Clinical Trials Logo

Clinical Trial Summary

Shivering during a cesarean section can be quite uncomfortable for the patient as well as make it difficult for the anesthesiologist to obtain vital signs. The researchers will investigate whether or not applying pressure to the P6 acupressure point during a cesarean section can treat shivering. The hypothesis is that shivering will be alleviated with acupressure.


Clinical Trial Description

The purpose of this study is to determine whether applying pressure to the left and right P6 acupoints can treat shivering in a patient undergoing a cesarean section. The hypothesis is that bilateral stimulation of P6 with pressure can stop or alleviate shivering.

The primary endpoint is resolution of shivering within 15 minutes of applying bilateral pressure to P6 acupoints during a cesarean section.

The secondary endpoints include:

1. Time to resolution of shivering

2. Degree of patient-reported improvement in shivering

3. Degree of practitioner-reported improvement in shivering

4. Assessment of skin irritation and/or pain at the site of acupressure vs control

Patient information will be stored in a locked cabinet on labor and delivery, and that cabinet will be located in a T3-locked office. The link between subject ID and patient ID will be stored in a different office on labor and delivery, also under a T3 lock.

Patients who are laboring with an epidural catheter and subsequently require a cesarean section will be selected. This patient population has a MUCH higher rate of shivering during the cesarean section as compared to patients who undergo elective scheduled cesarean sections under spinal anesthesia. By selecting this group, the investigators are not only increasing chances of identifying shivering but also decreasing variability between patient characteristics by limiting it to one type (only epidural and not spinal) and limiting the number of screen failures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03497507
Study type Interventional
Source Icahn School of Medicine at Mount Sinai
Contact Daniel Katz, MD
Phone (212) 241-7475
Email Daniel.katz@mountsinai.org
Status Recruiting
Phase N/A
Start date January 11, 2018
Completion date December 18, 2018

See also
  Status Clinical Trial Phase
Completed NCT01349686 - Effect of Fluid Oral Intake During Labour N/A
Completed NCT01009411 - Labor Progress Indices and the Dynamics of the Individual Contraction During the Active Stage of Labor N/A
Active, not recruiting NCT02665936 - Effect of Epidural Dexamethasone on Labor Analgesia Phase 2
Completed NCT02839213 - The Effect of Hyoscine Butylbromide on Shortening of First and Second Stages of Labor Phase 2
Recruiting NCT02320279 - The Fetal EKG Study N/A
Completed NCT01099280 - Induction of Labor in Term Premature Rupture of Membranes: A Comparison Between Oxytocin and Dinoprostone Followed Six Hours Later by Oxytocin Phase 3
Completed NCT01052857 - Efficacy of Acupuncture on Induction of Labor Phase 0
Completed NCT00569439 - A Study on the Effects of Dextrose Solutions on the Course of Labor Phase 2
Recruiting NCT01406392 - Sublingual Misoprostol for Induction of Labor Phase 4
Recruiting NCT00827125 - Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based, Multiple Parameters Phase 2
Not yet recruiting NCT02396563 - Effect of Epidural Analgesia on the Length of Labor and Delivery and Fetal Outcomes N/A
Recruiting NCT02539563 - Do Peanut Shaped Birthing Balls Reduce the Length of Labor in Patients With Epidural Analgesia? N/A
Terminated NCT00496899 - Clinical Evaluation of New Computerized Labor Monitoring System N/A
Recruiting NCT03126136 - Pulse Pressure Variability With Position Before EPIdural Analgesia N/A
Completed NCT01157325 - Cesarean Rate in Parturients Without Neuraxial Analgesia N/A
Completed NCT00959920 - Bladder Drainage During Labor: A Randomized Controlled Study of Obstetric Foley Therapy N/A
Completed NCT00665405 - Atelectasis During Delivery - Comparing Cesarian (c) -Section and Labor N/A
Active, not recruiting NCT01916044 - Ultrasound Measure of the Thickness of the Lower Segment in Women Having a History of Caesarian N/A
Completed NCT03138798 - Dental Support Device in the Second Stage of Labor N/A
Not yet recruiting NCT01042483 - Determination of Labor Progression Patterns Using Non-invasive, Ultrasound Based+Continuous Vacuum Mode N/A