A randomized controlled trial on the effectiveness of prophylactic antibiotics compared to standard therapy on prevention of feto maternal and neonatal infections.

Antibiotic prophylaxis for prelabour rupture of membrane (PROM) at term in pregnant women presented to Obstetric Professorial Unit of Teaching Hospital Mahamodara- A Randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2019/033

Enrollment

Unknown

Registered

2019-09-26

Start date

2019-10-01

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 membrane(PROM)

Interventions

Consecutive patients admitted to Obstetrics Professorial Unit of Teaching Hospital Mahamodara with PROM after 37 weeks of gestational age from 01/10/2019 until required sample is achieved. Eligible p

Eligibility

Inclusion criteria

Inclusion criteria: 1.Women with PROM > 37 weeks and < 41 weeks of gestational age 2. Women with singleton fetus with cephalic presentation 3. Women with no uterine contraction on admission 4. Women with ruptured membrane less than 12 hours

Exclusion criteria

Exclusion criteria: 1.Contraindication for normal vaginal delivery 2.Planned EL/LSCS or indication for EM/ LSCS on admission 3.Death in utero or fetal anomaly 4.Contraindication for oxytocin or prostaglandins 5.Allergic to erythromycin 6. Presence of an indication to start Group B Streptococcal antibiotic prophylaxis

Design outcomes

Primary

Measure	Time frame
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. Fetal tachycardia > 160 bpm d. Uterine tenderness e. Offensive vaginal discharge f. CRP> 40 mg/ dL g. WBC count> 15109/L [ 72 hours after delivery. ] 2. Postpartum endometritis: diagnosed by pyrexia >38 C after 24 hours of delivery in the absence of other maternal cause with one of the following a. Uterine tenderness b. WBC count > 15109/L c. CRP> 20 mg/ dL [ 72 hours after delivery. ] 3.Postpartum Sepsis - Diagnosed if mother has pyrexia > 38 C with positive blood culture [ 72 hours after delivery. ] 4. Intrapartum fever [ 72 hours after delivery] 5. APGAR Score at 1st minute and 5th minute [ To be measured 8 hourly for 72 hours] 6. Special care baby unit admissions and duration [ To be measured 8 hourly for 72 hours] 7. Need for neonatal oxygen therapy & duration [ To be measured 8 hourly for 72 hours] 8. Need for neonatal ventilation and duration [ To be measured 8 hourly for 72 hours] 9. Need for neonatal intravenous antibiotics and duration [To be measured 8 hourly for 72 hours] 10.Neonatal sepsis [ To be measured 8 hourly for 72 hours]	—

Measure

Time frame

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. Fetal tachycardia > 160 bpm d. Uterine tenderness e. Offensive vaginal discharge f. CRP> 40 mg/ dL g. WBC count> 15*109/L [ 72 hours after delivery. ] 2. Postpartum endometritis: diagnosed by pyrexia >38 C after 24 hours of delivery in the absence of other maternal cause with one of the following a. Uterine tenderness b. WBC count > 15*109/L c. CRP> 20 mg/ dL [ 72 hours after delivery. ] 3.Postpartum Sepsis - Diagnosed if mother has pyrexia > 38 C with positive blood culture [ 72 hours after delivery. ] 4. Intrapartum fever [ 72 hours after delivery] 5. APGAR Score at 1st minute and 5th minute [ To be measured 8 hourly for 72 hours] 6. Special care baby unit admissions and duration [ To be measured 8 hourly for 72 hours] 7. Need for neonatal oxygen therapy & duration [ To be measured 8 hourly for 72 hours] 8. Need for neonatal ventilation and duration [ To be measured 8 hourly for 72 hours] 9. Need for neonatal intravenous antibiotics and duration [To be measured 8 hourly for 72 hours] 10.Neonatal sepsis [ To be measured 8 hourly for 72 hours]

—

Countries

Sri Lanka

Contacts

Public ContactDr. T. D. Ruchira Lasanga

Registrar ( Gynaecology & Obstetrics)

r.lasanga@gmail.com0912267052

Outcome results

None listed

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