| CTRI Number |
CTRI/2024/10/074971 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study between two different ultrasonography parameters of amniotic fluid assessment in women with term pregnancy with their foetal outcome |
|
Scientific Title of Study
|
Correlation of single deepest vertical pocket of amniotic fluid and amniotic fluid index at term with foetal outcome |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shefali Singh |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha |
| Address |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9758275507 |
| Fax |
|
| Email |
singhshefali1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandhya Pajai |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha |
| Address |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9823686669 |
| Fax |
|
| Email |
sandhyapajai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shefali Singh |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha |
| Address |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9823686669 |
| Fax |
|
| Email |
singhshefali1996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra, India, Pincode: 442001 |
| Type of Sponsor |
Private 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 Shefali Singh |
Acharya Vinoba Bhave Rural Hospital |
Department of Obstetrics and Gynaecology, Jawaharlal Nehru Medical College, Sawangi Meghe
Wardha
MAHARASHTRA |
9758275507
singhshefali1996@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: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amniotic fluid index measurement |
In the group assigned to AFI measurement, the AFI will be calculated by dividing the uterine cavity into four quadrants. Considering the umbilicus as the reference point, the uterus will be divided into an upper and lower half. Subsequent division of uterus into right and left halves will result in four uterine quadrants. The ultrasound transducer will be placed in each quadrant with the probe held in the longitudinal axis of the mother at a right angle to the floor. In each quadrant the largest vertical diameter of the fluid pocket (not containing small foetal parts or loops of umbilical cord) will be recorded by the above technique. The sum of these four quadrant values in centimetres will be regarded as the AFI value. This would be done at the time of admission in term patients |
| Intervention |
Single Deepest Vertical Pocket measurement |
In the group assigned to SDVP measurement, only the largest diameter of the fluid pocket will be measured. The deepest pocket of amniotic fluid free of umbilical cord will be detected with the ultrasound probe held perpendicular to the maternal abdominal wall. Vertical and transverse diameters of this pocket will be measured. The deepest vertical diameter of the pocket which has a transverse diameter of at least 1 cm will be considered as SDVP value. This would be done at the time of admission in term patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. At term pregnant women with gestational age of 37 to 40 weeks with amniotic fluid assessment done in last 7 days
2. Singleton pregnancy with cephalic presentation
3. Confirmed period of gestation by an ultrasound scan performed in first trimester of pregnancy
Â4. Intact membranes without rupture on admission to labour room
5. Those patients who are willing to get enrolled in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients with previous Cesarean section.
2. History of gestational hypertension and/or diabetes mellitus, multiple gestation, premature rupture of the membranes, placenta previa or any other placental anomaly, polyhydramnios, bad obstetrical history, antepartum haemorrhage
3. Structural or chromosomal foetal malformation, intrauterine growth restriction, intrauterine foetal death, RH incompatibility
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postpartum admission to neonatal intensive care unit
|
Admission will be done at the time of admission. The study will be carried for a period of 2 years.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Apgar score at birth and at 5 minutes
2. Incidence of oligohydramnios
3. Maternal and fetal factors associated with oligohydramnios
4. Maternal and Obstetrics characteristics
5. Reliability and reproducibility of measurement techniques
|
Assessment will be done at the time of admission. The study will be carried for a period of 2 years |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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="2"
Months="0"
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
|
Amniotic fluid assessment plays a crucial role in managing pregnancy, with various techniques available to evaluate amniotic fluid volume. Among these techniques, the single deepest vertical pocket (SDVP) measurement and amniotic fluid index (AFI) are commonly used in clinical practice. However, there is limited evidence comparing the predictive value of these two methods for fetal outcomes in term pregnancies. This study aims to compare SDVP measurement with AFI in term pregnancy and assess their correlation with fetal outcomes, particularly the need for neonatal intensive care unit (NICU) admission.
Material and Methods: This randomized controlled trial will be conducted at the Department of Obstetrics & Gynecology, AVBRH, DMIHER, over two years. 150-term pregnant women will be enrolled and randomly allocated to the SDVP or the AFI measurement group. Demographic data, obstetric history, and baseline characteristics will be collected at enrollment. Based on their allocated group, participants will undergo ultrasound examinations to measure SDVP or AFI. Followup will occur throughout pregnancy, labor, and postpartum, with neonatal outcomes assessed, including Apgar scores and NICU admission. Statistical analysis will involve descriptive statistics, inferential statistics, and multivariable regression analysis to assess the association between the allocated intervention and fetal outcomes.
Expected Outcome: We anticipate the study will provide valuable insights into the comparative effectiveness of SDVP measurement and AFI in predicting fetal outcomes in term pregnancies. We hypothesize that SDVP measurement may offer comparable or superior predictive value compared to AFI for identifying pregnancies at increased risk of adverse fetal outcomes, such as NICU admission. The findings of this study may have implications for clinical practice by informing obstetricians and healthcare providers about the optimal method for amniotic fluid assessment in term pregnancies, ultimately improving perinatal care and neonatal outcomes. |