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CTRI Number  CTRI/2024/08/072969 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   7 days versus until delivery for prophylactic antibiotic treatment in preterm premature rupture of membranes. 
Scientific Title of Study   Prophylactic antibiotic treatment duration in preterm premature rupture of membranes: 7 days versus until delivery 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Guddad Shabana Hameed 
Designation  Junior Resident [Post Graduate] 
Affiliation  SHRI BM PATIL MEDICAL COLLEGE AND HOSPITAL 
Address  OBG OPD NO 2 Shri B M Patil Medical College and Hospital BLDE Bangaramma Sajjan Campus Solapur Road Vijayapur 586103

Bijapur
KARNATAKA
586103
India 
Phone  9449741495  
Fax    
Email  shabanaguddad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shobha Shiragur 
Designation  Professor 
Affiliation  SHRI BM PATIL MEDICAL COLLEGE AND HOSPITAL 
Address  OBG OPD NO 2 Shri B M Patil Medical College and Hospital BLDE Bangaramma Sajjan Campus Solapur Road Vijayapur 586103

Bijapur
KARNATAKA
586103
India 
Phone  9663330846  
Fax    
Email  shobha.shiragur@bldedu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Guddad ShabanaHameed 
Designation  Junior Resident [Post Graduate] 
Affiliation  SHRI BM PATIL MEDICAL COLLEGE AND HOSPITAL 
Address  OBG OPD NO 2 Shri B M Patil Medical College and Hospital BLDE Bangaramma Sajjan Campus Solapur Road Vijayapur

Bijapur
KARNATAKA
586103
India 
Phone  9449741495  
Fax    
Email  shabanaguddad@gmail.com  
 
Source of Monetary or Material Support  
SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL RESEARCH CENTER SMT BANGARAMMA SAJJAN CAMPUS SOLAPUR ROAD VIJAYAPUR 586103  
 
Primary Sponsor  
Name  SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL 
Address  OBG OPD NO 2 Shri Patil Medical College and Hospital BLDE Bangaramma Sajjan Campus Solapur Road, District Bijapur 586103 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Guddad Shabana Hameed  SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE VIJAYPURA   OBG OPD NO 2DEPRATEMENT OF OBG VIJAYAPUR
Bijapur
KARNATAKA 		 9449741495

shabanaguddad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, VIJAYPURA INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O421||Premature rupture of membranes, onset of labor more than 24 hours following rupture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  inj ceftriaxone, inj metronidazole, tab clarithromycin   inj ceftriaxone 1 gm iv bd x2days , inj metronidazole 100ml iv tid x 2days tab claritromycin 500mg bd x 5days 
Intervention  inj ceftriaxone, inj metronidazole, tab clarithromycin   inj ceftriaxone 1gm iv bd x 2days , inj metronidazole 100ml iv tid x 2days tab clarithromycin 500mg bd until delivery until delivery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1)Gestational age of 26weeks+0 days to 36weeks+6days
2)PPROM within 72 hours with cervical dilatation less than 3cms
3)Singleton pregnancy
4)Foetal anomalies
5)Abnormal placentation
6)Maternal comorbidities
7)Recentaly documented infections of urogenital tract  
 
ExclusionCriteria 
Details  1)fetal anomaly
2)abnormal placentation
3)maternal comorbiditis
4)h/o cervical incompitance
5)recent infections of urogenital tract 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The duration of antibiotic theraphy Ceftrioxone and Clarithromycin until delivery in pprom shows reduced incidence of neonatal morbidity.
 		 7 days to until delivery
 
 
Secondary Outcome  
Outcome  TimePoints 
The duration of antibiotic theraphy ceftrioxone & clarithromycin untill delivery in pprom shows reduced incidence of infantile neurological outcomes
 		 7 days to until delivery
 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   04/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   ï‚· One of the most common causes of preterm birth is Preterm Premature Rupture of membranes (PPROM). ï‚· The ideal approach to the clinical assessment and treatment of women with and preterm PROM remains debatable. ï‚· Management depends on gestational age and evaluation of the relative risks of delivery versus the risks of expectant management. ï‚· PPROM constitutes 2-3% of all complicated pregnancies and is one of the major causes of preterm deliveries and is associated with neonatal morbidity. ï‚· The key strategy to prolong the interval from rupture of membranes to the delivery in PPROM patients is antibiotic therapy. The treatment was proved to be effective in both prolongation of pregnancy and improvement of short-term neonatal outcomes.  
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