Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy

NCT00293644 | Completed Phase 3

• 1 other identifier: 1000007791
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperemesis Gravidarum; Pregnancy

Keywords

Pregnancy Complications; Hyperemesis Gravidarum; Diclectin; doxylamine succinate; pyridoxine hydrochloride

Outcome Measures

Primary Outcomes (1)

• Rate of severe NVP (defined by PUQE score >12), or HG (defined by PUQE score >12 plus hospitalization), as compared among the 3 groups.

  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 Outcomes (1)

• Comparing the incidence of NVP/HG in present pregnancy with incidence of NVP/HG from the previous pregnancies.

  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

Study Arms (3)

Pre-emptive Treatment Group

EXPERIMENTAL

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®

Standard Treatment Group

ACTIVE COMPARATOR

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®

Natural Course Group

NO INTERVENTION

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).

Interventions

Diclectin® DRUG

Participants will begin with an initial dose of 20mg (2 tablets), taken at bedtime. The dose of Diclectin® will be adjusted to match symptoms.

Pre-emptive Treatment Group; Standard Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Duchesnay Inc.: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Links

• Preemptive treatment of nausea and vomiting of pregnancy: results of a randomized controlled trial.

MeSH Terms

Conditions

Hyperemesis Gravidarum; Pregnancy Complications

Interventions

dicyclomine, doxylamine, pyridoxine drug combination

Condition Hierarchy (Ancestors)

Morning Sickness; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shinya Ito, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Clinical Pharmacology and Toxicology

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 17, 2006
• Study Start: February 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2015
• Last Updated: July 22, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)