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Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy.

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Duchesnay Inc.
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00293644
First received: February 15, 2006
Last updated: November 19, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Hyperemesis Gravidarum
Pregnancy
Drug: Diclectin®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Open-Label, Study of Pre-emptive Diclectin® Treatment for Severe Nausea and Vomiting of Pregnancy.

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparing the incidence of NVP/HG in present pregnancy with incidence of NVP/HG from the previous pregnancies. [ Time Frame: Follow-upswill be continued monthly until delivery. An additional follow-up telephone interview will be done at approximately 6 months post delivery ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2006
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
After Nausea and Vomiting of Pregnancy (NVP) symptoms start, the starting dose of Diclectin® will be taken at bedtime. The dose of Diclectin® 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293644

Locations
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Duchesnay Inc.
Investigators
Principal Investigator: Gideon Koren, MD The Hospital for Sick Children
  More Information

Additional Information:
No publications provided

Responsible Party: Gideon Koren, Director of MotherRisk Program, Clinical Pharmacology and Toxicology, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00293644     History of Changes
Other Study ID Numbers: 1000007791
Study First Received: February 15, 2006
Last Updated: November 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Pregnancy Complications
Hyperemesis Gravidarum
Diclectin
doxylamine succinate
pyridoxine hydrochloride

Additional relevant MeSH terms:
Hyperemesis Gravidarum
Pregnancy Complications
Vomiting
Morning Sickness
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 20, 2014