Comparing a 'wait and watch' approach vs medical treatment with misoprostol for first trimester retained products of pregnancy and using ultrasound to predict success

Patients with first trimester symptomatic retained products of conception ( RPOC) and proven on transvaginal ultrasound after antecedent events of spontaneous miscarriage, primary medically managed miscarriage, primary dilatation and curettage(D&C) for miscarriage, medical termination of pregnancy and surgical termination of pregnancy with D&C will be randomized to either the control arm (expectant management, i.e., 'wait and watch') or the intervention arm ( medical management with misoprostol) in a 1:1 ratio. The randomization is stratified based on colour doppler scores of the retained tissue on transvaginal ultrasound; i.e., scores 1-4; 1- no vascularity, 2- minimal vascularity, 3- moderate vascularity, 4 - strong vascularity. Intervention arm- Medical management (Group M) – With this method, patients will be advised to self-administer misoprostol 800 mcg (4 tablets of 200 mcg) buccally (2 tablets kept in each cheek until dissolved, not to swallow) as a once only administration. To manage side effects, they will also be prescribed regular oral pantoprazole 40 mg once daily and 4 mg ondansetron wafers three times daily or as needed, oral ibuprofen 400 mg three times daily after meals or as needed, oral paracetamol 1000 mg upto 4 times daily or as needed, and oral panadeine forte 500/30 (2 tabs) upto 4 times daily or as needed for 24 hours. Patients will be counselled about side effects like nausea, vomiting, diarrhoea and strong uterine cramping and will be advised to keep a symptom diary of their side effects. All patients will be advised about alert symptoms that should prompt a presentation to the nearest Emergency department including fever, foul-smelling discharge and heavy bleeding with clots with frequency of changing 1 full soaked pad every hour or less for over 4 hours. Patients from both control and intervention arms will be followed up at 4 weeks ( Interim visit) and 8 weeks ( final visit) with a repeat transvaginal ultrasound at each visit to look for persistent retained products. At either visit, ultrasound findings of an empty uterus with absence of retained products defined as homogenous endometrium with absent vascularity with no measurable focus of hyperechoic material suggesting trophoblastic tissue will be considered successful management. These patients will not require subsequent clinic follow up. The persistence of retained products at 4 weeks will prompt a further follow up at 8 weeks to draw final conclusions. If RPOC is present on transvaginal ultrasound at 8 weeks, non-surgical management is considered unsuccessful and the patient is advised surgical management via hysteroscopic resection or ultrasound guided dilatation and curettage within 1 week. This will be arranged in our centre. All participants will be consented at their baseline visit for a follow up phone call at 6 months to note long term sequelae of non surgical management of RPOC