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Use of antibiotics to prevent infections in mothers with rupture of membranes before labour after 37 weeks of pregnancy

Use of prophylactic antibiotic (cefuroxime) for prelabour rupture of membranes (PROM) at term in early induction of labour

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2014/013
Enrollment
Unknown
Registered
2014-07-07
Start date
2014-07-07
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Prelabour rupture of membranes at term (PROM)

Interventions

Consenting participants will be randomized into two groups. The intervention group will receive intravenous cefuroxime 750mg 8 hrly for 24 hrs followed by oral cefuroxime 500 mg 12 hourly for 48 hrs

Sponsors

Professorial Unit (Gynaecology & Obstetrics)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant mothers with confirmed gestational age more than 37 & less than 42 weeks. 2. Singleton pregnancies with cephalic presentation 3. Ruptured membranes for less than 12hrs 4. Absence of uterine contractions on admission

Exclusion criteria

Exclusion criteria: Mothers with following complications, on admission will be excluded from the study 1. Foetal death or anomaly 2. Placenta praevia 3. Placental abruption 4. Chorioamnionitis 5. Indicated for a caesarean section on admission 6. Allergic to Cefuroxime, other cephalosporins or to penicillins 7. Contraindicated for the use of oxytocin

Design outcomes

Primary

MeasureTime frame
Maternal & foetal 1.Chorioamnionitis: Diagnosed according to the Southern Australian Perinatal Practice Guidelines a. Maternal pyrexia (>38c) & at least two of following b. Maternal tachycardia > 100 bpm c. Foetal tachycardia >160 bpm d. Uterine tenderness e. Offensive vaginal discharge f. CRP >40 mg/L g. Increased WBC count (>15 x 109/L ) 2. Postpartum endometritis Diagnosed by pyrexia >38oC, after 24 hours of delivery in the absence of other maternal causes, with one of the following a. Uterine tenderness b. WBC count >15 x 109/L, c. CRP >20 mg/L. Post-partum sepsis is diagnosed by fever >38oC with positive blood culture. 3. Neonatal out comes Neonatal sepsis:Diagnosed by raised CRP (>20 mg/L), WBC 30 x 109/L or positive blood cultures with minimum of one of the following clinical signs: hyperthermia/ hypothermia, lethargy, poor feeding, tachypnea, vomiting or abdominal bloating. [1a. Maternal pyrexia: 8 hourly for 72 hours after delivery 1b. Maternal pulse and other factors measured if there is pyrexia 1c. Foetal heart rate: every 15 minutes using hand held doppler, until delivery 2a. Maternal pyrexia and uterine tenderness assessed every 8 hours for 72 hours. 2b. Other investigations to be done if maternal temperature >38oC 3. Neonatal outcomes be measured 8 hourly for 72 hours]

Secondary

MeasureTime frame
None [None]

Countries

Sri Lanka

Contacts

Public ContactDr. S N M Punsiri Kamal Gunathilaka,

Registrar (Gynaecology & Obstetrics),

punsirikamal@yahoo.comTel: 0812 388 261 (Extention 303,310,311)

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026