Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy

July 20, 2016 updated by: Shinya Ito, The Hospital for Sick Children

A Randomized, Open-Label, Study of Pre-emptive Diclectin® Treatment for Severe Nausea and Vomiting of Pregnancy

The purpose of this study is to determine whether pre-emptive use of a delayed release combination of pyridoxine hydrochloride and doxylamine succinate (Diclectin®), before eruption of symptoms of Nausea and vomiting of pregnancy and hyperemesis gravidarum, will reduce the incidence of severe forms of this syndrome/HG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nausea and vomiting of pregnancy (NVP) affects up to 80% of pregnant women, persists throughout pregnancy in 20% of women. 1%-3% of pregnant women experience the extreme form called hyperemesis gravidarum (HG), described as intractable vomiting associated with weight loss of more than 5% of pre-pregnancy weight, dehydration and electrolyte imbalances which may lead to hospitalization. Treatment involves administration of antiemetics once NVP occurs. Although there is wide evidence of fetal safety of several antiemetic medications, women and health professionals are often reluctant to use antiemetics due to a heightened misperception of teratogenic risk. Diclectin® is a prescription drug in Canada specifically indicated for treatment of NVP. Our preliminary research has shown Diclectin® to be effective for pre-emptive treatment for NVP symptoms in women who experienced severe NVP/HG in their previous pregnancy. This study will evaluate the effectiveness of Diclectin as a pre-emptive treatment for NVP and HG in a randomized controlled trial. In the Pre-emptive Treatment Group, as soon as a patient becomes aware of the present pregnancy, and before the NVP starts, she will take an initial Diclectin® dose, followed by standard dosing to match symptoms once NVP develops. In the Standard Treatment Group women will take Diclectin® only at appearance of symptoms. A natural history control group will also be included. This study will determine whether pre-emptive use of Diclectin will reduce the incidence of severe forms of this syndrome/HG.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy of less than 9 weeks gestation with no symptoms of NVP
  • Not pregnant
  • Include all women with severe NVP/HG in a previous pregnancy regardless of outcome
  • Severe NVP/HG in a previous pregnancy verbally confirmed by the initial recruitment intake questionnaire or previous pregnancy history of NVP/HG section (duration, severity, treatments, and hospitalisation)
  • Verbally agree to participate in the study and send back rhe informed consent form
  • Sufficient French or English language skills to understand the questionnaire and assessment material
  • Women who agree to take Diclectin®
  • Women can enrol with a consecutive pregnancy, if the study is still ongoing

Exclusion Criteria:

  • Women who refuse to participate in the study or to send back the signed consent form
  • Women with insufficient French or English language skills to understand the questionnaire and assessment material
  • Women their first pregnancy and those who havn't suffered severe NVP/HG in previous pregnancy
  • Gestational age beyond 9w+0d weeks of pregnancy
  • Pregnant women who already suffer symptoms of NVP
  • Pregnant women with known hypersensitivities to Diclectin®
  • Women who do not agree to take Diclectin®
  • Women who suffer symptoms of pyelonephritis, thyrotoxicosis, gestational trophoblastic neoplasia
  • Pregnant women less than 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-emptive Treatment Group
As soon as a patient becomes aware of the pregnancy, and before the Nausea and Vomiting of Pregnancy (NVP) starts, she will begin taking Diclectin®. When NVP starts, the dose will be adjusted to match symptoms.
Drug: Diclectin®
Participants will begin with an initial dose of 20mg (2 tablets), taken at bedtime. The dose of Diclectin® will be adjusted to match symptoms.
Active Comparator: Standard Treatment Group
Women randomised to this arm will not receive any Diclectin® before symptoms appear, and will be advised to commence treatment only at first sign of nausea. The starting dose of Diclectin® will be 20mg (2 tablets) at bedtime.
Drug: Diclectin®
Participants will begin with an initial dose of 20mg (2 tablets), taken at bedtime. The dose of Diclectin® will be adjusted to match symptoms.
No Intervention: Natural Course Group
A third group will be randomly matched from Motherisk NVP callers who did not participate in our pre-emptive intervention and experienced severe Nausea and Vomiting of Pregnancy/Hyperemesis Gravidarum (NVP/HG) in their previous pregnancy. This group will serve as a control group for the potential effect of the early counselling. (These women will have called for the first time after NVP symptoms (of any degree) started in the current pregnancy).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of severe NVP (defined by PUQE score >12), or HG (defined by PUQE score >12 plus hospitalization), as compared among the 3 groups.
Time Frame: Follow-up in all groups will be continued monthly until delivery. An additional follow-up telephone interview will be done at approximately 6 months post delivery.
Follow-up in all groups will be continued monthly until delivery. An additional follow-up telephone interview will be done at approximately 6 months post delivery.

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparing the incidence of NVP/HG in present pregnancy with incidence of NVP/HG from the previous pregnancies.
Time Frame: Follow-up in all groups will be continued monthly until delivery. An additional follow-up telephone interview will be done at approximately 6 months post delivery
Follow-up in all groups will be continued monthly until delivery. An additional follow-up telephone interview will be done at approximately 6 months post delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Duchesnay Inc.

Investigators

  • Principal Investigator: Shinya Ito, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000007791

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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