Pervention and Intervention of infections following Caesarean Sectio

Phase 1

• Conditions: Sub-study 1: women delivering a child by caesarean section Sub-study 2: Women, who are hospitalized at the obstetrical ward for reoperation because of superficial or deep infection or haematoma after caesarean section; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2012-002068-29-DK
• Lead Sponsor: Jan Stener Joergensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-13
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 2844

Inclusion Criteria

Sub-study 1:
- Age = 18 year
- Women, who can read and understand Danish
- A gestational age = completed 28 weeks of gestation
- Rupture of membranes and active labour (uterine contractions) is allowed

Sub-study 2:
- Age = 18 year
- Women, who can read and understand Danish

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2844
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Sub-study 1:
- Hypersensitivity to cefuroxim or to any other cephalosporin antibiotics
- Previous immediate and/or severe hypersensitivity reaction to penicillin or any other beta-lactam antibiotic.
- Systemic exposure to any antibiotic agent within 1 week before delivery Antibiotic indicated due to PROM, fever, GBS or other indications at the time of caesarean section.
- Women being immunologically incompetent (e.g. HIV positive)

Sub-study 2:
- Serious illness requiring medical treatment, such as cancer
- Stillborn child
- If the fascia is ruptured

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified