasone treatment and 24 pregnant women with 34+0-38+6GW preterm preterm labour and a diagnosis of gestational diabetes mellitus (GDM) or diabetes mellitus in combination with pregnancy, each of them randomly divided into 2 groups requiring 4 doses of dexamethasone intramuscularly (half-dose of 2.5 mg, normal dose of 5 mg) for two days as well as two active blood acquisitions. During the recruitment and screening phase, the purpose of the trial, the study protocol, and the trial procedure were described in detail so that the subjects were fully informed and participated voluntarily, and the compliance of the subjects in the conduct of the trial was improved.

An exploratory study; Half-dose study

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Common criteria for half-dose studies and exploratory studies:
• Age 18-40 years (inclusive);
• Body mass index (BMI) 18.5-27.9 kg/m2 (inclusive).
• risk of preterm labour and use of dexamethasone for fetal lung maturation.
• Half-dose study-specific criteria:
• (1) Greater than or equal to 34+0 gestational weeks and less than or equal to 35+6 gestational weeks at enrolment;
• Exploratory study-specific criteria:
• Greater than or equal to 34+0 gestational weeks and less than or equal to 38+6 gestational weeks at enrolment;
• Confirmed diagnosis of GDM or having diabetes mellitus.

You may not qualify if:

• Multiple pregnancies (three or more pregnancies)
• For subjects who are unable to be included in this study in the following cases:
• Pregnant women with ectopic pregnancy
• Fetal distress, severe infectious (e.g. sepsis, infectious shock) disease, fever;
• Those who have taken glucocorticoid drugs within 2 weeks before joining the clinical trial;
• Those who took clindamycin during the study period;
• Those with congenital foetal anomalies or foetal hypoxia occurring in early pregnancy;
• Patients with convulsions;
• Those with a history of HIV/HCV/hepatitis A, substance abuse;
• Chorioamnionitis, endometritis;
• Placental abruption, use of surfactant, severe intrauterine haemorrhage;
• Pregnant women with cervical dilatation greater than or equal to 4 cm or ultrasonographic neck length greater than or equal to 20 mm;
• Pregnant women taking food or drugs during the study period that may affect foetal safety;
• Pregnant women participating in other clinical trials.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Dongyang Liu

CONTACT

18610966092; liudongyang@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director of Drug Clinical Trial Center

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 5, 2024
• Study Start: April 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share