| 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
|
|
|
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. |