A randomised double blind trial comparing misoprostol or placebo in the management of early miscarriage

• Published in: BJOG : an international journal of obstetrics and gynaecology Vol. 112; no. 8; pp. 1090 - 1095
• Main Authors: Blohm, F., Fridén, B.E., Milsom, I., Platz‐Christensen, J.J., Nielsen, S.
• Format: Journal Article
• Language: English
• Published: Oxford, UK and Malden, USA Blackwell Science Ltd 01.08.2005; Blackwell; Wiley Subscription Services, Inc
• Subjects: Abortifacient Agents; Abortifacient Agents, Nonsteroidal - administration & dosage; Abortifacient Agents, Nonsteroidal - adverse effects; Abortion; Abortion, Incomplete - drug therapy; Administration; Administration, Intravaginal; Adult; Analgesics - therapeutic use; Anti-Bacterial Agents - therapeutic use; Bacterial Infections - etiology; Bacterial Infections - prevention & control; Bacterial Infections/etiology/prevention & control; Biological and medical sciences; Clinical trials; Diseases of mother, fetus and pregnancy; Double-Blind Method; Drug therapy; effects; Female; First; Gynecology. Andrology. Obstetrics; Humans; Incomplete/drug therapy; Intravaginal; MEDICAL AND HEALTH SCIENCES; Medical sciences; MEDICIN OCH HÄLSOVETENSKAP; Miscarriage; Misoprostol - administration & dosage; Misoprostol - adverse effects; Misoprostol/administration & dosage/adverse effects; Nonsteroidal/administration & dosage/adverse; Pain - etiology; Pain - prevention & control; Pain/etiology/prevention & control; Pregnancy; Pregnancy Trimester; Pregnancy Trimester, First; Pregnancy. Fetus. Placenta; Treatment Outcome; Sweden; Pregnancy disorders; Gynecology; Abortion; Misoprostol; Obstetrics; Clinical management; Treatment; Placebo; Double blind study; Clinical trial; Early; Comparative study; Prostaglandin derivatives
• ISSN: 1470-0328; 1471-0528
• DOI: 10.1111/j.1471-0528.2005.00632.x

Objectives  To study if misoprostol 400 μg, administered vaginally, increased the successful resolution of early miscarriage compared with placebo. Design  Randomised, double blind placebo controlled study. Setting  Sahlgrenska University Hospital, Göteborg, Sweden. Sample  One hundred and twenty‐six women seeking medical attention for early miscarriage. Method  Women with a non‐viable, first trimester miscarriage were randomised to vaginal administration of misoprostol 400 μg or placebo. Main outcome measures  Main outcome measure was the proportion of successful complete resolution of miscarriage. Secondary outcomes were incidence of infection, bleeding, gastrointestinal side effects, pain, use of analgesics and length of sick leave between groups. Results  Sixty‐four patients were randomised to misoprostol and 62 to placebo. Eighty‐one percent in the misoprostol and 52% in the placebo group had a complete miscarriage within one week of the primary visit (RR 1.57; 95% CI 1.20–2.06). Patients in the misoprostol group reported more pain as assessed on a visual analogue scale (60.4 [31.0] vs 43.8 [37.1] mm; P < 0.007) and required analgesics more often (83%vs 61%, RR 1.35; 95% CI 1.08–1.70). There were no significant differences in the occurrence of gastrointestinal side effects, infection, reduction in haemoglobin or sick leave between the groups. Conclusions  Treatment with 400 μg misoprostol administered vaginally increased the success rate of resolvement of uncomplicated early miscarriages compared with placebo. However, women who received misoprostol experienced more pain and required more analgesics than those who did not.