retained products of conception retained products of conception
Conditions
Interventions
Office operative hysteroscopy versus expectant management. Patients after a non-surgical management of a miscarriage and wish for immediate (within 6 months) future pregnancy with sonographic evidence
Sponsors
Universitair Ziekenhuis Gent
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Women of 18 years of age and maximum 39 years of age. Women treated non-surgically and non-reassuring sonographic evidence of the absence of RPOC at follow-up visit 6 weeks (± 1 week).Women with immediate future pregnancy wish after first trimester miscarriage after initial non-surgical treatment.Informed consent.
Exclusion criteria
Exclusion criteria: Women aged below 18 years and women aged over 39 years Women not wanting to achieve pregnancy within the first 6 months after non-surgical treatment for miscarriage Women with a history of repeated miscarriage defined as 3 or more consecutive pregnancy losses before 20 weeks of pregnancy duration (Rai 2006, NVOG 2007) Women with untreated and/or untreatable subfertility Women presenting with severe uterine bleeding, defined as uterine bleeding that needs acute intervention on medical grounds Women presenting with severe abdominal pain, defined as abdominal pain that needs acute intervention on medical grounds Women with fever (> 38.5° Celsius) or sepsis requiring antibiotic treatment. For the definition of ‘sepsis’ we refer to the Third International Consensus definitions for Sepsis and Septic Shock (Singer 2016) Women with a contraindication for (office) operative hysteroscopy Women with a failed non-surgical management for miscarriage, as substantiated by the sonographic finding of an intact gestational sac still in situ Women with a congenital uterine anomaly Known cervical stenosis making safe uterine access impossible Visual or pathological (e.g. on biopsy) evidence of malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is time to next pregnancy, as substantiated by a positive urinary or serum hCG test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are Quality of Life (QOL) scores assessed with the SF-36, HADS and EQ-5D-5L, the need for additional and/or unscheduled treatments and/or visits and complications. Furthermore, data on the course of pregnancy - including miscarriage, ectopic pregnancy and live birth – is documented in those women who have an ongoing pregnancy after randomization during the study follow up period. In addition, iMTA PCQ questionnaires and health-costs are measured in all patients to perform a cost-effectiveness analysis. | — |
Countries
Belgium, Netherlands, United Kingdom
Contacts
Public ContactTWO Hamerlynck
UZ Gent
Outcome results
None listed