Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful ? - Full Text View

Sponsored by:	Asker & Baerum Hospital
Information provided by:	Asker & Baerum Hospital
ClinicalTrials.gov Identifier:	NCT00540748

Purpose

This is a randomized single blind study using oxytocin 5U i.v. during surgical abortion in one arm of the study, and no medication in the other arm of the study. Comparison is done between the two groups measuring the following outcomes: pain, nausea and bloodloss. Our hypothesis is that there will be no significant differences between the two groups.

Condition	Intervention
First Trimester Abortion	Drug: oxytocin

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Oxytocin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Is Oxytocin Given During Surgical Procedure for Abortion Before 12 Weeks of Pregnancy Useful ?

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:

bloodloss, pain, nausea [ Time Frame: 2 years ]

Estimated Enrollment:	400
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2009

Arms	Assigned Interventions
A1: Experimental	Drug: oxytocin 5 U i.v. during surgical abortion Drug: oxytocin 5 U i.v. during surgery
A2: No Intervention

Detailed Description:

All women seeking surgical abortion before 12 weeks of pregnancy will be invited to participate in the study. We will include 400 patients. Written concent is given. Pain is measured on a VAS-scale (1-10) 2 hours post operatively and repeated 2 days postoperatively. Nausea is categorized in 4 groups, from 1 (no nausea) to 4 (pronounced nausea with vomiting)and is registered together with bloodloss also during the hospital stay (2 hours) and 2 days postoperatively. The two groups will be compared.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

seeking legal abortion
first trimester
surgical intervention
no current medication
fluent in norwegian language

Exclusion Criteria:

Current medication
medical condition with coagulopathy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00540748

Contacts

Contact: Ingerid H Nygaard, consultant, MD	+47 67 80 94 00 ext 2944	ingerid.h.nygaard@sabhf.no
Contact: Annelill Valbo, consultant, MD, PhD	+47 67 80 94 00 ext 9464	annelill.valbo@sabhf.no

Locations

Norway, Baerum
Kvinneklinikken SABHF	Recruiting
RUD, Baerum, Norway, 1309
Contact: Ingerid H Nygaard, MD +47 67 80 94 00 ext 2944 ingerid.h.nygaard@sabhf.no
Contact: Annelill Valbo, MD, PhD +47 67 80 94 00 ext 9464 annelill.valbo@sabhf.no

Sponsors and Collaborators

Asker & Baerum Hospital

Investigators

Study Director:

Annelill Valbo, consultant, MD PhD

Kvinneklinikken SABHF

More Information

Study ID Numbers:	392-06154 1.2006.1683 (REK), 392-06154 1.2006.1683 (REK)
Study First Received:	October 4, 2007
Last Updated:	October 4, 2007
ClinicalTrials.gov Identifier:	NCT00540748
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Medicines Agency; Norway: Norwegian Social Science Data Services

Keywords provided by Asker & Baerum Hospital:

abortion
oxytocin

Study placed in the following topic categories:

Oxytocin

Additional relevant MeSH terms:

Oxytocics
Therapeutic Uses
Physiological Effects of Drugs
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009