| CTRI Number |
CTRI/2024/06/068957 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of ultrasonographic parameters in the prediction of delivery period in rupture of membranes before 37 weeks of gestation |
|
Scientific Title of Study
|
Role of transvaginal cervical length and amniotic fluid index in the prediction of latency period in preterm premature 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 Prachi Juneja |
| Designation |
Post graduate Junior resident |
| Affiliation |
Government medical college and hospital ,sector 32 ,Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, D block (level 4)
Government medical college and hospital ,sector 32 B ,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
6283165197 |
| Fax |
|
| Email |
prachijuneja0001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjeet kaur |
| Designation |
Assistant professor |
| Affiliation |
Government medical college and hospital ,sector 32 ,Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, D block (level 4)
Government medical college and hospital ,sector 32 B ,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646004686 |
| Fax |
|
| Email |
drmanjeetkaur99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjeet kaur |
| Designation |
Assistant professor |
| Affiliation |
Government medical college and hospital ,sector 32 ,Chandigarh |
| Address |
Department of Obstetrics and Gynaecology, D block (level 4)
Government medical college and hospital ,sector 32 B ,Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646004686 |
| Fax |
|
| Email |
drmanjeetkaur99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and hospital, Sector 32 B ,
Chandigarh, India. Pincode:160030 |
|
|
Primary Sponsor
|
| Name |
Government medical college and hospital Chandigarh |
| Address |
Sector 32 B,
Chandigarh, India.
Pincode:160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Prachi Juneja |
Government medical college and hospital |
Department of Obstetrics and Gynaecology, D-block (level 4)
Sector 32 B ,Chandigarh, India.
Pincode:160030
Chandigarh
CHANDIGARH |
6283165197
prachijuneja0001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (GMCH, Chandigarh) |
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 |
| Intervention |
Not applicable |
Not applicable |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
A singleton pregnancy of gestational age between 28 weeks to 36+6 weeks with preterm premature rupture of membranes (PPROM) presenting with less than 72 hours of leaking |
|
| ExclusionCriteria |
| Details |
1 Those in active labor
2 Women with chorioamnionitis
3 Multifetal pregnancy
4 Malpresentation
5 Antepartum hemorrhage
6 Cervical cerclage operation
7 Congenital uterine malformation, previous uterine scar
8 Severe fetal growth restriction
9 Patients requiring immediate termination of pregnancy such as severe pre-eclampsia, eclampsia and NYHA grade 3 and 4 cardiac disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the role of transvaginal cervical length and amniotic fluid index in patients with PPROM between 28 weeks to 36+6 weeks in predicting the delivery latency period |
Baseline and after 3-5 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the maternal and neonatal outcomes in patients with PPROM between 28 weeks to 36+6 weeks. |
After 3-5 days |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
01/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients presenting with preterm premature rupture of membranes (PPROM) between 28 weeks to 36+6 weeks of gestation fulfilling the inclusion and exclusion criteria will be enrolled in the study after taking written informed consent. All the women after admission will be subjected to detailed history including demographic information, maternal parameters like parity, maternal age at the time of admission, gestational age at the time of presentation, obstetric history, menstrual history, past history and family history will be documented. Gestational age will be calculated by last menstrual period or early trimester scan. General physical examination, systemic examination and per abdomen examination will be performed which includes assessment of fundal height, lie of the fetus and presentation of the fetus. We will also assess for contractions, abdominal tenderness and localisation of fetal heart using stethoscope. PPROM will be clinically confirmed by performing a sterile per speculum examination under all aseptic condition (presence of amniotic fluid coming out through cervical os will be noted) and using Litmus paper to check the pH of cervicovaginal secretions. Routine investigations will be done at the time of admission in all subjects which includes haemoglobin, total leukocyte count (TLC), differential leukocyte count(DLC), C-reactive protein(CRP), urine routine microscopy , urine culture sensitivity and a high vaginal swab will be taken .A transabdominal ultrasound will be done in all subjects at the time of admission for determining cardiac activity, fetal biometry, estimated fetal weight, placental localization and liquor. For estimation of amniotic fluid index, abdomen is divided into four compartments and each of the deep cord free vertical pockets of liquor is taken and sum up. After emptying the bladder, transvaginal ultrasound will be done to measure cervical length. Transvaginal cervical length (TVCL) measurement will be done by placing the callipers between external and internal cervical os. All the admitted patients will be put on expectant management, which includes administration of antibiotics and corticosteroids. Maternal and fetal monitoring will be done as per protocol which includes monitoring of signs and symptoms of sepsis, pulse rate, temperature, offensive vaginal discharge, uterine tenderness, fetal heart rate monitoring. Total leucocyte count (TLC), differential leucocyte count (DLC) and C-reactive protein(CRP) will be monitored after every 72 hours till delivery and once after delivery also. Serial USG measurement of amniotic fluid index (AFI) will be done after every 72 hours for better fetal outcome. For the purpose of analysis, each parameter will be divided into mainly two groups that is latency ≤ 7 days and > 7 days , amniotic fluid index (AFI) < 5cms and > 5 cms and transvaginal cervical length (TVCL) < 3 cms and > 3 cms. The primary endpoint will be prediction of delivery latency period based on the admission values of transvaginal cervical length (TVCL) and amniotic fluid index (AFI) in cases with preterm premature rupture of membranes. OUTCOME MEASURES : By taking the admission values of transvaginal cervical length and amniotic fluid index into account in patients with preterm premature rupture of membranes between 28 weeks to 36+6 weeks, we will predict the delivery latency period. Following the delivery of the baby, maternal and neonatal outcomes will be studied. Both mother and baby will be followed up till their stay in the hospital. |