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

Completed

• Conditions: Pregnancy and childbirth: Pregnancy; Pregnancy and Childbirth; Pregnancy

• Registration Number: ISRCTN21348449
• Lead Sponsor: HS R&D Regional Programme Register - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 0

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

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Measures

Name	Time	Method
Clinical Outcomes - secondary: <br>1. Completed by the research nurse: blood pressure and temperature, haemoglobin and white cell count. <br>2. Completed by the patient: pain (intensity), bleeding (duration and quantity), convalescence time (days), fertility.