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

NCT04808375 | Unknown

• 1 other identifier: 20210303
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adverse Maternal and Neonatal Outcomes

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

Central Study Contacts

Dan Huang, M.S.

CONTACT

+8615921108822; huangdan363@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 22, 2021
• Study Start: March 30, 2021
• Primary Completion: March 30, 2023
• Study Completion: March 30, 2023
• Last Updated: March 22, 2021

Record last verified: 2021-03

Locations

CN (1)