Adverse Maternal and Neonatal OutcomesNCT04808375
Risk Factors for Pregnancy-induced Hypertension in Pregnant Patients Undergoing Cesarean Section
An observational study of Adverse Maternal and Neonatal Outcomes, run by RenJi Hospital at 1 site in China.
Trial summary
After Institutional Review Board approval, we performed a retrospective cohort study among all women presenting for pregnancy-induced hypertension under Cesarean section in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020.Perioperative data were collected, including… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Adverse Maternal and Neonatal Outcomes
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2021to 30 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation
Who may be able to join
- all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Risk Factors for Pregnancy-induced Hypertension in Pregnant Patients Undergoing Cesarean Section: a Retrospective Study
After Institutional Review Board approval, we performed a retrospective cohort study among all women presenting for pregnancy-induced hypertension under Cesarean section in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020.Perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, electrocardiogram, cardiac ultrasound, etc.), perioperative indicators, postoperative laboratory examination (blood routine, blood coagulation, liver and kidney function, etc.), postoperative follow-up and satisfaction survey of patients.
- Conditions
- Adverse Maternal and Neonatal Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse maternal outcomes
Adverse maternal outcomes were evaluated individually and as a composite and included number of acute kidney injury (serum creatinine >1.1 mg/dL or oliguria), number of blood transfusion, number of eclampsia, rate of intensive care unit (ICU) admission, number of postpartum hemorrhage, or pulmonary edema.(From date of randomization until the date of discharged from hospital, whichever came first, assessed up to 40 weeks").
Measured: 42 days after delivery
Adverse neonatal outcomes
Number of neonatal outcomes included preterm birth (PTB; <37 weeks), Number of neonatal ICU (NICU) admission, number of neonatal intubation, and number of respiratory distress syndrome.（From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40weeks）.(From the date of birth until the date of discharged from hospital, whichever came first, assessed up to 5 weeks").
Measured: 42 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start30 Mar 2021 (estimated)
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Maternal and Neonatal OutcomesStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04808375
- Sponsor's protocol ID
- 20210303
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Pregnancy-induced Hypertension in Pregnant Patients Undergoing Cesarean Section: a Retrospective Study
- ClinicalTrials.gov ID
- NCT04808375
- Acronym / sponsor ID
- 20210303
- Conditions
- Adverse Maternal and Neonatal Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 30 Mar 2021 (estimated)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 22 Mar 2021 (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.
After Institutional Review Board approval, we performed a retrospective cohort study among all women presenting for pregnancy-induced hypertension under Cesarean section in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020.Perioperative data were collected, including preoperative general condition, laboratory examination, auxiliary examination (blood routine, blood coagulation, liver and kidney function, electrocardiogram, cardiac ultrasound, etc.), perioperative indicators, postoperative laboratory examination (blood routine, blood coagulation, liver and kidney function, etc.), postoperative follow-up and satisfaction survey of patients.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation
Key inclusion criteria (1 listed)
- all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other | – |
Primary outcome
Adverse maternal outcomes
Time frame: 42 days after delivery
Adverse maternal outcomes were evaluated individually and as a composite and included number of acute kidney injury (serum creatinine >1.1 mg/dL or oliguria), number of blood transfusion, number of eclampsia, rate of intensive care unit (ICU) admission, number of postpartum hemorrhage, or pulmonary edema.(From date of randomization until the date of discharged from hospital, whichever came first, assessed up to 40 weeks").
Adverse neonatal outcomes
Time frame: 42 days after delivery
Number of neonatal outcomes included preterm birth (PTB; <37 weeks), Number of neonatal ICU (NICU) admission, number of neonatal intubation, and number of respiratory distress syndrome.（From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 40weeks）.(From the date of birth until the date of discharged from hospital, whichever came first, assessed up to 5 weeks").
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
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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. This study is not recruiting at the moment.
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 Adverse Maternal and Neonatal Outcomes, run by RenJi Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Huang, M.S. (+8615921108822, huangdan363@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse maternal outcomes (time frame: 42 days after delivery). The study lists 2 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 22 Mar 2021.