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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adverse Maternal and Neonatal Outcomes
• Intervention / Treatment: Other

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Dan Huang, M.S.; Phone Number: +8615921108822; Email: huangdan363@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 30, 2021
• Primary Completion (Anticipated): March 30, 2023
• Study Completion (Anticipated): March 30, 2023

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 20210303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No