Risk Factors for Pregnancy-induced Hypertension in Pregnant Patients Undergoing Cesarean Section

Adverse Maternal and Neonatal Outcomes Clinical Trial

Official title:

Risk Factors for Pregnancy-induced Hypertension in Pregnant Patients Undergoing Cesarean Section: a Retrospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04808375
• Other study ID #: 20210303
• Status: Not yet recruiting
• Start date: March 30, 2021
• Est. completion date: March 30, 2023

Study information

• Verified date: March 2021
• Source: RenJi Hospital
• Contact: Dan Huang, M.S.
• Phone: +8615921108822
• Email: huangdan363[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation

Exclusion Criteria:

• no

Related Conditions & MeSH terms

• Adverse Maternal and Neonatal Outcomes
• Hypertension
• Hypertension, Pregnancy-Induced

Locations

Country	Name	City	State
China	Renji Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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").	42 days after delivery
Primary	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").	42 days after delivery