Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery

NCT02718924 | Completed

• 1 other identifier: ch23031401
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators hypothesized that the impact of surgery in terms of inducing a hypercoagulable state is more evident in morbidly obese pregnant women as opposed to their non-obese counterparts. The aim of this study is to investigate the change in coagulation status of morbidly obese and non-obese pregnant women following cesarean section delivery using thromboelastometry. This observational study would also make it possible to calculate the sample size for a future prospective controlled clinical trial to compare the incidence of Hypercoagulability in morbidly obese parturients as opposed to their non-obese counterparts. To the best of our knowledge, no other work has been done any in this area.

Conditions

Pregnancy; Obesity; Hypercoagulability

Keywords

Thromboelastometry; pregnancy; obesity

Outcome Measures

Primary Outcomes (1)

• Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM)

  "G" value will be calculated according to the formula: (5000xMCF)/100-MCF and expressed as dynes/cm2

  8 hours

Secondary Outcomes (5)

• EXTEM clotting time and clot formation time in seconds.

  8 hours

• EXTEM maximum clot firmness in millimeters

  8 hours

• INTEM clotting time and clot formation time in seconds.

  8 hours

• INTEM maximum clot firmness in millimeters

  8 hours

• FIBTEM maximum clot firmness in millimeters

  8 hours

Study Arms (2)

morbidly obese pregnant

Term pregnant women with BMI more than 40

non obese pregnant

Term pregnant women with BMI less than 30

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Term pregnant women presenting for elective cesarean section under spinal anaesthesia

You may qualify if:

• pregnant women at term presenting for cesarean section under spinal anaesthesia with BMI less than 30 and more than 40

You may not qualify if:

• Patients with BMI between 30 and 40 BMI
• Patients with a history of past or current thromboembolism.
• Patients with history of liver disease and those on anticoagulant/anti-platelet therapy
• Patients who requires perioperative blood transfusion
• Patients having General anaesthesia

Sponsors & Collaborators

• Corniche Hospital: lead

Study Sites (1)

Corniche Hospital

Abu Dhabi, 3788, United Arab Emirates

Location

MeSH Terms

Conditions

Obesity; Thrombophilia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mohamed Samy Abdel Raheem, FRCA

  Consultant Anaesthetist

  PRINCIPAL INVESTIGATOR

• Tarek Ansari, FFARCSI

  Consultant Anaesthetist

  PRINCIPAL INVESTIGATOR

• Waleed Riad, MD

  Consultant Anaesthetist

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 17, 2016
• First Posted: March 24, 2016
• Study Start: November 15, 2016
• Primary Completion: September 30, 2017
• Study Completion: October 30, 2017
• Last Updated: November 8, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)