| CTRI Number |
CTRI/2024/10/075599 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Maternal and Fetal outcomes in preterm premature rupture of membranes |
|
Scientific Title of Study
|
Maternal and Fetal outcomes in preterm premature rupture of membranes- An
Observational study At KLES Dr Prabhakar Kore Hospital and Medical College
and Research Centre Belagavi
|
| 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 Nidhi Singh Badhoriya |
| Designation |
Junior Resident |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department Of Obstetrics and Gynaecology J.N. Medical College
Belagavi
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7828824521 |
| Fax |
|
| Email |
nidhi.jiya21.ns@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yeshita V Pujar |
| Designation |
Head of the department |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Obstetrics and Gynaecology J.N. Medical College
Belagavi
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9448142989 |
| Fax |
|
| Email |
yvpujar@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Singh Badhoriya |
| Designation |
Junior Resident |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Department of Obstetrics and Gynaecology J.N. Medical College
Belagavi
Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7828824521 |
| Fax |
|
| Email |
nidhi.jiya21.ns@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLEH,Dr Prabhakar kore hospital,JNMC,Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr.Nidhi Singh Badhoriya |
| Address |
Department of Obstetrics and Gynaecology J.N. Medical College,
Belagavi -590010
Karnataka
|
| 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 Nidhi Singh badhoriya |
Jawaharlal Nehru Medical College, KLEH, Belagavi |
G-1 ,Sagar ward,labour room ,KLE Dr Prabhakar kore hospital
Belgaum
KARNATAKA |
07828824521
Nidhi.jiya21.ns@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O429||Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, (3) ICD-10 Condition: O429||Premature rupture of membranes, unspecified as to length of time between rupture and onset of labor, (4) 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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Pregnant women admitted with pPROM at more than or equal to 28 weeks to 33 weeks 6days period of gestation
2.Diagnosis of pPROM by -
Active pv leak on per speculum examination
History of pv leak and on per speculum examination no leak present with usg suggestive of anamnios,severe oligohydramnios
|
|
| ExclusionCriteria |
| Details |
Intra uterine death |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the maternal and fetal outcomes in cases of preterm premature rupture of membranes between gestational age of 28 weeks to 33 weeks 6 days |
33 weeks 6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the causes of preterm premature rupture of membranes |
33 weeks 6 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
N/A |
|
Date of First Enrollment (India)
|
27/10/2024 |
| 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 - NO
|
|
Brief Summary
|
Premature Rupture Of Membrane(PROM) is defined as the spontaneous rupture of fetal membranes prior to the onset of labor. Membrane rupture before labor that occurs before 37 weeks of gestation is referred to as preterm pre-labor rupture of membranes. PROM is one of the most challenging obstetric dilemma which occurs even in low risk pregnancies and can convert a traditional pregnancy into high risk nregnancy. Incidence of PROM at term is approximately 8% and pPROM is 3% of all pregnancies.pPROM (28weeks-33weeks 6 days) incidence is 1.45% In developing countries, the incidence of PROM is about 18-20% PROM is associated with 20% of neonatal deaths. Management of PROM remains a matter of great debate till date. Accurate prediction of maternal chorioamnionitis and early onset neonatal infections remains a critical challenge and is associated with increased neonatal morbidity and mortality. Neonatal complications include early onset neonatal infections ,birth asphyxia, hyperbilirubinaemia , late onset sepsis , congenital pneumonia , bronchia-pulmonary dysplasia. Incidence and prevalence of the above complications are not known in KLEs S Dr Prabhakar Kore charitable Hospital and Medical Research Centre Belagavi. Hence the study is being carried out to study the above mentioned complications and their incidence and prevalance |