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

Placental remnants can occur following miscarriage, termination of pregnancy
(TOP), after vaginal delivery or cesarean section. Placental remnants are
mainly removed by curettage, however data suggest that hysteroscopic removal
might be superior to curettage regarding completeness of removal, tissue
availability, the risk of development of intrauterine adhesions (IUA) and in
reducing unnecessary interventions. To our knowledge no randomized controlled
trials have been published comparing removal of remnants by hysteroscopic
morcellation (HM) versus curettage.

To compare HM to ultrasound guided electric vacuum aspiration (EVA) for removal
of placental remnants with respect to the risk of IUA formation, and in terms
of efficiency and complications.

Multicenter, randomized controlled trial with prospective follow up of patients
with a placental remnant who do not wish to participate in the randomized
controlled trial

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.

Women who attend our outpatient clinic will be seen on a first visit, and,
according to the standard work-up, an ultrasound will be performed when
placental remnants are suspected. Patients with placental remnants according to
the ultrasonographic inclusion criteria are asked whether they want to take
part in this study after discussion of the different treatment options. After
informed consent, patients are randomized between EVA and HM. Patients who are
randomized for EVA can undergo this procedure as soon as possible, as this is
common practice. Patients in the hysteroscopic treatment arm first undergo an
ambulant diagnostic hysteroscopy at a minimum of 6 weeks after end of pregnancy
to confirm the diagnosis of placental remnants. Upon confirmation a HM
procedure is scheduled approximately 1 week later. At this moment, both
hysteroscopic removal and vacuum aspiration are used in our hospitals and the
choice of treatment depends on the preference of the gynecologist. All women
will be treated in a daycare setting according to the standard of care, only
now randomized between the two techniques. A postoperative visit with second
look hysteroscopy, checking for intrauterine adhesions and completeness of
removal, is scheduled after at least 1 menstruation or a period of minimum 8
weeks after the operation. Late postoperative complications and complaints are
recorded.
Aim of the study is to examine whether HM beholds advantages over ultrasound
guided EVA in terms of a lower risk of IUA formation and more complete removal,
as these often require additional treatment and may influence patient*s future
fertility.
Patients who do not want to participate in the randomized trial are asked
whether they consent with follow-up in the prospective cohort study.