PregnancyNCT02718924
Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery
An observational study of Pregnancy and Obesity, run by Corniche Hospital at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Obesity, Hypercoagulability
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 15 Nov 2016to 30 Oct 2017
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Term pregnant women presenting for elective cesarean section under spinal anaesthesia
Who may be able to join
- pregnant women at term presenting for cesarean section under spinal anaesthesia with BMI less than 30 and more than 40
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thromboelastometry (ROTEM) For Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery: An Observational Study
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.
Read the detailed description
Following institutional ethical committee approval, 20 morbidly obese (BMI>40) and 20 non-obese (BMI < 30) parturients undergoing elective low segment cesarean section (LSCS) delivery under spinal subarachnoid block will be recruited into the study. A written informed consent will be obtained from all parturients prior to inclusion. All patients will receive an information sheet at the preoperative assessment visit to inform them about this study. Patients with a history of past or current thromboembolism will be excluded from the study as well as those with liver disease and those already on anticoagulant/anti-platelet therapy for repeated miscarriage or other indications. History of thromboembolism is defined as an arterial or deep venous thrombosis, catheter thrombosis, or pulmonary embolism diagnosed by ultrasound or spiral computed tomography (CT). Preoperative baseline full blood count and clotting profile will be done. Parturients with abnormal platelet count or coagulation results and those who will need conversion to general anesthesia will be excluded.
Data and sample collection Preoperative BMI, co-existing morbidities and laboratory test results including INR, PTT and platelet count as well as operative time and postoperative clinical or radiological evidence of thromboembolism will be recorded. A blood sample will be collected for ROTEM analysis prior to establishing the block (baseline), immediately after surgery and 8 hours later.
ROTEM analysis
Coagulability will be assessed using the ROTEM thromboelastometry analyzer (The ROTEM® delta, Tem Systems Inc.®, Munich, Germany). Extrinsic rotational thromboelastometry (EXTEM), intrinsic rotational thromboelastometry (INTEM) and FIBTEM will be measured for each blood sample. Clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF) will be recorded. Total clot strength will be assessed by "G" value as calculated according to the formula: (5000xMCF)/100-MCF and expressed as dynes/cm2 . G has been shown to be valuable in diagnosing hypo- and hypercoagulability . In non-obstetric cohorts, hypercoagulability was defined as a G value of ≥ 11.7 dynes/cm2 and hypocoagulability as a G value of <5.0 dynes/cm2 (values provided by manufacturer).
- Conditions
- Pregnancy, Obesity, Hypercoagulability
- Keywords
- Thromboelastometry, pregnancy, obesity
- Medical subject headings
- Obesity, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| morbidly obese pregnant | Term pregnant women with BMI more than 40 | |
| non obese pregnant | Term pregnant women with BMI less than 30 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 hours
Secondary outcomes (5)
EXTEM clotting time and clot formation time in seconds.
measured ROTEM thromboelastometry variables
Measured: 8 hours
EXTEM maximum clot firmness in millimeters
measured ROTEM thromboelastometry variable
Measured: 8 hours
INTEM clotting time and clot formation time in seconds.
measured ROTEM thromboelastometry variables
Measured: 8 hours
INTEM maximum clot firmness in millimeters
measured ROTEM thromboelastometry variable
Measured: 8 hours
FIBTEM maximum clot firmness in millimeters
measured ROTEM variable
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start15 Nov 2016
- Primary completion30 Sep 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corniche Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Samy Abdel Raheem, FRCA, Principal investigator, Consultant AnaesthetistTarek Ansari, FFARCSI, Principal investigator, Consultant AnaesthetistWaleed Riad, MD, Principal investigator, Consultant Anaesthetist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718924
- Sponsor's protocol ID
- ch23031401
- Status last verified
- Nov 2018
- First submitted
- 17 Jan 2016
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastometry (ROTEM) For Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery: An Observational Study
- ClinicalTrials.gov ID
- NCT02718924
- Acronym / sponsor ID
- ch23031401
- Conditions
- Pregnancy, Obesity, Hypercoagulability
- Keywords
- Thromboelastometry, pregnancy, obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Corniche HospitalUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
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.
Detailed description
Following institutional ethical committee approval, 20 morbidly obese (BMI>40) and 20 non-obese (BMI < 30) parturients undergoing elective low segment cesarean section (LSCS) delivery under spinal subarachnoid block will be recruited into the study. A written informed consent will be obtained from all parturients prior to inclusion. All patients will receive an information sheet at the preoperative assessment visit to inform them about this study. Patients with a history of past or current thromboembolism will be excluded from the study as well as those with liver disease and those already on anticoagulant/anti-platelet therapy for repeated miscarriage or other indications. History of thromboembolism is defined as an arterial or deep venous thrombosis, catheter thrombosis, or pulmonary embolism diagnosed by ultrasound or spiral computed tomography (CT). Preoperative baseline full blood count and clotting profile will be done. Parturients with abnormal platelet count or coagulation results and those who will need conversion to general anesthesia will be excluded.
Data and sample collection Preoperative BMI, co-existing morbidities and laboratory test results including INR, PTT and platelet count as well as operative time and postoperative clinical or radiological evidence of thromboembolism will be recorded. A blood sample will be collected for ROTEM analysis prior to establishing the block (baseline), immediately after surgery and 8 hours later.
ROTEM analysis
Coagulability will be assessed using the ROTEM thromboelastometry analyzer (The ROTEM® delta, Tem Systems Inc.®, Munich, Germany). Extrinsic rotational thromboelastometry (EXTEM), intrinsic rotational thromboelastometry (INTEM) and FIBTEM will be measured for each blood sample. Clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF) will be recorded. Total clot strength will be assessed by "G" value as calculated according to the formula: (5000xMCF)/100-MCF and expressed as dynes/cm2 . G has been shown to be valuable in diagnosing hypo- and hypercoagulability . In non-obstetric cohorts, hypercoagulability was defined as a G value of ≥ 11.7 dynes/cm2 and hypocoagulability as a G value of <5.0 dynes/cm2 (values provided by manufacturer).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morbidly obese pregnant | – | –Term pregnant women with BMI more than 40 |
| non obese pregnant | – | –Term pregnant women with BMI less than 30 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Term pregnant women presenting for elective cesarean section under spinal anaesthesia
Key inclusion criteria (1 listed)
- pregnant women at term presenting for cesarean section under spinal anaesthesia with BMI less than 30 and more than 40
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM)
Time frame: 8 hours
"G" value will be calculated according to the formula: (5000xMCF)/100-MCF and expressed as dynes/cm2
5 secondary outcomes
EXTEM clotting time and clot formation time in seconds.
Time frame: 8 hours
EXTEM maximum clot firmness in millimeters
Time frame: 8 hours
INTEM clotting time and clot formation time in seconds.
Time frame: 8 hours
INTEM maximum clot firmness in millimeters
Time frame: 8 hours
FIBTEM maximum clot firmness in millimeters
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Individual participant dataSharing planned: No. No plan
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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.
Mohamed Samy Abdel Raheem, FRCA principal investigator
Consultant Anaesthetist
Tarek Ansari, FFARCSI principal investigator
Consultant Anaesthetist
Waleed Riad, MD principal investigator
Consultant Anaesthetist
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 Pregnancy and Obesity, run by Corniche Hospital at 1 site in United Arab Emirates.
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 5 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: finished, as of the sponsor's last update on 8 Nov 2018. 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 United Arab Emirates. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculated clot strength using EXTEM Maximum Clot Firmness (G value for EXTEM) (time frame: 8 hours). 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 8 Nov 2018.