Trial Outcomes & Findings for A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective. (NCT NCT02295280)

NCT ID: NCT02295280

Last Updated: 2018-04-02

Results Overview

Number of participants with reduction in pain scores six hours post administration by at least 2 on the pain score scale.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: Primary outcome was six hours post administration
• Results posted on: 2018-04-02

Participant Flow

This was a prospective randomized, controlled trial at a single perinatal care center, conducted from December 2012 through September 2014 and approved by the IRB at Saint Louis University.

Participant milestones

Measure	Metoclopramide IV & Diphenhydramine IV Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV Group A Metoclopramide: IV Diphenhydramine: iv	Codeine Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet. Codeine: PO
Overall Study STARTED	35	35
Overall Study COMPLETED	35	34
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Metoclopramide IV & Diphenhydramine IV Intravenous (IV) access will be obtained and administration of 10mg Metoclopramide IV and 25mg Diphenhydramine IV Group A Metoclopramide: IV Diphenhydramine: iv	Codeine Group B (control group) will receive standard treatment consisting of a codeine 30mg tablet. Codeine: PO
Overall Study Adverse Event	0	1

Baseline Characteristics

A Cost Effective Treatment for Headache in Pregnancy When Acetaminophen Alone is Ineffective.

Baseline characteristics by cohort

Measure	Metoclopramide IV & Diphenhydramine IV n=35 Participants Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache.	Codeine n=34 Participants Normotensive pregnant women in the second or third trimester were randomized to receive either MAD intravenously (10 mg and 25 mg, respectively) or codeine (30 mg) for headache symptoms after 650-1000 mg of acetaminophen failed to relieve the headache.	Total n=69 Participants Total of all reporting groups
Age, Customized <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized Between 18 and 65 years	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Age, Customized >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	23 years n=5 Participants	23.5 years n=7 Participants	23 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	34 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	34 participants n=7 Participants	69 participants n=5 Participants

PRIMARY outcome

Timeframe: Primary outcome was six hours post administration

Population: Number in each arm with data at 6 hours who received either metoclopramide and diphenhydramine IV or codeine.

Number of participants with reduction in pain scores six hours post administration by at least 2 on the pain score scale.

Outcome measures

Measure	Metoclopramide IV & Diphenhydramine IV n=34 Participants Number of patients who received Metoclopramide \& diphenhydramine IV	Codeine n=32 Participants Number of patients who received codeine
Number of Participants With Adequate Relief of Headache as a Measure of Efficacy	34 Participants	32 Participants

Adverse Events

Metoclopramide & Diphenhydramine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Codeine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dorothea Mostello, MD, Maternal Fetal Medicine Faculty

Saint Louis University

Phone: 314-977-2090

Email: mostello@slu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place