| CTRI Number |
CTRI/2018/03/012449 [Registered on: 09/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a clinical trial to study the efficacy of combination of two drugs,ampicillin plus azithromycin and ampicillin plus erythromycin in pregnant patients with preterm premature rupture of membranes |
|
Scientific Title of Study
|
a prospective study to compare the efficacy of combination of ampicillin and azithromycin with ampicillin and erythromycin for prolonging latency in preterm premature rupture of membranes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRPAPIA SAHA |
| Designation |
DEMONSTRATOR, COMMUNITY MEDICINE |
| Affiliation |
COLLEGE OF MEDICINE AND SAGORE DUTTA HOSPITAL |
| Address |
578 BARRACKPORE TRUNK ROAD, KOLKATA-58
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
91-9433207704 |
| Fax |
|
| Email |
papia.saha@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRPAPIA SAHA |
| Designation |
DEMONSTRATOR, COMMUNITY MEDICINE |
| Affiliation |
COLLEGE OF MEDICINE AND SAGORE DUTTA HOSPITAL |
| Address |
578 BARRACKPORE TRUNK ROAD, KOLKATA-58
North Twentyfour Parganas
WEST BENGAL
700028
India |
| Phone |
91-9433207704 |
| Fax |
|
| Email |
papia.saha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR TULIKA JHA |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OFG&O |
| Affiliation |
R.G.KAR MEDICAL COLLEGE |
| Address |
1 KHUDIRAM BOSE SARANI, KOLKATA-04
Kolkata
WEST BENGAL
700004
India |
| Phone |
91-9830294901 |
| Fax |
|
| Email |
drtulikajha@gmail.com |
|
|
Source of Monetary or Material Support
|
| R G KAR MEDICAL COLLEGE KOLKATA
1 KHUDIRAM BOSE SARANI, KOLKATA-04, DISTRICT-KOLKATA,WEST BENGAL, PIN- 700004, INDIA |
|
|
Primary Sponsor
|
| Name |
RGKAR MEDICAL COLLEGE KOLKATA |
| Address |
1 KHUDIRAM BOSE SARANI, KOLKATA-04, DISTRICT - KOLKATA, PIN-700004, WEST BENGAL, INDIA |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PAPIA SAHA |
R G KAR MEDICAL COLLEGE DEPARTMENT OF G&O |
1 KHUDIRAM BOSE SARANI,KOLKATA-04
Kolkata
WEST BENGAL |
919433207704
papia.saha@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE, R.G.KAR MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
pregnant with preterm premature rupture of membranes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ampicillin plus Azithrymycin |
Injection ampicillin 02 gm IV six hourly for 48 hrs, Azithromycin from third day 500 mg orally once daily for five days. |
| Comparator Agent |
Ampicillin plus Erythromycin |
Injection ampicillin 02 gm IV six hourly for 48 hrs,Erythromycin from third day,500mg orally 6 hrly for 5 days. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of 19 years to 40 years of age with preterm premature rupture of membranes and not in labour.
Gestational age of 28 to 34 weeks.
Single foetus gestation
Randomization within 36 hours of rupture of membranes.
Cervical dilatation less than or equal 04 cm. |
|
| ExclusionCriteria |
| Details |
Gestational age <24 weeks and >34 weeks
In preterm labour
Cervical cerclage in situ
Multifetal gestation
Vaginal bleeding/Foul smelling vaginal discharge
Maternal or foetal indication for delivery
Placental abnormality
H/o amniocentesis
Had received corticosteroid or antibiotic within the last seven days
Carrying a foetus with lethal anomalies
H/o foetal surgery
H/o abdominal trauma
On antiretroviral therapy
Known allergy or cntraindication to use of ampicillin, azithromycin and erythromycin.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Latency |
Latency - from first antibiotic dose administration to the time of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety of antibiotics
Gestational age at delivery
Chorioamnionitis
Puerperal sepsis
Birth weight
APGAR score at birth
RDS
Neonatal sepsis
Neonatal mortality
Number of days of stay in NICU
|
Puerperal sepsis-within 42 days of delivery
Neonate-28 days of age |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/07/2015 |
| Date of Study Completion (India) |
30/06/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was a randomized prospective controlled study comparing the efficacy of combination of two drugs ampicillin plus azithromycin(group-A) with ampicillin plus erythromycin(Group-B) in pregnant patients with preterm premature rupture of membranes. The study was conducted at R.G.KAR Medical college, Kolkata with a samle size 114 and study duration of one year. The primary outcome of the study was latency and the secondary outcomes were safety of antibiotics,gestational age at delivery,chorioamnionitis,puerperal sepsis,birth weight,APGAR score,RDS(respiratory distress syndrome),neonatal sepsis, neonatal mortality,days of NICU stay. After statistical analysis, no statistical difference was found between two groups in term of latency,maternal and neonatal outcomes except statistically significant difference in mean birth weight and NICU stay between two groups.
|