A pragmatic randomised controlled trial of expectant versus surgical management of first trimester spontaneous miscarriage

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2004
INTERVENTION: i. Expectant management ii. Surgical management CONDITION: Pregnancy and childbirth: Pregnancy ; Pregnancy and Childbirth ; Pregnancy PRIMARY OUTCOME: 1. Clinical Outcomes: Complete resolution of pregnancy will be defined as absence of vaginal bleeding and no evidence of products of conception on the ultrasound scan. The attending clinicians will be blind to the treatment received by the patient.; 2. Psychological outcomes. Patients will complete measures of: psychological morbidity (anxiety, depression, somatic symptoms and insomnia) subjective health status, individual quality of life, acceptability and satisfaction with the intervention, adjustment of miscarriage using the Perinatal Grief Scale (Thoedter et al, 1988) SECONDARY OUTCOME: Clinical Outcomes ‐ secondary: ; 1. Completed by the research nurse: blood pressure and temperature, haemoglobin and white cell count. ; 2. Completed by the patient: pain (intensity), bleeding (duration and quantity), convalescence time (days), fertility. INCLUSION CRITERIA: 1. Positive urine pregnancy test 2. Clinical symptoms of miscarriage (vaginal bleeding, lower abdominal pain) 3. Ultrasound evidence of retained placental tissue 4. Gestation age less than 13 weeks 5. Written informed consent given
Epistemonikos ID: 73e85d97104477aeb4d2512a7b2f16814253ed9a
First added on: Aug 21, 2024