Prevalence And Burden Of Nausea And Vomiting In Pregnant Women

Last updated: September 2, 2021
Sponsor: Italfarmaco
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vomiting

Colic

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT04926727
OPITA/0120/SU
  • Ages > 18
  • Female
  • Accepts Healthy Volunteers

Study Summary

On February 25th, 2019, ITALFARMACO launched Nuperal® in Italy, an association of doxylamine succinate and pyridoxine hydrochloride authorized by AIFA for the symptomatic treatment of nausea and vomiting in pregnancy (NVP). This drug is also recommended as first choice drug therapy by the American College of Obstetricians and Gynecologists (ACOG) Guidelines and is supported by extensive international literature.

Numerous epidemiological researches conducted in the US and Norway have highlighted the extent of vomiting and pregnant nausea. Unfortunately to date, there are no information on the prevalence of this phenomenon in Italy, on its impact on women's lives and on the interaction between woman and gynecologists.

The research hypothesis of the present survey is that, using a representative sample of pregnant women in Italy, it will be possible to identify the prevalence and weight of nausea and vomiting symptoms during pregnancy in this country. The study is an open, non-comparative, multicenter survey and the aim is to evaluate the prevalence and weight that the symptoms of nausea and vomiting have in pregnant women in Italy.

The study population will include 600 women found during weeks 18-22 of pregnancy who will arrive at the three sites or will contact the Investigators after the Ethics Committee (EC) approval.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Caucasian women in physiological pregnancy and between the 18th and 22nd week (time ofmorphological ultrasound).
  • Women able to communicate adequately with the interviewer and understand thequestionnaires.
  • Women able to understand and who can provide valid informed consent to the Survey.

Exclusion

Exclusion Criteria:

  • Twin pregnancy.
  • Medically assisted procreation (MAP)

Study Design

Total Participants: 600
Study Start date:
October 04, 2021
Estimated Completion Date:
May 31, 2022

Connect with a study center

  • Policlinico di Napoli - Università di Napoli "Federico II"

    Napoli, Corso Umberto I 40 80138
    Italy

    Site Not Available

  • P.O. SS.ma Annunziata di Chieti della ASL di Chieti

    Chieti, Via Dei Vestini 66100
    Italy

    Site Not Available

  • Ospedale dei Bambini "Vittore Buzzi"

    Milano, Via Lodovico Castelvetro, 32 20154
    Italy

    Site Not Available

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