| CTRI Number |
CTRI/2023/06/053371 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
07/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preterm Caesarean delivery in Hypertensive disorders of pregnancy. |
|
Scientific Title of Study
|
Hypertensive disorders of pregnancy as determinant of caesarean delivery in Robson group 10.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Pandey |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital
MG Road,Delhi-110029
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Pandey |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital
MG Road,Delhi-110029
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
dr_devya1@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr DR PHAIREMBAM SUNANDA SINGH |
| Designation |
Postgraduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital
MG Road,Delhi-110029
South West
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
creator0687@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital,Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung hospital |
| Address |
MG Road
Delhi-110029 |
| 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 divya pandey |
VMMC and Safdarjung Hospital |
Department of Obstetrics and Gynaecology,VMMC and Safdarjung Hospital,Delhi-110029
South West
DELHI |
8860198440
dr_devya1@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe,VMMC and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Women with Singleton Pregnancy < 37 weeks of gestation with Cephalic presentation. |
|
| ExclusionCriteria |
| Details |
-Multiple gestation.
-Antenatal women not expected to deliver before 37 weeks of gestation.
-Malpresentation.
-Preterm vaginal delivery (<37weeks). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Number of women with Hypertensive Disorders of Pregnancy in Robson group 10 undergoing Caesarean Delivery.
2.Association between hypertensive disorders of pregnancy & caesarean delivery in Robson group 10. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other determinants (than Hypertensive disorders of pregnancy) for Cesarean section in Robson gp 10 |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="550"
Sample Size from India="550"
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)
|
09/06/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background and purpose of the studyHypertensive disorders of pregnancy (HDP) constitute one of the leading causes of maternal and perinatal mortality worldwide. The mode of delivery in women with HDP should be guided by routine obstetric indications. Vaginal delivery is preferred for gestational hypertension or preeclampsia without severe features.Though vaginal delivery is achieved in most cases of HDP, but in preeclampsia with severe features ,vaginal delivery is often not accomplished as the gestational age decreases.The occurrence of delivery by caesarean section at less than 28 weeks of gestation may go upto 97%, and between 28–32 weeks of gestation, it goes upto 65% as per the existing literature. The decision to perform cesarean delivery should be individualized. Although the decision of pregnancy termination in HDP is guided primarily by maternal status, maturity of fetus and risks associated with preterm Caesarean section (CS) should also be kept in mind. Rising Cesarean section (CS) rates is now a global concern. Out of the 10 classes of Robson Ten group classification system, the most common contributor to Caesarean section is Robson group 5, followed by group 2 and group 1. The fourth contributory group is group 10 which refers to single, cephalic, less than 37 weeks of gestation(preterm). The decision of mode of delivery in preterm antenatal women is very prudent keeping in view its impact on the subsequent pregnancy outcome. Thus Robson group 10 needs to be scrutinized for the indications of caesarean delivery. With this background, the present thesis has been aimed to study Hypertensive disorders of pregnancy as determinant of Caesarean Section in Robson group 10. |