Pregnancy ComplicationsOUTSET-1NCT03439956
Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy
An observational study of Pregnancy Complications and Delivery;Abnormal;Stillbirth, run by Università degli Studi dell'Insubria.
Trial summary
One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions. This step should ensure the complete retrieval of the surgical specimen with concomitant preservation of its integrity (if possible) in order to avoid intraabdominal… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy Complications, Delivery;Abnormal;Stillbirth
- What is being tested?
- Transvaginal specimen extraction
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Apr 2024
- Phase
- Observational
- 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 to 35 years
- Women only
- Adult
Study population: Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction (cases) and pregnant women that did not.
Who may be able to join
- Pregnancy
Who cannot join
- Any pre-existent cause of high risk for adverse obstetric outcomes.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy
One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions. This step should ensure the complete retrieval of the surgical specimen with concomitant preservation of its integrity (if possible) in order to avoid intraabdominal contamination of potentially infected or malignant tissues. Possibilities for specimen extraction during laparoscopy include minilaparotomy, enlargement of an ancillary port, transumbilical extraction, and transvaginal extraction through posterior colpotomy.
Although recent evidence has already suggested that transvaginal extraction through posterior colpotomy is a safe and feasible option, to date there are no published data about obstetric outcomes after this procedure.
For this reason, the current study aims to evaluate obstetric outcomes between women that underwent transvaginal specimen extraction through posterior colpotomy and women who did not.
- Being tested
- Transvaginal specimen extraction
- Keywords
- Obstetric outcomes, Transvaginal specimen extraction, Gynecological laparoscopy
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal specimen extractionProcedure or surgery
Previous transvaginal specimen extraction through posterior colpotomy.
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal specimen extraction (cases) | Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction. Receives: Procedure: Transvaginal specimen extraction | |
| Controls | Pregnant women that did not undergo previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean sections
Percentage of cesarean sections
Measured: During the whole study period (2 years).
Secondary outcomes (3)
Operative deliveries
Percentage of operative deliveries
Measured: During the whole study period (2 years).
Gestational age at deliveries
Gestational age at the moment of delivery.
Measured: During the whole study period (2 years).
Pregnancy complications
Percentages of complications occurring during pregnancies.
Measured: During the whole study period (2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start1 Apr 2022 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy ComplicationsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Simone Laganà, Università degli Studi dell'Insubria
- Investigators
- Antonio Simone Laganà, M.D., Principal investigator, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439956
- Sponsor's protocol ID
- OUTSET-1
- Acronym
- OUTSET-1
- Status last verified
- Sep 2021
- First submitted
- 13 Feb 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy
- ClinicalTrials.gov ID
- NCT03439956
- Acronym / sponsor ID
- OUTSET-1 / OUTSET-1
- Keywords
- Obstetric outcomes, Transvaginal specimen extraction, Gynecological laparoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 20 Feb 2018 (actual)
- 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.
One of the most important downsides of endoscopic surgery is the need to remove surgical specimens of different sizes through very small incisions. This step should ensure the complete retrieval of the surgical specimen with concomitant preservation of its integrity (if possible) in order to avoid intraabdominal contamination of potentially infected or malignant tissues. Possibilities for specimen extraction during laparoscopy include minilaparotomy, enlargement of an ancillary port, transumbilical extraction, and transvaginal extraction through posterior colpotomy.
Although recent evidence has already suggested that transvaginal extraction through posterior colpotomy is a safe and feasible option, to date there are no published data about obstetric outcomes after this procedure.
For this reason, the current study aims to evaluate obstetric outcomes between women that underwent transvaginal specimen extraction through posterior colpotomy and women who did not.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal specimen extraction (cases) | – | Procedure: Transvaginal specimen extractionPregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction. |
| Controls | – | –Pregnant women that did not undergo previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction (cases) and pregnant women that did not.
Key inclusion criteria (1 listed)
- Pregnancy
Key exclusion criteria (1 listed)
- Any pre-existent cause of high risk for adverse obstetric outcomes.
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 |
|---|---|---|
| Transvaginal specimen extractionPrevious transvaginal specimen extraction through posterior colpotomy. | Procedure or surgery | Transvaginal specimen extraction (cases) |
Primary outcome
Cesarean sections
Time frame: During the whole study period (2 years).
Percentage of cesarean sections
3 secondary outcomes
Operative deliveries
Time frame: During the whole study period (2 years).
Gestational age at deliveries
Time frame: During the whole study period (2 years).
Pregnancy complications
Time frame: During the whole study period (2 years).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Antonio Simone Laganà, M.D. principal investigator
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Delivery;Abnormal;Stillbirth, run by Università degli Studi dell'Insubria.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonio Simone Laganà, M.D. (3296279579 ext. +39, antoniosimone.lagana@asst-settelaghi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean sections (time frame: During the whole study period (2 years).). 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 30 Sep 2021.