FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093660 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 25/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A Study to Evaluate Foeto-Maternal Outcomes in Pregnant Women with Premature Rupture of Membranes and Preterm Premature Rupture of Membranes at a Single Hospital 
Scientific Title of Study   Prospective, Observational, Single center study to evaluate the foeto-maternal outcomes in Premature Rupture of Membranes and Preterm Premature Rupture of Membranes. 
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 Vaishali Choudhri 
Designation  Consultant Obstetrics and gynaecology 
Affiliation  Bhaktivedanta hospital and Research institute  
Address  OPD No. 3, D Wing, Department of Anesthesia, Ground Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  9321996831  
Fax    
Email  drvaishali231980@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Vaishali Choudhri 
Designation  Consultant Obstetrics and gynaecology 
Affiliation  Bhaktivedanta hospital and Research institute  
Address  OPD No. 3, D Wing, Department of Anesthesia, Ground Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  9321996831  
Fax    
Email  drvaishali231980@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR Vaishali Choudhri 
Designation  Consultant Obstetrics and gynaecology 
Affiliation  Bhaktivedanta hospital and Research institute  
Address  OPD No. 3, D Wing, Department of Anesthesia, Ground Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107.

Thane
MAHARASHTRA
401107
India 
Phone  9321996831  
Fax    
Email  drvaishali231980@gmail.com  
 
Source of Monetary or Material Support  
Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107. 
 
Primary Sponsor  
Name  Bhaktivedanta Hospital and Research Institute 
Address  Srishti complex ,bhaktivedanta swami marg, mira Road(East),Thane-41107 
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 
Dr Afsana Mansuri  Bhaktivedanta Hospital and Research Institute  OPD No. 3, D Wing, Department of Obstetrics and gynaecology,Ground Floor, Bhaktivedanta Swami Marg, Sector 6, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107
Thane
MAHARASHTRA 		 8291116464

afimansuri27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bhaktivedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Pregnant women with confirmed PROM (spontaneous rupture of membranes before the onset of labor).
2. Singleton pregnancies.
3. Gestational age more then or equal to 28 weeks.
4. Women willing to participate and provide informed consent.
 
 
ExclusionCriteria 
Details  1. Gestational age less than 28 weeks
2. Post caesarean pregnancy
3. Multiple pregnancies
4. Malpresentation
5. Ante partum haemorrhage
6. Meconium stained liquor
7. Congenital anomalies
8. Pregnant women with pre-existing maternal infections (e.g., HIV, active tuberculosis).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Maternal and neonatal outcomes will be monitored from admission until discharge, including maternal complications such as chorioamnionitis, postpartum hemorrhage, maternal sepsis, and cesarean delivery, as well as neonatal outcomes like sepsis, NICU admissions, low Apgar scores, preterm birth, respiratory distress syndrome, and perinatal mortality.  1 hour after the admission, 1 hour before discharge 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration from PROM to delivery & its impact on maternal & neonatal outcomes.
2. Mode of delivery (vaginal vs. cesarean section) & associated maternal morbidity.
3. Need for antenatal corticosteroids & its effect on neonatal respiratory outcomes in preterm PROM.
4. Prophylactic antibiotics (cefotaxime 1 gm BD & metronidazole 500 gms BD) use & its effectiveness in preventing maternal & neonatal infections.
5. Comparison of maternal & neonatal outcomes between term PROM (equal to or more then 37 weeks) & preterm PROM (less than 37 weeks).
 		 1 hour after the admission, 1 hour before discharge 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   08/09/2025 
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  

This is a prospective, observational, single-center study conducted at Bhaktivedanta Hospital and Research Centre, Thane, Maharashtra, aimed at evaluating maternal and neonatal outcomes in pregnancies complicated by Premature Rupture of Membranes (PROM) and Preterm PROM (PPROM). The study will include 86 pregnant women with singleton pregnancies and gestational age more than or equal to 28 weeks who present with spontaneous rupture of membranes before the onset of labor. Participants will be monitored from admission through delivery and postpartum, with data collected on maternal complications (e.g., chorioamnionitis, postpartum hemorrhage, sepsis), neonatal outcomes (e.g., birth weight, Apgar scores, NICU admission, neonatal sepsis), and interventions such as prophylactic antibiotics and corticosteroids. The study will also compare outcomes between term PROM (more than or equal to37 weeks) and preterm PROM (Less then 37 weeks). The findings aim to inform better clinical management and reduce maternal and neonatal morbidity associated with PROM.

 
Close