| CTRI Number |
CTRI/2024/04/065413 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
As a method to aid spontaneous labor |
|
Scientific Title of Study
|
Effectiveness of nipple stimulation technique in aiding spontaneous onset of labor in low risk primigravida |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. GEETHANJALI ADDALA |
| Designation |
MS, OBGY |
| Affiliation |
KMC, Manipal |
| Address |
Department of OBGY, Women and child block, Kasturba medical college, Tiger circle road, Madhav nagar, Manipal Kasturba medical college, Tiger circle road, Madhav nagar, Manipal Udupi KARNATAKA 576104 India |
| Phone |
9441740777 |
| Fax |
- |
| Email |
geethanjaliaddala@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR. SUJATA B.S. |
| Designation |
Associate professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of OBGY, Women and child block, Kasturba medical college, Tiger circle road, Manipal Kasturba medical college Tiger circle road, Madhav nagar, Manipal Udupi KARNATAKA 576104 India |
| Phone |
8660778169 |
| Fax |
- |
| Email |
bssujata@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR. PRATHIKSHA. K |
| Designation |
Assistant professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of OBGY, Women and child block, Kasturba medical college, Tiger circle road, Madhav nagar, Manipal Kasturba medical college, Tiger circle road, Madhav nagar, Manipal Udupi KARNATAKA 576104 India |
| Phone |
9880691709 |
| Fax |
- |
| Email |
prathiksha.k1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| Geethanjali addala |
Kasturba Hospital, Manipal |
Department of OBGY, Women and child block, Kasturba medical college, KMC, Manipal Udupi KARNATAKA |
9441740777
geethanjaliaddala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil since it is an observational study |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Low risk primigravida who completed 37weeks of gestation with cephalic presentation, and no other medical (such as diabetes, hypertension, hypothyroidism etc,) and surgical complications. |
|
| ExclusionCriteria |
| Details |
Those who have medical and surgical complications and other pregnancy related complications such as cephalo-pelvic disproportion, h/o assisted reproductive techniques and those who are not willing for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To be observed in both groups in the form of maternal, fetal outcomes. Maternal outcomes such as change in the Bishop’s score after 2 weeks, spontaneous or induced labour, Induction for post-datism, mode of delivery, duration of labour and any hyperstimulation, meconium-stained liquor
Fetal outcomes such as Apgar score at 5 mins, requirement of neonatal intensive care unit admission, neonatal morbidities like sepsis, asphyxia, jaundice, respiratory distress, fetal or neonatal death. |
at the time of recruitment |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="142" Sample Size from India="142"
Final Enrollment numbers achieved (Total)= "142"
Final Enrollment numbers achieved (India)="142" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2024 |
| Date of Study Completion (India) |
20/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
Low risk Primigravida who are at 37completed weeks of gestation, fitting the inclusion criteria will be recruited from the OPD during their routine antenatal visit to the hospital. A baseline cervical scoring using Bishop’s score will be done along with pelvic assessment and those with cephalopelvic disproportion will be excluded. These low risk pregnant women will be provided charts explaining the technique of nipple stimulation and its advantages as per the consultant’s advice. The women who are consenting for the study will be taken as stimulation group and those are not willing for the study will be taken as non- stimulation group (each with sample size of 71). This nipple stimulation is a standard method of practice in some units, as it helps in cervical ripening and timely onset of labour without use of any pharmacological means. These women will be followed weekly in their regular weekly antenatal follow up. No extra visits will be required for this study. They will be advised to keep a daily dairy of the manoeuvre and to be shown in the subsequent visit. At 39weeks, these women are to be followed up and those who has not done the manoeuvre will be excluded from the study. A repeat Bishop’s score has to be done at 39+ weeks of gestation, and changes in the cervical scoring to be noted in both the groups. These women will be advised to attend immediately to the obstetric casualty in case of pain abdomen associated with tightening, leaking or bleeding PV or decreased fetal movements. |