Home » Trials » SLCTR/2019/033
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
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SLCTR Registration Number
SLCTR/2019/033
Date of Registration
The date of last modification
Sep 15, 2020
Scientific Title of Trial
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
Public Title of Trial
A randomized controlled trial on the effectiveness of prophylactic antibiotics compared to standard therapy on prevention of feto maternal and neonatal infections.
Disease or Health Condition(s) Studied
Prelabour rupture of membrane(PROM)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1240-1120
Any other number(s) assigned to the trial and issuing authority
2019/P/031
What is the research question being addressed?
Is prophylactic antibiotic therapy effective in reducing feto- maternal & neonatal infections compared to standard therapy in mothers who present with prelabour rupture of membrane at term (> 37 weeks of period of gestation)?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded : Participants
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Phase 3
Intervention(s) planned
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 patients will recruited to the study after getting informed written consent. On admission random number (between 1- 160 ) will be selected by patients. If number is even , they will be allocated into intervention group. If number is odd, they will be allocated into control groups.
The intervention group will receive oral erythromycin 250 mg 6 hourly for 3 days since admission. The control group will not receive any prophylactic antibiotic. All women in both groups will be managed according to current practice protocol.
If spontaneous labour occurs within 12 hours, patients will be sent to labour room and routine care provided. If labour does not occur spontaneously after 12 hours, a sterile speculum examination & Modified Bishop Score (MBS) assessment will be done. If the cervix is unfavorable (MBS < 4), 3 mg prostaglandin will be inserted into the vagina after performing a cardiotocography, 6 hours prior to starting an oxytocin infusion. Digital vaginal examination will be avoided until the onset of active labour. In the labour room, induction of labour will be carried out according to the National Guideline for the use of oxytocin for induction & augmentation of labour.
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
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
Primary outcome(s)
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1.
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. ] |
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2.
|
[ 72 hours after delivery. ] |
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3.
3.Postpartum Sepsis - Diagnosed if mother has pyrexia > 38 C with positive blood culture |
[ 72 hours after delivery. ] |
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4.
|
[ 72 hours after delivery ] |
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5.
|
[ To be measured 8 hourly for 72 hours ] |
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6.
|
[ To be measured 8 hourly for 72 hours ] |
|
7.
|
[ To be measured 8 hourly for 72 hours ] |
|
8.
|
[ To be measured 8 hourly for 72 hours ] |
|
9.
|
[ To be measured 8 hourly for 72 hours ] |
|
10.
10.Neonatal sepsis |
[ To be measured 8 hourly for 72 hours ] |
Secondary outcome(s)
Target number/sample size
160 ( 80 for each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2019-10-01
Anticipated end date
2020-09-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
self funded
Regulatory approvals
NMRA
Status
Approved
Date of Approval
2019-06-18
Approval number
2019/P/031
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | P.O Box:70, Galle, Sri Lanka |
| Telephone: | 091-2234801/803 |
| Email: | www.medi.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Dr. T. D. Ruchira Lasanga
Registrar ( Gynaecology & Obstetrics)
Professorial Unit- Gynaecology & Obstetrics,
Teaching Hospital,
Mahamodara.
0912267052
0714599196
None
r.lasanga@gmail.com
Contact Person for Public Queries
Dr(Mrs) A. G.I. Mampitiya
Senior Lecturer in Obstetrician & Gynaecologist
Professorial unit
Teaching Hospital,
Mahamodara.
0777921588
dr.ireshag@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
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
