Accupressure of P6 to Reduce Nausea During Cesarean Section

Not Applicable

Completed

• Conditions: Pregnancy Related; Cesarean Delivery; Vomiting; Nausea
• Interventions: Other: Magnet at P6; Other: Magnet applied to arm not at P6 pressure point.

• Registration Number: NCT04799587
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-16
• Study Start: 2021-05-26
• Primary Completion: 2023-08-31
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P6 Accupressure Group	Magnet at P6	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.
Sham Pressure Point	Magnet applied to arm not at P6 pressure point.	The sham pressure point (distal to the P6 acupressure point).

Primary Outcome Measures

Name	Time	Method
Presence of emesis during scheduled cesarean delivery	Delivery of baby	Presence of emesis during the scheduled cesarean delivery

Secondary Outcome Measures

Name	Time	Method
Presence of nausea during scheduled cesarean delivery	Delivery of baby	The presence of nausea during the scheduled cesarean delivery.
presence of nausea after scheduled cesarean delivery	48 hours after delivery of baby	The presence of nausea after scheduled cesarean delivery
Maternal satisfaction of the IONV/PONV management using a VAS	48 hours after delivery of baby	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	End of surgery	Total number of additional antiemetic rescue medications given during the intraoperative period.
Number of additional antiemetic rescue medications given postoperatively	48 hours after surgery	Total number of number of additional antiemetic rescue medications given during the post operative period.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States