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Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

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ClinicalTrials.gov Identifier: NCT01932957
Recruitment Status : Unknown
Verified August 2013 by Leon Snyman, University of Pretoria.
Recruitment status was:  Recruiting
First Posted : August 30, 2013
Last Update Posted : August 30, 2013
Information provided by (Responsible Party):
Leon Snyman, University of Pretoria

Brief Summary:

Standard management for patients with ruptured ectopic pregnancies at our institution is treatment by laparotomy. This trail will investigate the feasibility of treatment with laparoscopy and will look at outcomes such as hospital stay and pain experienced

The hypothesis is that laparoscopy is a feasible treatment option associated with shorter hospital stay and less pain

Condition or disease Intervention/treatment Phase
Ruptured Ectopic Pregnancy Procedure: Laparotomy arm Procedure: Laparoscopy arm Phase 4

Detailed Description:

Laparoscopic surgery for the surgical management of women diagnosed with ectopic pregnancies has become the standard of care in many institutions around the world. Laparotomy is still the standard of care at Kalafong Hospital. There is very little high quality evidence with regard to the optimal surgical management approach for women with ruptured ectopic pregnancies.

The study aims to compare laparotomy with laparoscopy in this group of women with regards to outcomes such as length of hospital stay, number of days off work and pain.

This randomised study will be conducted at Kalafong hospital, on 140 patients diagnosed with ruptured ectopic pregnancy who are haemodynamically stable and are able and willing to provide informed consent.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Laparotomy arm
Standard treatment
Procedure: Laparotomy arm
Laparotomy as standard treatment for ruptured ectopic pregnancy
Experimental: Laparoscopy arm
Treatment by laparoscopy
Procedure: Laparoscopy arm
Laparoscopy as treatment for ruptured ectopic pregnancy

Primary Outcome Measures :
  1. Hospital stay [ Time Frame: 5 days ]
    Hospital stay will be compared between the two groups

Secondary Outcome Measures :
  1. Pain scores [ Time Frame: 24 hours ]
    Pain scores b means of visual analog pain scale

  2. Theatre time [ Time Frame: 1 day ]
    Theatre times will be measured and compared for the two groups

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age >18 years
  • Able to give informed consent
  • must have two of the following three:
  • systolic blood pressure >90 mmHg
  • pulse rate <100 beats per minute
  • heamoglobin >8 g/dL

Exclusion Criteria:

  • <18 years
  • haemodynamically unstable
  • not able to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932957

Contact: Leon C Snyman, MBChB FCOG +27834621818 leon.snyman@up.ac.za
Contact: Takalani Makalani, MBChB +27829443668 tmakulana@yahoo.com

South Africa
Kalafong Academic Hospital Recruiting
Pretoria, Gauteng, South Africa, 0001
Contact: Leon C Snyman, MBChB, MPraxMed, MMed(O&G)    +27834621818    leon.snyman@up.ac.za   
Principal Investigator: Leon C Snyman, MBChB, MPraxMed, MMed, FCOG         
Sub-Investigator: Takalani Makulana, MBChB         
Sponsors and Collaborators
University of Pretoria
Principal Investigator: Leon C Snyman, MBChB FCOG Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria

Responsible Party: Leon Snyman, Professor, University of Pretoria
ClinicalTrials.gov Identifier: NCT01932957     History of Changes
Other Study ID Numbers: Ectopic Trial
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: August 30, 2013
Last Verified: August 2013

Keywords provided by Leon Snyman, University of Pretoria:
Ruptured ectopic pregnancy

Additional relevant MeSH terms:
Cardiac Complexes, Premature
Pregnancy, Ectopic
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Wounds and Injuries
Pregnancy Complications