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Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by University of Pretoria.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Leon Snyman, University of Pretoria Identifier:
First received: August 27, 2013
Last updated: NA
Last verified: August 2013
History: No changes posted

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 Intervention Phase
Ruptured Ectopic Pregnancy
Procedure: Laparotomy arm
Procedure: Laparoscopy arm
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by University of Pretoria:

Primary Outcome Measures:
  • Hospital stay [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Hospital stay will be compared between the two groups

Secondary Outcome Measures:
  • Pain scores [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Pain scores b means of visual analog pain scale

  • Theatre time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Theatre times will be measured and compared for the two groups

Estimated Enrollment: 140
Study Start Date: May 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01932957

Contact: Leon C Snyman, MBChB FCOG +27834621818
Contact: Takalani Makalani, MBChB +27829443668

South Africa
Kalafong Academic Hospital Recruiting
Pretoria, Gauteng, South Africa, 0001
Contact: Leon C Snyman, MBChB, MPraxMed, MMed(O&G)    +27834621818   
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
  More Information

Responsible Party: Leon Snyman, Professor, University of Pretoria Identifier: NCT01932957     History of Changes
Other Study ID Numbers: Ectopic Trial 
Study First Received: August 27, 2013
Last Updated: August 27, 2013
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by University of Pretoria:
Ruptured ectopic pregnancy

Additional relevant MeSH terms:
Cardiac Complexes, Premature
Pregnancy, Ectopic
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Pregnancy Complications
Wounds and Injuries processed this record on May 30, 2016