| CTRI Number |
CTRI/2024/04/065733 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of two different antibiotics courses in prevention of unfavourable health results of mother and baby in case of early rupture of membranes |
|
Scientific Title of Study
|
Comparison of efficacy of two prophylactic antibiotic regimens for PPROM-A randomised controlled trial |
| 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 Jyoti |
| Designation |
Junior Resident |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY, LUCKNOW |
| Address |
Department of Obstetrics and Gynaecology Queen Mary Hospital King George Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8077810729 |
| Fax |
|
| Email |
jyotisingh15898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjulata Verma |
| Designation |
Assistant Professor |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY, LUCKNOW |
| Address |
Department of Obstetrics and Gynaecology Queen Mary Hospital King George medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9721250092 |
| Fax |
|
| Email |
gaganmlv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti |
| Designation |
Junior Resident |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY, LUCKNOW |
| Address |
Department of Obstetrics and Gynaecology Queen Mary Hospital King George Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8077810729 |
| Fax |
|
| Email |
jyotisingh15898@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of obstetrics and gynaecology queen mary hospital king georges medical university |
|
|
Primary Sponsor
|
| Name |
DrJyoti |
| Address |
Junior resident ,Department of obstetrics and gynaecology queen mary hospital king georges medical university |
| Type of Sponsor |
Other [Self] |
|
|
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 jyoti |
Queen Mary Hospital, King George Medical University |
Room no.1 Labour Room Complex,Department of Obstetrics and Gynaecology,Queen Mary Hospital,King Georges Medical University
Lucknow
UTTAR PRADESH |
8077810729
jyotisingh15898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George medical University institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O429||Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AMPICILLIN AND AZITHROMYCIN |
Patients giving informed written consent with singleton pregnancy with diagnosis of PPROM after 24 weeks and before 37 WEEKS will be randomized into 2 groups, viz. group A and group B 2. Under single blinding to remove observation bias, randomization will be done using sequentially numbered opaque container technique where both types of antibiotics are stored in opaque containers and dispensed to the patients or using random draw of lot 3. Patients will be admitted and following investigations will be done a. HB, TLC b. CRP c. Urine routine and microscopy and cultures d.high vaginal cultures 4. Prophylactic antibiotics as described below will be started for prolonging the latency and to reduce the maternal and neonatal complications a. Group A - ampicillin and azithromycin Inj.ampicillin 2mg QID for 48 hours+Tab azithromycin 1gm PO STAT.followed by Tab Amoxycillin 250mg TDS +Tab Erythromycin 250mg TDS for 5days |
| Intervention |
Cefuroxime and azithromycin |
Patients giving informed written consent with singleton pregnancy with diagnosis of PPROM after 24 weeks and before 37 WEEKS will be randomized into 2 groups, viz. group A and group B 2. Under single blinding to remove observation bias, randomization will be done using sequentially numbered opaque container technique where both types of antibiotics are stored in opaque containers and dispensed to the patients or using random draw of lot 3. Patients will be admitted and following investigations will be done a. HB, TLC b. CRP c. Urine routine and microscopy and cultures d.high vaginal cultures 4. Prophylactic antibiotics as described below will be started for prolonging the latency and to reduce the maternal and neonatal complications.
Group B-cefuroxime and azithromycin
Inj.cefuroxime 750 mg TDS for 48 hours+Tab azithromycin 1gm PO STAT.followed by Tab Amoxycillin 250mg TDS +Tab Erythromycin 250mg TDS for 5days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
– Patient giving written informed consent
– Singleton pregnancy, PPROM after 24 weeks of gestation & before 37 weeks. |
|
| ExclusionCriteria |
| Details |
-Not giving consent
– Conditions requiring expedite delivery or contraindication of conservative management like: Chorioamnionitis
Fetal distress
Placental abruption
Active labour |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Latency period
Early neonatal sepsis rate-positive blood culture
Chorioamnionitis rate
|
Latency period-date of randomisation until date of delivery
Early neonatal sepsis rate- within 3 days of delivery
Chorioamnionitis rate-from day of randomisation until date of clinical/laboratory Chorioamnionitis diagnosis assessed up to 10 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neonatal weight
Apgar score
Neonatal intensive care unit (NICU) admission duration |
Neonatal weight [ Time Frame: at delivery] grams
Apgar score [ Time Frame: 1 minute - 5minutes] score from 0 to 10 Other Neonatal intensive care unit (NICU) admission duration [Time Frame: days since delivery until rerelease from NICU, assessed up to 6 months] |
|
|
Target Sample Size
|
Total Sample Size="232"
Sample Size from India="232"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jyotisingh15898@gmail.com].
- For how long will this data be available start date provided 09-02-2025 and end date provided 09-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Assessed for Eligibility (n) ,excluded(x)-Chorioamnionitis ï‚· Fetal distress ï‚· Placental abruption ï‚· Active labour ï‚· Not giving consent All cases of PPROM meeting inclusion criteria Randomized (n-x=232) Group A = 116 AMPICILLIN AND AZITHROMYCIN : INJ.AMPICILLIN 2GM QID I.V FOR 48 HOURS+ TAB. AZITHROMYCIN 1GM STAT. FOLLOWED BY TAB AMOXICILLIN 250 MG TDS + TAB ERYTHROMYCIN 250MG TDS FOR 5 DAYS.
Group B=116 CEFUROXIME AND AZITHROMYCIN : INJ.CEFUROXIME 750 MG TDS FOR 48 HOURS + TAB AZITHROMYCIN 1GM PO STAT. FOLLOWED BY TAB AMOXICILLIN 250 MG TDS + TAB ERYTHROMYCIN 250MG TDS FOR 5 DAYS.
Fetal Monitoring  DFMC, NST, Biophysical profile twice a week  Maternal Monitoring  For signs of infection – PR, Temp, uterine discharge, TLC, CRP  Screening for infection  Urine & Vaginal culture
ï‚· Comparison of: ï‚· Latency period ï‚· Adverse neonatal outcome ï‚· Maternal infectious morbidity |