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Accupressure of P6 to Reduce Nausea During Cesarean Section

Primary Purpose

Pregnancy Related, Cesarean Delivery, Nausea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnet at P6
Magnet applied to arm not at P6 pressure point.
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Related focused on measuring Accupressure, Cesarean Delivery, Nausea, Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥18 years of age
  • English-speaking
  • Pregnant patients presenting for scheduled cesarean delivery of a full-term fetus (>37 weeks' gestation)
  • Patients scheduled as ERAC
  • Parturients undergoing spinal anesthesia

Exclusion Criteria:

  • Patients requiring emergent delivery,
  • Fetal demise
  • Patients with adhesive allergy/sensitivity
  • Patients with allergy/sensitivity to nickel,
  • Patients with inability to consent,
  • Patients with known abnormal placentation
  • Patients with pacemakers/defibrillators
  • Patients with positive COVID-19 tests

Sites / Locations

  • Northwestern Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

P6 Accupressure Group

Sham Pressure Point

Arm Description

The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.

The sham pressure point (distal to the P6 acupressure point).

Outcomes

Primary Outcome Measures

Presence of emesis during scheduled cesarean delivery
Presence of emesis during the scheduled cesarean delivery

Secondary Outcome Measures

Presence of nausea during scheduled cesarean delivery
The presence of nausea during the scheduled cesarean delivery.
presence of nausea after scheduled cesarean delivery
The presence of nausea after scheduled cesarean delivery
Maternal satisfaction of the IONV/PONV management using a VAS
Maternal satisfaction with IONV/PONV medical management using a sliding VAS (visual analog scale) of 0 representing poor satisfaction and 10 representing greatest level of satisfaction. The maternal satisfaction with intraoperative and postoperative nausea and vomiting management.
Number of antiemetic rescue medications given during the intraoperative period
Total number of additional antiemetic rescue medications given during the intraoperative period.
Number of additional antiemetic rescue medications given postoperatively
Total number of number of additional antiemetic rescue medications given during the post operative period.

Full Information

First Posted
February 26, 2021
Last Updated
January 18, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04799587
Brief Title
Accupressure of P6 to Reduce Nausea During Cesarean Section
Official Title
The Use of P6 Acupressure for the Reduction of Intraoperative and Postoperative Nausea and Vomiting in Women Undergoing Cesarean Delivery: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
May 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate if the addition of P6 pressure point stimulation as opposed to sham-point stimulation will decrease intraoperative and postoperative nausea and vomiting (IONV and PONV) for patients undergoing non-emergent cesarean delivery. We hypothesize that the addition of stimulation of the P6 pressure point to our institutional current standard of care (phenylephrine infusion, intravenous fluid bolus, and as needed intraoperative ondansetron) will decrease the occurrence of intraoperative emesis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related, Cesarean Delivery, Nausea, Vomiting
Keywords
Accupressure, Cesarean Delivery, Nausea, Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two group, sham vs actual location of pressure point.
Masking
Participant
Masking Description
Participant will not know whether the pressure point is correct or sham location.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P6 Accupressure Group
Arm Type
Active Comparator
Arm Description
The pressure point will be stimulated by the presence of the magnet when positioned properly on the P6 acupressure point. Additional pressure may be applied as desired by the study subject but is not necessary for P6 stimulation.
Arm Title
Sham Pressure Point
Arm Type
Sham Comparator
Arm Description
The sham pressure point (distal to the P6 acupressure point).
Intervention Type
Other
Intervention Name(s)
Magnet at P6
Intervention Description
Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
Intervention Type
Other
Intervention Name(s)
Magnet applied to arm not at P6 pressure point.
Intervention Description
Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
Primary Outcome Measure Information:
Title
Presence of emesis during scheduled cesarean delivery
Description
Presence of emesis during the scheduled cesarean delivery
Time Frame
Delivery of baby
Secondary Outcome Measure Information:
Title
Presence of nausea during scheduled cesarean delivery
Description
The presence of nausea during the scheduled cesarean delivery.
Time Frame
Delivery of baby
Title
presence of nausea after scheduled cesarean delivery
Description
The presence of nausea after scheduled cesarean delivery
Time Frame
48 hours after delivery of baby
Title
Maternal satisfaction of the IONV/PONV management using a VAS
Description
Maternal satisfaction with IONV/PONV medical management using a sliding VAS (visual analog scale) of 0 representing poor satisfaction and 10 representing greatest level of satisfaction. The maternal satisfaction with intraoperative and postoperative nausea and vomiting management.
Time Frame
48 hours after delivery of baby
Title
Number of antiemetic rescue medications given during the intraoperative period
Description
Total number of additional antiemetic rescue medications given during the intraoperative period.
Time Frame
End of surgery
Title
Number of additional antiemetic rescue medications given postoperatively
Description
Total number of number of additional antiemetic rescue medications given during the post operative period.
Time Frame
48 hours after surgery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnancy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥18 years of age English-speaking Pregnant patients presenting for scheduled cesarean delivery of a full-term fetus (>37 weeks' gestation) Patients scheduled as ERAC Parturients undergoing spinal anesthesia Exclusion Criteria: Patients requiring emergent delivery, Fetal demise Patients with adhesive allergy/sensitivity Patients with allergy/sensitivity to nickel, Patients with inability to consent, Patients with known abnormal placentation Patients with pacemakers/defibrillators Patients with positive COVID-19 tests
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feyce Peralta, MD
Phone
312-472-3585
Email
feyce.peralta@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Fitzgerald, RN, BSN,MS
Phone
312-695-1064
Email
p-fitzgerald2@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feyce Peralta, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feyce Peralta, MD
Phone
312-472-3585
Email
feyce.peralta@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15935649
Citation
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Results Reference
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28976555
Citation
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Results Reference
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PubMed Identifier
16492848
Citation
Ho CM, Tsai HJ, Chan KH, Tsai SK. P6 acupressure does not prevent emesis during spinal anesthesia for cesarean delivery. Anesth Analg. 2006 Mar;102(3):900-3. doi: 10.1213/01.ane.0000195553.82409.00.
Results Reference
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PubMed Identifier
29696109
Citation
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Results Reference
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PubMed Identifier
19370583
Citation
Lee A, Fan LT. Stimulation of the wrist acupuncture point P6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD003281. doi: 10.1002/14651858.CD003281.pub3.
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PubMed Identifier
26348534
Citation
Matthews A, Haas DM, O'Mathuna DP, Dowswell T. Interventions for nausea and vomiting in early pregnancy. Cochrane Database Syst Rev. 2015 Sep 8;2015(9):CD007575. doi: 10.1002/14651858.CD007575.pub4.
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PubMed Identifier
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Citation
Allen TK, Habib AS. P6 stimulation for the prevention of nausea and vomiting associated with cesarean delivery under neuraxial anesthesia: a systematic review of randomized controlled trials. Anesth Analg. 2008 Oct;107(4):1308-12. doi: 10.1213/ane.0b013e31816d1864.
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PubMed Identifier
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Results Reference
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Accupressure of P6 to Reduce Nausea During Cesarean Section

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