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Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor

ConditionsRespiratory Distress Syndrome of NewbornThreatened Premature Labor, Antepartum
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-40
SponsorDongyang Liu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 20-40 (inclusive);

Body mass Index (BMI) 18.5-27.9kg /m2 (inclusive)

Single and twin pregnancy;

Premature delivery at 24-36 weeks;

Disqualifiers

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;

Trial population

288 Chinese pregnant women with preterm prematurity requiring dexamethasone treatment.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

288 Participants
are grouped into 8 trial groups

8

Trial groups

See each trial group below.

Group A: 0.5 h group
Group B: 2 h group
Group C: 4 h group
Group D: 6 h group
Group E: 12 h group
Group F: 24 h group
Group G: 36 h group
Group H: 48 h group

Trial outcomes

Primary outcomes

1

Respiratory distress syndrome

Whether respiratory distress syndrome occurs

Time frame
At birth
2

hypoglycemia

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

Time frame
Within 24 hours of birth
3

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.

Time frame
Six months
4

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.

Time frame
Two years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dongyang Liu

Lead sponsor

Peking University Third Hospital

Sponsor institution

Source ClinicalTrials.gov
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