Cefuroxime plus Azithromycin to reduce neonatal sepsis in preterm premature rupture of membranes between 24-33+6 weeks of gestation: a randomized controlled trial

Phase 2

• Conditions: Women with preterm premature rupture of membranes between 24-33+6 weeks of gestation requiring antibiotics for prolong latency period.; Preterm premature rupture of membranes; Preterm prelabor rupture of membranes; Antibiotics to prolong latency period; Early-onset neonatal sepsis; Randomized controlled trial

• Registration Number: TCTR20210724001
• Lead Sponsor: Ratchasapisek Sompoch grant

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-24
• Study Completion: 2022-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

1.Women with singleton pregnancy between 24 - 33+6 weeks of gestational age.
2.Women with first episode of premature rupture of membrane
3.No evidence of intra-amniotic infection (chorioamnionitis)*
4.Reassuring fetus evaluated by nonstress test (NST) or biophysical profile (BPP)*
* Subsequent discovery of an evidence of intraamniotic infection (chorioamnionitis) or non-reassuring fetus is not an exclusion.

Exclusion Criteria

1.Women with preterm labor with spontaneous rupture of membrane
2.Immunocompromised status such as human immunodeficiency virus infection, over diabetes mellitus etc.
3.Women with an autoimmune disease such as systemic lupus erythematosus,
rheumatoid arthritis and anti-phospholipid syndromes etc.
4. Women with known infection such as septicemia, pneumonia and pyelonephritis etc.
5.Women with already prescribed antibiotics within 7 days before the onset of preterm premature rupture of membrane.
6.History of Penicillin, Cephalosporin or Macrolide allergy.
7.Women with a contraindication for expectant management in case of preterm premature rupture of membrane such as intraamniotic infection, fetal non-reassuring.
8.Women with a fetal lethal anomaly *
9.History of obstetric operation or procedure in the current pregnancy such as cervical cerclage, fetal surgery) and Amniocentesis etc.
10.Women with abdominal trauma before the onset of preterm premature rupture of membrane.
11.Women with an active genital lesion such as genital herpes, herpes zoster, and Condyloma accuminata etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early onset neonatal sepsis 72 hours after birth Clinical assessment by pediatricians and neonatologists

Secondary Outcome Measures

Name	Time	Method
atency period at least 48 hours after onset of PPROM the onset of PPROM to the time of delivery,Chorioamnionitis (intraamniotic infection) Intrapartum period Triple I criteria,Postpartum maternal infection 6 weeks after delivery Clinical assessment by obstetricians,Intrapartum maternal fever Intrapartum period Triple I criteria,Neonatal respiratory distress 6 weeks after birth Clinical assessment by pediatricians and neonatologists,APGAR score at 5th minute 5 minutes after birth APGAR score