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Surgical treatment of placental remnants: hysteroscopic morcellation versus ultrasound guided electric vacuum aspiration, a multicenter randomized controlled trial

Surgical treatment of placental remnants: hysteroscopic morcellation versus ultrasound guided electric vacuum aspiration, a multicenter randomized controlled trial - PLACEMTA: PLAcental remnants CurEttage hysteroscopic Morcellation TriAl

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50222
Enrollment
95
Registered
2014-06-18
Start date
2015-03-02
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

placental remnants or residual trophoblastic tissue

Interventions

Patients are randomized between HM or ultrasound guided EVA. Patients in the observational prospective study will receive the treatment of their choice: HM or ultrasound guided EVA.

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Ultrasonographic findings: image suggestive for placental remnants ranging from 1 to 4 cm in diameter

Exclusion criteria

Exclusion criteria: Placental remnants with a maximum diameter smaller than 1 cm or more than 4 cm Patients presenting with fever Visual or pathological (e.g. on biopsy) evidence of malignancy preoperatively or at the time of operation Untreated cervical stenosis making safe uterine access impossible as diagnosed preoperatively by ambulant hysteroscopy A contra-indication for surgery

Design outcomes

Primary

MeasureTime frame
IUA at follow-up.

Secondary

MeasureTime frame
- Installation and operating time - Conversion rates - Peri- and postoperative complications (e.g. excessive fluid deficit in case of hysteroscopy, perforation, hemorrhage, postoperative infection) - Availability of tissue for pathology analysis and pathology results - Completeness of removal at second look hysteroscopy - Persistence of symptoms - Necessity for additional treatment - Reduction of unnecessary interventions

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)