| CTRI Number |
CTRI/2023/12/060836 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Outcomes of induction of labour in pregnancy |
|
Scientific Title of Study
|
Association of plasma leptin levels with outcome of induction of labour in pregnant women |
| 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 PRIYA LAL |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
ANSARI NAGAR WEST, NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
9971855774 |
| Fax |
|
| Email |
priyalal.8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Lal |
| Designation |
Post graduate resident doctor |
| Affiliation |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
09971855774 |
| Fax |
|
| Email |
priyalal.8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Gupta |
| Designation |
Professor, Department of Obstetrics and Gynaecology |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital
New Delhi
DELHI
110029
India |
| Phone |
9312796171 |
| Fax |
|
| Email |
drmonikagupta@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital
Ansari Nagar West
New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
Dr Priya Lal |
| Address |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Type of Sponsor |
Other [SELF] |
|
|
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 Priya Lal |
Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital |
Ansari Nagar West, New Delhi- 110029
New Delhi
DELHI |
9971855774
priyalal.8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhman Mahavir Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O619||Failed induction of labor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
All antenatal women at more than or equal to 37 weeks of gestation who have undergone induction of labour by any method (misoprostol, dinoprostone, PGE2 gel, oxytocin, artificial rupture of membranes, membrane stripping or Foley’s balloon placement) |
|
| ExclusionCriteria |
| Details |
Multiple gestation
Fetal anomalies
Augmentation of labour rather than induction of labour
Intrauterine fetal death
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Maternal plasma Leptin levels
2.Success or failure of Induction of labour
3.Mode of delivery
4.Fetal birth weight
5.Fetal APGAR
6.Admission to NICU
7.Administration of neonatal antibiotics
|
From 37 weeks POG till 2 weeks postnatally
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Fetal birth weight
2.Fetal APGAR
3.Admission to NICU
4.Administration of neonatal antibiotics
|
From 37 weeks POG till 2 weeks postnatally
|
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="180" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2024 |
| Date of Study Completion (India) |
30/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Maternal obesity is associated with a significant increase in the incidence of miscarriage, congenital anomalies, macrosomia, gestational diabetes, gestational hypertension, preeclampsia and stillbirth. Leptin is an important biomarker responsible for the regulation of energy homeostasis. It has regulatory effects on neuronal tissue, vascular smooth muscle, and nonvascular smooth muscle systems . Placenta is also a major source of leptin production during pregnancy. Leptin has been identified as an independent predictor of dysfunctional labor and is associated with increased risk of failed induction of labor resulting in cesarean section.It may play an important role in dysfunctional labor and be associated with the outcome of induction of labor at term. Our aim is to determine whether maternal plasma leptin concentration is indicative of the outcome of induction of labor at term. We hypothesize that elevated maternal plasma leptin levels are associated with a failed term induction of labor resulting in a cesarean delivery.
Ref - Cowman, W., Scroggins, S.M., Hamilton, W.S. Association between plasma leptin and cesarean section after induction of labor: a case control study. BMC Pregnancy Childbirth, Article no. 29. 2022 |