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Adjunctive Azithromycin Prophylaxis for Preventing Cesarean Scar Defect

The infectious etiology of the cesarean scar defect and the prevention effect of the application of azithromycin in caesarean section

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013272
Enrollment
Unknown
Registered
2017-11-07
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cesarean scar defect (CSD)

Interventions

Control:Single dose of cefuroxime (2.0g /50ml NaCl0.9 %) and placebo 50ml NaCl0.9 % ivggt
Experimental group:Single dose cefuroxime (2.0g /50ml NaCl0.9 %) with a single dose of azithromycin (0.5 g/50ml NaCl0.9 %)

Sponsors

The International Peace Maternity & Child Health Hospital affiliated to Shanghai JiaoTong university
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Han nationality, Aged between 20 to 40 years old, gestational age= 37 weeks, or preoperative fibrinogen acuity =2.0 g/L, preoperative platelet= 100*10^9/L or higher, preoperative hemoglobin = 90 g/L.

Exclusion criteria

Exclusion criteria: 1. disagree of informed consent; 2. known allergies to the azithromycin (including other macrolides antibiotic) or cefuroxime (including other second generation cephalosporins); 3. the patients finally reached vaginal delivery; 4. no used of azithromycin, within 7 days before randomization; 5. vaginal group B hemolytic streptococcus (GBS) positive; 6. chorioamnionitis or other postoperative supplementary use of antibiotics; 7. stillbirth; 8. severe liver and kidney dysfunction (liver cirrhosis or liver enzyme increased three times or more than normal ceiling or serum creatinine greater than or equal to 2.0 mg or 177 umol/L); 9. diarrhea when planning into the randomization; 10. myocarditis; 11. pulmonary edema; 12. maternal structural heart disease, or need to use the antiarrhythmic drugs for the heart disorders; 13. diagnosis of uterine anomalies before, such as abnormal uterus (uterus unicornis, mediastinum uterus, double uterus, uterus bicornis) and uterine fibroids or adenomyosis; 14. those who have rheumatoid arthritis or other special conditions with joint pain.

Design outcomes

Primary

MeasureTime frame
cesarean scar defect;

Secondary

MeasureTime frame
CBC;CRP;PCT;coagulation function;

Countries

China

Contacts

Public ContactDing Huang

The International Peace Maternity & Child Health Hospital affiliated to Shanghai JiaoTong university

dingding123hos@163.com+86 13817771640

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026