ClinicalTrials.gg
Status unknownNCT03439956OUTSET-1Updated Sep 30, 2021

Obstetric Outcomes After Transvaginal Specimen Extraction in Gynecological Laparoscopy

An observational study in Pregnancy Complications and Delivery;Abnormal;Stillbirth, sponsored by Università degli Studi dell'Insubria. Status unknown. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2021-09-30.

Sponsored by Università degli Studi dell'Insubria · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 35 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Pregnancy Complications
  • Delivery;Abnormal;Stillbirth

Keywords

  • Obstetric outcomes
  • Transvaginal specimen extraction
  • Gynecological laparoscopy
03

In context

Pregnancy Complications

411 studies on the registry are indexed under Pregnancy Complications; 113 are open to participants now.

This study's planned enrollment of 200 is below the median of 400 across 198 observational studies indexed under Pregnancy Complications.

Browse Pregnancy Complications studies →

Lead sponsor

Università degli Studi dell'Insubria is the lead sponsor of 68 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction (cases) and pregnant women that did not.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnancy

Exclusion criteria

Exclusion Criteria:

  • Any pre-existent cause of high risk for adverse obstetric outcomes.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Transvaginal specimen extraction (cases)

    Pregnant women that underwent previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction.

    Procedure: Transvaginal specimen extraction

  • Controls

    Pregnant women that did not undergo previous laparoscopic myomectomy or ovarian cystectomy with transvaginal specimen extraction.

Interventions

  • ProcedureTransvaginal specimen extraction

    Previous transvaginal specimen extraction through posterior colpotomy.

06

What researchers measure

Primary outcomes

  1. Cesarean sections

    Percentage of cesarean sections

    Time frame: During the whole study period (2 years).

Secondary outcomes

  1. Operative deliveries

    Percentage of operative deliveries

    Time frame: During the whole study period (2 years).

  2. Gestational age at deliveries

    Gestational age at the moment of delivery.

    Time frame: During the whole study period (2 years).

  3. Pregnancy complications

    Percentages of complications occurring during pregnancies.

    Time frame: During the whole study period (2 years).

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2022; primary completion for Apr 2023, 12 months later.

Of 113 non-industry observational studies under Pregnancy Complications, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 201. This study's planned 12 months is below that.

Counting every sponsor, half of 121 studies reached it within 60 months; a quarter within 30 and three quarters within 151.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Feb 20, 2018
StartEst.
Apr 1, 2022
Primary completionEst.
Apr 1, 2023
CompletionEst.
Apr 1, 2024
Last update
Sep 30, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 30, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03439956
Lead sponsor
Università degli Studi dell'Insubria
Responsible party
Antonio Simone Laganà (Medical Doctor, Università degli Studi dell'Insubria) — Principal investigator
First posted
Feb 20, 2018
Start date
Apr 1, 2022 (estimated)
Primary completion
Apr 1, 2023 (estimated)
Completion
Apr 1, 2024 (estimated)
Last update
Sep 30, 2021

Study contacts

Antonio Simone Laganà, M.D.
Contact
antoniosimone.lagana@asst-settelaghi.it
3296279579 ext. +39
Antonio Simone Laganà, M.D.
principal investigator · Università degli Studi dell'Insubria

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion