WithdrawnPhase 1/2

Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)

Stopped: transfer of PI to new organization

United States0Started 2022-06-13

Plain-language summary

The primary objective of this proposal is to conduct an early Phase 2 clinical trial to determine the acceptability, dosing, tolerability and safety of mirtazapine for severe nausea and vomiting of pregnancy (sNVP) that is not adequately responsive to current standard treatments. This plan mirrors clinical practice since commonly prescribed antiemetic/ antinauseant drugs will be tested for efficacy before treating with mirtazapine.

Who can participate

Age range18 Years – 49 Years

SexFEMALE

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Inclusion Criteria: * singleton pregnancy * inpatient or outpatient status * English speaking * obstetrician's evaluation and diagnosis of sNVP or HG * tolerance of oral disintegrating tablet at bedtime * PUQE score of 10-15; moderate/high or severe * refractory sNVP * blood pressure range 70-200 / 45-120 * normal ECG Exclusion Criteria: * allergic or adverse reaction to mirtazapine * patient has bipolar disorder * subjects with active depression, or history of or current active suicidal ideation or attempt * subjects with renal or hepatic impairment * substance about in last 6 months * use of medicinal or recreational cannabis-derived products in the last 6 months * taking MAOIs, strong CYP3A inducers or inhibitors, and SSRIs

What they're measuring

change in Pregnancy Unique Quality of Emesis (PUQE) score

Timeframe: daily for three weeks

Trial details

NCT IDNCT05452174

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-29

View on ClinicalTrials.gov More Pregnancy trials