Home » Trials » SLCTR/2014/013
Use of prophylactic antibiotic (cefuroxime) for prelabour rupture of membranes (PROM) at term in early induction of labour
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SLCTR Registration Number
SLCTR/2014/013
Date of Registration
The date of last modification
Apr 30, 2019
Trial Status
Scientific Title of Trial
Use of prophylactic antibiotic (cefuroxime) for prelabour rupture of membranes (PROM) at term in early induction of labour
Public Title of Trial
Use of antibiotics to prevent infections in mothers with rupture of membranes before labour after 37 weeks of pregnancy
Disease or Health Condition(s) Studied
Prelabour rupture of membranes at term (PROM)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What is the effectiveness of prophylactic cefuroxime compared to standard therapy in mothers presented with prelabour rupture of membranes at term (>37 weeks of POG) in reducing feto-maternal & neonatal infections?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Available
Intervention(s) planned
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 from admission & the 1st dose will be given prior to the induction of labour continuing for 3 days..
The control group will not receive any prophylactic antibiotic (standard therapy).
Both groups will be induced in labour room with intravenous oxytocin, primi gravidae with 5 units & multi gravidae with 2 units, starting with a drop rate of 10 drops/min & the drop rate will be titrated according to the contractions with a maximum of 5 contractions/10 min as routinely practiced once initial evaluation being done at ante natal ward. (Early induction method)
Inclusion 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
Primary outcome(s)
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1.
Maternal & foetal
Post-partum sepsis is diagnosed by fever >38oC with positive blood culture.
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[ 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
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Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
124 (62 for each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2014-07-07
Anticipated end date
2014-11-30
Date of first enrollment
2014-10-07
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-12-19
Approval number
N/A
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Peradeniya |
| Institutional Address: | Galaha Road, Kandy, Sri Lanka |
| Telephone: | +94-812396361 |
| Email: | chairpersonierc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. S N M Punsiri Kamal Gunathilaka,
Registrar (Gynaecology & Obstetrics),
Professorial Unit- Gynaecology & Obstetrics, Teaching Hospital - Peradeniya.
Tel: 0812 388 261 (Extention 303,310,311)
Mob: 0772094335, 0717094335
Fax: None
punsirikamal@yahoo.com
Contact Person for Public Queries
Dr. Asoka Karunananda
Head - Department of Obstetrics & Gynaecology, Consultant Obstetrician & Gynecologist
Professorial Unit, Teaching Hospital, Peradeniya.
Tel: (094) 81 239 6450
Fax: (094) 81 238 9106
gynobspera@yahoo.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
