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CTRI Number  CTRI/2021/02/031241 [Registered on: 12/02/2021] Trial Registered Prospectively
Last Modified On: 11/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate between early and late induction of labor in term Prelabor rupture of membranes 
Scientific Title of Study   Study Of Immediate Induction Of Labor With Cerviprime gel and Delayed Induction Of Labor With Oxytocin at Term Prelabor 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  Dr Usha Nag 
Designation  Professor 
Affiliation  Dr.Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation 
Address  Dr. Usha Nag, MD OBG, Professor, Dept Of OBGY, DR.Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation, Chinnoutpalli, Gannavaram.

Krishna
ANDHRA PRADESH
521286
India 
Phone  9346259045  
Fax    
Email  drushanag@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parkuru Monica 
Designation  PG student 
Affiliation  Dr.Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation 
Address  Dept Of OBGY Dr.Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation, Chinnoutpalli, Gannavaram.

Krishna
ANDHRA PRADESH
521286
India 
Phone  9493273990  
Fax    
Email  pmonica@drpinnamanenisimsrf.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Parkuru Monica 
Designation  PG student 
Affiliation  Dr.Pinnamaneni Siddhartha Institute Of Medical Sciences And Research Foundation 
Address  DR.Pinnamaneni Siddhartha Institute Of Medical Sciences and Research Foundation, Chinnoutpalli, Gannavaram,

Krishna
ANDHRA PRADESH
521286
India 
Phone  9493273990  
Fax    
Email  pmonica@drpinnamanenisimsrf.edu.in  
 
Source of Monetary or Material Support  
DR.Pinnamaneni Siddhartha Institute Of Medical Sciences and research Foundation 
 
Primary Sponsor  
Name  Parkuru monica 
Address  DR.Pinnamaneni Siddhartha Institute Of Medical Sciences and research Foundation, Chinnoutpalli Gannavaram 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 Usha Nag  Dr. pinnamaneni Siddhartha Institute Of Medical Sciences and research Foundation  Dept of obgy
Krishna
ANDHRA PRADESH 
9346259045

drushanag@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC of Dr PSIMS and RF  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O420||Premature rupture of membranes, onset of labor within 24 hours of rupture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  12 hours observation for spontaneous labor if fails then induction or augmentation with oxytocin  the patients included are those with prelabor rupture of membranes with duration morethan or equal to 6 hours. They will be observed for 12hours for spontaneous onset of labor, if patient fails then induction or augmentation with intravenous oxytocin drip is started, 5U in 500ml ringer lactate solution in primigravida and 2.5U in 500ml ringer lactate solution in multiparous women with infusion rate of 4 drops per min. The rate of infusion is doubled every 20mins until the occurrence of 4 contractions lasting for 45 seconds in 10mins, upto maximum infusion rate of 32mIU/min. 
Intervention  In prom immediate induction with CERVIPRIME gel  they will be induced immediately within 6hours of prelabor rupture of membranes with intravaginal instillation of 0.5mg Prostaglandin E2 gel into posterior fornix. If bishop’s score doesnot improve after 6hours then application of Prostaglandin E2 gel is repeated maximum of two doses. After two doses of Prostaglandin E2 gel, labor augmentation will be done with oxytocin. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Singleton fetus with cephalic presentation.
Gestational age between 37-40 weeks.
Spontaneous rupture of membranes confirmed by history and examination.
Primi or multigravida.
Absent or mild uterine contractions (1-2 contractions lasting for 10-15 seconds).
Viable fetus.
Modified Bishop’s score <6.
Should present to labor room within 12hours of prelabor rupture of membranes. 
 
ExclusionCriteria 
Details  Multiple gestation.
Fetal Malpresentation.
Cephalopelvic disproportion.
Previous cesarean section or major uterine surgery.
Medical and Obstetric complications (Preeclampsia, Diabetes, Heart disease complicating
Pregnancy, Placenta previa.)
Active labor.
Oligohydramnios (with IUGR, not due to prelabor rupture of membranes)
Evidence of fetal distress.
Meconium stained liquor.
Chorioamnionitis.
Cord prolapse.
Preterm prelabor rupture of membranes. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine whether early induction with intravaginal cerviprime
gel or 12 hours observation for spontaneous labor followed by induction with oxytocin is
preferable in prelabor rupture of membranes at term. 
To determine whether early induction with intravaginal cerviprime
gel or 12 hours observation for spontaneous labor followed by induction with oxytocin is
preferable in prelabor rupture of membranes at term. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/02/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·         Antenatal women at term with prelabor rupture of membranes with amniotic fluid leak from cervical os is confirmed  by sterile per speculum examination under aseptic conditions are included in study after taking history and written informed consent.

·         Prophylactic antibiotics will be administered and nonstress test will be performed to know fetal wellbeing.

·         Amount of liquor will be assessed by ultrasonography.

·         The antenatal women who are not in labor are  divided into two groups by Modified bishop’s score. Patients who are fulfilling inclusion criteria are selected and seggregated into two groups after counselling, based on their will.

·         In group A, they will be induced immediately within 6hours of prelabor rupture of membranes with intravaginal instillation of 0.5mg Prostaglandin E2 gel into posterior fornix. If bishop’s score doesnot improve after 6hours then application of  Prostaglandin E2 gel is repeated maximum of two doses. After two doses of Prostaglandin E2 gel, labor augmentation will be done with oxytocin.

·         In group B, the patients included are those with prelabor rupture of membranes with duration morethan or equal to 6 hours. They will be observed for 12hours for spontaneous onset of labor, if patient fails then induction or augmentation with intravenous oxytocin drip is started, 5U in 500ml ringer lactate solution in primigravida and 2.5U in 500ml ringer lactate solution in multiparous women with infusion rate of 4 drops per min. The rate of infusion is doubled every 20mins until the occurrence of  4 contractions lasting for 45 seconds in 10mins, upto maximum infusion rate of 32mIU/min.

·         Both groups are closely monitored by:

               Temperature recording 4th hourly.

               Maternal tachycardia.

               Uterine contractions.

               Fetal heartrate auscultation every 30mins.

 


 
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