An interventional study of Laparotomy arm and Laparoscopy arm in Ruptured Ectopic Pregnancy, sponsored by University of Pretoria. Completed at 1 site in South Africa. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by University of Pretoria · Not applicable, Interventional, and Treatment
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
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 140 is above the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →University of Pretoria is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard treatment
Procedure: Laparotomy arm
Treatment by laparoscopy
Procedure: Laparoscopy arm
Laparotomy as standard treatment for ruptured ectopic pregnancy
Laparoscopy as treatment for ruptured ectopic pregnancy
Hospital stay
Hospital stay will be compared between the two groups
Time frame: 5 days
Pain scores
Pain scores b means of visual analog pain scale
Time frame: 24 hours
Theatre time
Theatre times will be measured and compared for the two groups
Time frame: 1 day
Ran from May 2012 to primary completion in Oct 2013, 17 months.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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University of Pretoria