Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

NCT05207852 | Recruiting

• 1 other identifier: DCTC-IIR202108
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

This study through to the pregnant woman blood concentrations of dexamethasone therapy after research, explore the pharmacokinetic data of dexamethasone in pregnant women, Chinese pregnant women dexamethasone pharmacokinetic model, provide a reference for the clinical use of dexamethasone dose, through the biomarkers of dexamethasone to promote fetal lung maturity and other metabolomics, It provides the basis for the effectiveness and safety study of dexamethasone.

Conditions

Respiratory Distress Syndrome of Newborn; Threatened Premature Labor, Antepartum

Keywords

Dexamethasone; Pregnancy; Preterm; Quantitative pharmacology; P-glycoprotein

Outcome Measures

Primary Outcomes (6)

• Respiratory distress syndrome

  Whether respiratory distress syndrome occurs

  At birth

• hypoglycemia

  Record fetal blood glucose (hypoglycemia within 1 hour, 3 hours, 6 hours, 24 hours after birth)

  Within 24 hours of birth

• PEABODY

  Evaluate the mental and physical development of the newborn, including 2, 1 and 0, of which 2 is the best and 0 is the worst.

  Six months

• PEABODY

  Evaluate the mental and physical development of the newborn, including 2, 1 and 0, of which 2 is the best and 0 is the worst.

  Two years

• BayleyScales of Infant and Toddler Development

  Evaluate the mental and physical development of the newborn. Each infant's score on the Mental and motor scales was converted by age group into a standard score with an average of 100 and a standard deviation of 16, The Mental Development Index and Psychomotor Development Index were calculated.

  Six months

• BayleyScales of Infant and Toddler Development

  Evaluate the mental and physical development of the newborn. Each infant's score on the Mental and motor scales was converted by age group into a standard score with an average of 100 and a standard deviation of 16, The Mental Development Index and Psychomotor Development Index were calculated.

  Two years

Study Arms (8)

0.5 h group

Blood samples were taken 0.5 h after dexamethasone administration

2 h group

Blood samples were taken 2 h after dexamethasone administration

4 h group

Blood samples were taken 4 h after dexamethasone administration

6 h group

Blood samples were taken 6 h after dexamethasone administration

12 h group

Blood samples were taken 12 h after dexamethasone administration

24 h group

Blood samples were taken 24 h after dexamethasone administration

36 h group

Blood samples were taken 36 h after dexamethasone administration

48 h group

Blood samples were taken 48 h after dexamethasone administration

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

288 Chinese pregnant women with preterm prematurity requiring dexamethasone treatment.

You may qualify if:

• Aged 20-40 (inclusive);
• Body mass Index (BMI) 18.5-27.9kg /m2 (inclusive)
• Single and twin pregnancy;
• Premature delivery at 24-36 weeks;
• No antibiotics, prebiotics or probiotics were used one month before feces collection (such as Bifidobacterium triplex live powder, Lactobacillus acidophilus tablet, compound Lactobacillus acidophilus tablet, Bacillus subtilis diplex live intestinal capsule, etc.);
• Preeclampsia patients accounted for about 1/10 of each group;
• Use dexamethasone I.M. 5mg Q12h regimen (or other dexamethasone administration regimen) to promote fetal lung maturation.

You may not qualify if:

• Ectopic pregnancy;
• Suffering from diabetes, fetal distress, serious infectious diseases (such as sepsis, septic shock), fever;
• Those who have taken glucocorticoid drugs within 2 weeks before joining the clinical trial;
• Those who took clindamycin during the study period;
• Congenital fetal malformation or fetal hypoxia in early pregnancy;
• Convulsive patients;
• HIV/HCV/ HEPATITIS A, drug abuse history;
• Suffering from chorioamnitis, endometritis;
• Placental abruption, severe intrauterine bleeding;
• Pregnant women whose cervical dilation is greater than or equal to 4 cm or whose cervical length is less than or equal to 20 mm by ultrasound examination;
• Pregnant women who took food or drugs during the study that might affect the safety of the fetus;
• Pregnant women participating in other clinical trials.

Sponsors & Collaborators

• Dongyang Liu: lead

Study Sites (1)

Dongyang Liu

Beijing, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood; placenta

MeSH Terms

Conditions

Pulmonary Atelectasis; Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

• Liu Dongyang

  Drug Clinical Trial Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongyang Liu

CONTACT

（86）010-82266658; liudongyang@vip.sina.com

Song Jie

CONTACT

86-17302556737; fssongjie@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice director of Drug Clinical Trial Center

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 26, 2022
• Study Start: December 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)