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Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Primary Purpose

Nausea, Pain

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Prophylactic use of ibuprofen and ondansetron post misoprostol administration
Use of ibuprofen and ondansetron at symptom onset post misoprostol administration
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring medical abortion, prophylactic use, nausea, pain, patient satisfaction

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Healthy English speaking female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion Gestational age </= 70 days confirmed via ultrasound Access to a time keeping device Willingness to complete a telephone or in-clinic follow up Exclusion Criteria: chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage Failed medical abortion resulting in surgical management Known intrauterine infection Known allergy to ondansetron or ibuprofen Subjects chronically receiving analgesic drugs Subjects unable to give consent Subjects taking medications that interact with ondansetron or ibuprofen

Sites / Locations

  • Antonia OladipoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of care

Prophylactic use

Arm Description

Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.

Administration of ibuprofen and ondansetron at the time of misoprostol administration.

Outcomes

Primary Outcome Measures

Patient satisfaction
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction thereby creating a more favorable outcome. Patient satisfaction will be assessed using a home developed survey. Satisfaction is measured on 5-Likert scale ranging from Very satisfied to Very dissatisfied.
Patient satisfaction based on recommendation of regimen
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction based on their likelihood to recommend the regimen. Likelihood to recommend will be assessed using a home developed survey measured on 5-Likert scale ranging from "Extremely likely to recommend" to "Extremely unlikely to recommend" (an additional "I do not know option" will be provided).

Secondary Outcome Measures

Pain management at 6-8 hours
Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being "no pain" and 10 being "very much pain".
Pain management at 24 hours
Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being "no pain" and 10 being "very much pain".
Nausea Management
Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being "no nausea" and 10 being "very much nausea".
Nausea Management
Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being "no nausea" and 10 being "very much nausea".
Need for pain management medication.
Evaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No).
Need for anti-nausea medication.
Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).

Full Information

First Posted
March 15, 2023
Last Updated
July 21, 2023
Sponsor
Hackensack Meridian Health
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1. Study Identification

Unique Protocol Identification Number
NCT05819619
Brief Title
Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
Official Title
Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
July 19, 2025 (Anticipated)
Study Completion Date
July 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized trial which will aim to evaluate whether prophylactic use of ondansetron and ibuprofen will decrease side effects associated with medical abortion and increase patient satisfaction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Pain
Keywords
medical abortion, prophylactic use, nausea, pain, patient satisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
Arm Title
Prophylactic use
Arm Type
Experimental
Arm Description
Administration of ibuprofen and ondansetron at the time of misoprostol administration.
Intervention Type
Drug
Intervention Name(s)
Prophylactic use of ibuprofen and ondansetron post misoprostol administration
Intervention Description
Prophylactic use of ibuprofen and ondansetron post misoprostol administration
Intervention Type
Drug
Intervention Name(s)
Use of ibuprofen and ondansetron at symptom onset post misoprostol administration
Intervention Description
Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction thereby creating a more favorable outcome. Patient satisfaction will be assessed using a home developed survey. Satisfaction is measured on 5-Likert scale ranging from Very satisfied to Very dissatisfied.
Time Frame
At follow up visit, within 2 weeks from the administration of misoprostol
Title
Patient satisfaction based on recommendation of regimen
Description
Determine if prophylactic use of ondansetron and ibuprofen during medical abortion treatment can increase patient satisfaction based on their likelihood to recommend the regimen. Likelihood to recommend will be assessed using a home developed survey measured on 5-Likert scale ranging from "Extremely likely to recommend" to "Extremely unlikely to recommend" (an additional "I do not know option" will be provided).
Time Frame
At follow up visit, within 2 weeks from the administration of misoprostol
Secondary Outcome Measure Information:
Title
Pain management at 6-8 hours
Description
Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being "no pain" and 10 being "very much pain".
Time Frame
Within 6-8 hours from the administration of misoprostol
Title
Pain management at 24 hours
Description
Evaluate for a satisfactory pain management regimen for medical abortion using a numerical pain scale ranging from 1 to 10 with 1 being "no pain" and 10 being "very much pain".
Time Frame
Within 24 hours from the administration of misoprostol
Title
Nausea Management
Description
Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being "no nausea" and 10 being "very much nausea".
Time Frame
Within 6-8 hours from the administration of misoprostol
Title
Nausea Management
Description
Evaluate for a satisfactory anti-nausea management regimen for medical abortion using a numerical nausea scale ranging from 1 to 10 with 1 being "no nausea" and 10 being "very much nausea".
Time Frame
Within 24 hours from the administration of misoprostol
Title
Need for pain management medication.
Description
Evaluate for a satisfactory pain management regimen for medical abortion based on the need for additional pain medication (Yes vs. No).
Time Frame
Within 24 hours from the administration of misoprostol
Title
Need for anti-nausea medication.
Description
Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).
Time Frame
Within 24 hours from the administration of misoprostol

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy English speaking female volunteers undergoing medical abortion whether for voluntary interruption of pregnancy or missed abortion Gestational age </= 70 days confirmed via ultrasound Access to a time keeping device Willingness to complete a telephone or in-clinic follow up Exclusion Criteria: chronic medical problems including but not limited to cardiac conditions, malignancy or organ damage Failed medical abortion resulting in surgical management Known intrauterine infection Known allergy to ondansetron or ibuprofen Subjects chronically receiving analgesic drugs Subjects unable to give consent Subjects taking medications that interact with ondansetron or ibuprofen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia Oladipo, MD
Phone
5519962765
Email
antonia.oladipo@hmhn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Figueroa, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antonia Oladipo
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonia Oladipo
Phone
551-996-2765
Email
antonia.oladipo@hmhn.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

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