| CTRI Number |
CTRI/2025/04/083782 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring the impact of gestational age on maternal and perinatal outcomes . A comparison between term and late term pregnancies. |
|
Scientific Title of Study
|
A Comparative study to asses Maternal and Perinatal outcomes in Term pregnancies versus Late term pregnancies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pydi Saroja |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Department of obstetrics and Gynaecology,room no:S-7,Radhika bai hostel , Jawaharlal Nehru medical college , Sawangi ,meghe , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8106188688 |
| Fax |
|
| Email |
sarojasrinivas95105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepika Dewani |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical college |
| Address |
Jawaharlal Nehru Medical College ,Datta Meghe institute of higher education and research, Sawangi , meghe , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503278979 |
| Fax |
|
| Email |
deepika.d3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepika Dewani |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College |
| Address |
Department of obstetrics and gynaecology,JNMC, Datta meghe institute of higher education and research, Sawangi meghe , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9503278979 |
| Fax |
|
| Email |
Deepika.d3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of higher education and research, Sawangi, Meghe, Wardha , Maharashtra, India. PIN No-442001 |
|
|
Primary Sponsor
|
| Name |
Pydi Saroja |
| Address |
Department of Obstetrics and Gynecology,
Jawaharlal Nehru medical college
Datta Meghe Institute of Higher education and research ,
Sawangi meghe Wardha (Maharashtra) |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pydi Saroja |
Acharya Vinoba Bhave Rural Hospital |
Ward No 11 , Department of obstetrics and gynaecology,AVBRH, Sawangi, Meghe , Wardha ,India. PIN No-442001
Wardha
MAHARASHTRA |
8106188688
Sarojasrinivas95105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O481||Prolonged pregnancy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
none |
none |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Women who can recall their LMP accurately for at least three regular periods prior to conception.
2. Individuals who did not take an oral contraceptive pill for three months or longer before becoming pregnant.
3. Singleton pregnancies.
4. Cephalic presentation.
5. Age range of 18-35 years.
6. Women with first trimester scan available for calculation of estimated date of delivery .
7. Those women who met above mentioned criteria who got admitted in labor ward (booked elsewhere) were also included in the study. |
|
| ExclusionCriteria |
| Details |
1 Multiple pregnancies
2 Non cephalic presentation of the fetus
3. Congenital anomalies of the fetus
4. Post cesarean pregnancy
5. Antepartum hemorrhage
6. Pre labor rupture of membranes
7. Pregnancies complicated by placenta previa and abruptio placenta.
8. Rh Negative complicating pregnancy.
9.Medical disorders complicating pregnancy like diabetes, cardiac disease, renal disease, chronic Hypertension and pregnancy complications like preeclampsia and Gestational Diabetes mellitus.
10. Preferred cesarean delivery .
11.Patients with poor dates (last menstrual period).
12.Patients not giving consent to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict the increase in maternal and perinatal complication rates with increase in gestation from term gestation. |
We will observe all the parameters listed in both cases and controls during their baseline visit to our hospital who has a first trimester scan available with an estimated date of delivery in 37 week or above gestational age females and then immediately post delivery day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To prevent feto maternal complication by induction of labour at 40 completed weeks gestation |
We will observe all the parameters listed in both cases & controls during their baseline visit to our hospital who has a first trimester scan available with an estimated date of delivery in 37 weeks or above gestational age females & then immediately post delivery day 1 . |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
07/04/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Abstract- Background- As the maternal and neonatal adverse out come rates varies across 5 weeks gestational age range that constitutes term .There may be increased maternal fetal and neonatal risk with increase in gestational age. therefore we need to identify the increasing risk with increasing gestational age in term deliveries. Objective 1)To compare and asses the maternal and perinatal outcomes in term v/s late term pregnancies. 2)To analyse and compare spontaneous labour rates and induction rates in term V/S late term pregnancies. 3)To evaluate the incidence of operative delivery rate. Methods - 200 term antenatal women are taken and divided into 2 groups with group A (cases) -patients with >40 weeks gestation , group B (control) - patients with 37-40 weeks of gestation and observed for maternal and perinatal outcomes . Expected Results In this study we asses the increased maternal and perinatal complications associated with late term pregnancies in comparison with term pregnancies Key words- Term pregnancies, late term pregnancies,Maternal outcomes,Perinatal outcomes,perinatal morbidity , Perinatal mortality |