Respiratory Distress Syndrome of NewbornNCT05207852
Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor
An observational study of Respiratory Distress Syndrome of Newborn and Threatened Premature Labor, Antepartum, run by Dongyang Liu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Respiratory Distress Syndrome of Newborn, Threatened Premature Labor, Antepartum
- How many people
- 288 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 288 Chinese pregnant women with preterm prematurity requiring dexamethasone treatment.
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Dongyang Liu
Beijing, 100191
Dongyang Liu, liudongyang@vip.sina.com
About this study
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.
Read the 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.
- Keywords
- Dexamethasone, Pregnancy, Preterm, Quantitative pharmacology, P-glycoprotein
- Medical subject headings
- Pulmonary Atelectasis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Respiratory distress syndrome
Whether respiratory distress syndrome occurs
Measured: At birth
hypoglycemia
Record fetal blood glucose (hypoglycemia within 1 hour, 3 hours, 6 hours, 24 hours after birth)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome of NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongyang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongyang Liu, Peking University Third Hospital
- Investigators
- Liu Dongyang, Principal investigator, Drug Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207852
- Sponsor's protocol ID
- DCTC-IIR202108
- Status last verified
- Jan 2022
- First submitted
- 13 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacology of Dexamethasone in Pregnant Women With Preterm Labor
- ClinicalTrials.gov ID
- NCT05207852
- Acronym / sponsor ID
- DCTC-IIR202108
- Keywords
- Dexamethasone, Pregnancy, Preterm, Quantitative pharmacology, P-glycoprotein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Dongyang LiuUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 288 Chinese pregnant women with preterm prematurity requiring dexamethasone treatment.
Key inclusion criteria (7 listed)
- 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.);
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Respiratory distress syndrome
Time frame: At birth
Whether respiratory distress syndrome occurs
hypoglycemia
Time frame: Within 24 hours of birth
Record fetal blood glucose (hypoglycemia within 1 hour, 3 hours, 6 hours, 24 hours after birth)
PEABODY
Time frame: Six months
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.
PEABODY
Time frame: Two years
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.
BayleyScales of Infant and Toddler Development
Time frame: Six months
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.
BayleyScales of Infant and Toddler Development
Time frame: Two years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liu Dongyang principal investigator
Drug Clinical Trial Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome of Newborn and Threatened Premature Labor, Antepartum, run by Dongyang Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongyang Liu (（86）010-82266658, liudongyang@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory distress syndrome (time frame: At birth). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.