Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Distress Syndrome of Newborn; Threatened Premature Labor, Antepartum

Detailed Description

This study was a single-center, open clinical study. Maternal blood, feces, umbilical venous blood, and placental tissue were collected from GW24-36 Chinese women with preterm labor treated with dexamethasone, excluding placental abruption, severe intrauterine bleeding, or women who met the exclusion criteria. The determination and implementation of dexamethasone treatment by clinicians are executed according to the guidelines, the sample collected in addition to collecting feces and an active medication before an initiative to collect blood after medication, the other is to pregnant women normal diagnosis and treatment after operation opportunity or placental blood collection way, this study does not interfere with the normal of maternal pregnancy, production, and diagnosis and treatment process. A total of 288 Chinese pregnant women with preterm preterm birth who required dexamethasone treatment were randomly divided into eight groups with 36 participants in each group. At admission, blood was retained for each group after biochemical or routine blood test and blood was abandoned once (2 mL). After that, subjects were treated with DEX (5 mg intramuscularization, Q12h, for 2 days, if there was still no delivery 7 days after the first drug administration, another course of treatment or treatment as prescribed by the doctor). During the study period, do not take any food or drugs (such as coffee, alcohol, hypoglycemic drugs and other drugs used with caution or prohibited by pregnant women) that may affect the safety of the fetus. 2 mL of venous blood was collected from each group at 0.5 h, 2 h, 4 h, 6 h, 12 h, 24 h, 36 h, 48 h after the first administration. Blood biochemical or blood routine waste blood at the last prenatal examination was collected in each group, and umbilical venous blood was collected postpartum. Placenta samples were collected postpartum. All samples will be tested for dexamethasone and its metabolite concentrations, pharmacodynamics and safety indicators, hormones and metabolomics. Neonatal development was evaluated by PEABODY score and Bailey Scale at 6 and 24 months postnatal.

• Study Type: Observational
• Enrollment (Anticipated): 288

Contacts and Locations

• Study Contact: Name: Song Jie; Phone Number: 86-17302556737; Email: fssongjie@163.com

Study Locations

• China
  • Beijing, China, 100191
    • Recruiting
    • Dongyang Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

288 Chinese pregnant women with preterm prematurity requiring dexamethasone treatment.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dongyang Liu
• Investigators: Principal Investigator: Liu Dongyang, Drug Clinical Trial Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Dexamethasone; Preterm; P-glycoprotein; Quantitative pharmacology
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Obstetric Labor, Premature
• Other Study ID Numbers: DCTC-IIR202108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No