Pregnancy and childbirth: Pregnancy Pregnancy and Childbirth Pregnancy
Conditions
Interventions
i. Expectant management
ii. Surgical management
Sponsors
NHS R&D Regional Programme Register - Department of Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Not provided at time of registration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed