Ruptured Ectopic PregnancyNCT01932957
Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy
A study testing Laparotomy arm and Laparoscopy arm in people with Ruptured Ectopic Pregnancy, run by University of Pretoria at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ruptured Ectopic Pregnancy
- What is being tested?
- Laparotomy arm and Laparoscopy arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSouth Africa
- Study dates
- 2 May 2012to 30 Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <18 years
- haemodynamically unstable
- not able to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY
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
Read the 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.
- Conditions
- Ruptured Ectopic Pregnancy
- Being tested
- Laparotomy arm, Laparoscopy arm
- Keywords
- Laparoscopy, Ruptured ectopic pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparotomy armProcedure or surgery
Laparotomy as standard treatment for ruptured ectopic pregnancy
Laparoscopy armProcedure or surgery
Laparoscopy as treatment for ruptured ectopic pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Laparotomy arm | Other | Standard treatment Receives: Procedure: Laparotomy arm |
| Laparoscopy arm | Experimental | Treatment by laparoscopy Receives: Procedure: Laparoscopy arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
Hospital stay will be compared between the two groups
Measured: 5 days
Secondary outcomes (2)
Pain scores
Pain scores b means of visual analog pain scale
Measured: 24 hours
Theatre time
Theatre times will be measured and compared for the two groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study start2 May 2012
- Primary completion31 Oct 2013
- Study completion30 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ruptured Ectopic PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pretoria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Snyman, University of Pretoria
- Investigators
- Leon C Snyman, MBChB FCOG, Principal investigator, Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932957
- Sponsor's protocol ID
- Ectopic Trial
- Status last verified
- Mar 2021
- First submitted
- 27 Aug 2013
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY
- ClinicalTrials.gov ID
- NCT01932957
- Acronym / sponsor ID
- Ectopic Trial
- Conditions
- Ruptured Ectopic Pregnancy
- Keywords
- Laparoscopy, Ruptured ectopic pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of PretoriaUniversity, hospital or other
- Study start
- 2 May 2012 (actual)
- Primary completion
- 31 Oct 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparotomy arm | Other | Procedure: Laparotomy armStandard treatment |
| Laparoscopy arm | Experimental | Procedure: Laparoscopy armTreatment by laparoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- <18 years
- haemodynamically unstable
- not able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparotomy armLaparotomy as standard treatment for ruptured ectopic pregnancy | Procedure or surgery | Laparotomy arm |
| Laparoscopy armLaparoscopy as treatment for ruptured ectopic pregnancy | Procedure or surgery | Laparoscopy arm |
Primary outcome
Hospital stay
Time frame: 5 days
Hospital stay will be compared between the two groups
2 secondary outcomes
Pain scores
Time frame: 24 hours
Theatre time
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon C Snyman, MBChB FCOG principal investigator
Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparotomy arm and Laparoscopy arm in people with Ruptured Ectopic Pregnancy, run by University of Pretoria at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital stay (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.