Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Sponsor

Hackensack Meridian Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05819619

Collaborator

(none)

168

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Pain	Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Prophylactic Analgesic and Antiemetic Regimen for Medical Abortion < 70 Days

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Mar 30, 2025

Anticipated Study Completion Date :

Mar 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of care Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.	Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration Administration of ibuprofen or ondansetron only when experiencing pain or nausea respectively post misoprostol administration.
Experimental: Prophylactic use Administration of ibuprofen and ondansetron at the time of misoprostol administration.	Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Arm

Intervention/Treatment

Active Comparator: Standard of care

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

Drug: Use of ibuprofen and ondansetron at symptom onset post misoprostol administration

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

Experimental: Prophylactic use

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

Drug: Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Prophylactic use of ibuprofen and ondansetron post misoprostol administration

Outcome Measures

Primary Outcome Measures

Patient satisfaction [At follow up visit, within 2 weeks from the administration of misoprostol]
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 [At follow up visit, within 2 weeks from the administration of misoprostol]
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 [Within 6-8 hours from the administration of misoprostol]
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 [Within 24 hours from the administration of misoprostol]
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 [Within 6-8 hours from the administration of misoprostol]
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 [Within 24 hours from the administration of misoprostol]
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. [Within 24 hours from the administration of misoprostol]
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. [Within 24 hours from the administration of misoprostol]
Evaluate for a satisfactory anti-nausea management regimen for medical abortion based on the additional anti-nausea medication (Yes vs. No).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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