Hysteroscopic resection vs dilation and evacuation for treatment of caesarean scar pregnancy: study protocol for a randomised controlled trial.

Background: Caesarean scar pregnancy (CSP) is a type of ectopic pregnancy where the fertilised egg is implanted in the muscle or fibrous tissue of the scar after a previous caesarean section. Management options for women who opted for termination of CSP include sharp curettage, dilation and evacuation (D&E), excision of trophoblastic tissues, local or systemic administration of methotrexate, bilateral hypogastric artery ligation, and selective uterine artery embolisation with curettage and/or methotrexate administration. Recently hysteroscopic resection has also been proposed as an alternative option. Objective: To compare the surgical outcome of hysteroscopic resection with dilation and evacuation (D&E) for the treatment of caesarean scar pregnancy (CSP). Methods: Parallel-group, non-blinded, randomised clinical trial conducted at a single centre in Italy. Eligible women are those with singleton gestations at less than 9 weeks of gestation, and with thickness of myometrial layer ≥1 mm at the level of the ectopic. Inclusion criteria are women with CSP with positive embryonic/fetal heart activity who opted for termination of pregnancy. Patients will be randomised 1:1 to receive either hysteroscopic resection (i.e. intervention group) or D&E (i.e. control group). In both groups, 50 mg/m2 (based on DuBois formula for body surface area) of methotrexate (MTX) will be injected intramuscularly at the time of randomisation (day 1) and another dose at day 3. A third dose of MTX is planned in case of persistence of fetal heart activity on day 5. Participants will receive either D&E or hysteroscopic resection from 3 to 7 days after the last dose of MTX. A sample size of 54 women is planned. Main outcome measures: The primary outcome is the success rate of the treatment protocol, defined as no requirement for further treatment until complete resolution of the CSP as demonstrated by negative beta hCG levels and absence of residual gestational material on ultrasound examination.. Study hypothesis: Hysteroscopic surgery is superior to D&E for the treatment of CSP. What is new?: The results of the trial will provide information on the best treatment for CSP.

Cardiovascular events following pregnancy complicated by pre-eclampsia with emphasis on comparison between early- and late-onset forms: systematic review and meta-analysis.

OBJECTIVE: To elucidate whether pre-eclampsia (PE) and the gestational age at onset of the disease (early- vs late-onset PE) have an impact on the risk of long-term maternal cardiovascular complications. METHODS: MEDLINE, EMBASE and Scopus databases were searched until 15 April 2020 for studies evaluating the incidence of cardiovascular events in women with a history of PE, utilizing combinations of the relevant MeSH terms, keywords and word variants for 'pre-eclampsia', 'cardiovascular disease' and 'outcome'. Inclusion criteria were cohort or case-control design, inclusion of women with a diagnosis of PE at the time of the first pregnancy, and sufficient data to compare each outcome in women with a history of PE vs women with previous normal pregnancy and/or in women with a history of early- vs late-onset PE. The primary outcome was a composite score of maternal cardiovascular morbidity and mortality, including cardiovascular death, major cardiovascular and cerebrovascular events, hypertension, need for antihypertensive therapy, Type-2 diabetes mellitus, dyslipidemia and metabolic syndrome. Secondary outcomes were the individual components of the primary outcome analyzed separately. Data were combined using a random-effects generic inverse variance approach. MOOSE guidelines and the PRISMA statement were followed. RESULTS: Seventy-three studies were included. Women with a history of PE, compared to those with previous normotensive pregnancy, had a higher risk of composite adverse cardiovascular outcome (odds ratio (OR), 2.05 (95% CI, 1.9-2.3)), cardiovascular death (OR, 2.18 (95% CI, 1.8-2.7)), major cardiovascular events (OR, 1.80 (95% CI, 1.6-2.0)), hypertension (OR, 3.93 (95% CI, 3.1-5.0)), need for antihypertensive medication (OR, 4.44 (95% CI, 2.4-8.2)), dyslipidemia (OR, 1.32 (95% CI, 1.3-1.4)), Type-2 diabetes (OR, 2.14 (95% CI, 1.5-3.0)), abnormal renal function (OR, 3.37 (95% CI, 2.3-5.0)) and metabolic syndrome (OR, 4.30 (95% CI, 2.6-7.1)). Importantly, the strength of the associations persisted when considering the interval (< 1, 1-10 or > 10 years) from PE to the occurrence of these outcomes. When stratifying the analysis according to gestational age at onset of PE, women with previous early-onset PE, compared to those with previous late-onset PE, were at higher risk of composite adverse cardiovascular outcome (OR, 1.75 (95% CI, 1.0-3.0)), major cardiovascular events (OR, 5.63 (95% CI, 1.5-21.4)), hypertension (OR, 1.48 (95% CI, 1.3-1.7)), dyslipidemia (OR, 1.51 (95% CI, 1.3-1.8)), abnormal renal function (OR, 1.52 (95% CI, 1.1-2.2)) and metabolic syndrome (OR, 1.66 (95% CI, 1.1-2.5). CONCLUSIONS: Both early- and late-onset PE represent risk factors for maternal adverse cardiovascular events later in life. Early-onset PE is associated with a higher burden of cardiovascular morbidity and mortality compared to late-onset PE. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.