| CTRI Number |
CTRI/2025/05/087646 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
18/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [exercise on birthing ball] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effect of exercises on birthing ball during active labor |
|
Scientific Title of Study
|
The effect of exercises performed on birthing ball on labor pain and duration of labor- A Randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Singh |
| Designation |
Junior Resident |
| Affiliation |
Aiims patna |
| Address |
Room no. 244, OPD building, OBSTERTICS AND GYNAECOLOGY department, Aiims Patna, Bihar
obg department, Aiims Patna,
Patna
BIHAR
801507
India |
| Phone |
08429741304 |
| Fax |
|
| Email |
Akanksha2802singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Monika Anant |
| Designation |
professor |
| Affiliation |
Aiims patna |
| Address |
Room no. 250, OPD building, OBSTERTICS AND GYNAECOLOGY department, Aiims Patna, Bihar
obg department, Aiims Patna, Bihar
Patna
BIHAR
801507
India |
| Phone |
7764946249 |
| Fax |
|
| Email |
drmonikaa@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Akanksha Singh |
| Designation |
Junior Resident |
| Affiliation |
Aiims patna |
| Address |
Room no. 244, OPD building, OBSTERTICS AND GYNAECOLOGY department, Aiims Patna, Bihar
OBSTERTICS AND GYNAECOLOGY department, Aiims Patna, Bihar
Patna
BIHAR
285001
India |
| Phone |
08429741304 |
| Fax |
|
| Email |
Akanksha2802singh@gmail.com |
|
|
Source of Monetary or Material Support
|
| OBSTERTICS AND GYNAECOLOGY department, Aiims Patna, Bihar OBSTERTICS AND GYNAECOLOGY department, Aiims Patna, Bihar , Pin code-801507 |
|
|
Primary Sponsor
|
| Name |
Akanksha Singh |
| Address |
Room no 244, OPD building, OBSTERTICS AND GYNAECOLOGY department, Aiims Patna, Bihar, Pin code- 801507 |
| 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 Akanksha Singh |
AiimsPatna |
Labor room (B1A ward),IPD 1st floor, AiimsPatna campus,Bihar,pin-801507
Patna
BIHAR |
8429741304
Akanksha2802singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Birthing ball exercises |
intervention group includes primiparous antenatal women at term will receive supplementary birthing ball exercies during active stage of labor along with routine care for duration of 15 min with an interval of 45min for 4 cycles. |
| Comparator Agent |
no intervention, only recieve routine care as control group |
comparator group includes primiparous antenatal women at term wil receive only routine care during active stage of labor. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.primigravida antenatal women at term POG(37-42week) singleton pregnancy with cephalic presentation.
2.primigravida at term who are in active stage of labor.
3. undergone labor spontaneously / by induction.
3.willing to participate in study. |
|
| ExclusionCriteria |
| Details |
1.Patient not giving consent
2.Maternal complications (Oligohydramnios, Polyhydramnios, Placenta previa, Preeclampsia, PROM, Inadequate pelvis, physical abnormality, chronic pelvic pain).
3.Fetal complication ( Malpresentation, IUGR, fetal anomaly, intrauterine death, fetal macrosomia, fetal distress)
4.Elective and Emergency cesarean section in 1st stage of labor
5.Having any complications that prevent vaginal delivery, having any extremity problems for using the birth ball and performing activities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To compare intensity of labor pain during active stage of labor at 5cm and at 9cm using Visual Analog Scale (VAS) among the two groups ( one whom intervention will be used and one without intervention.)
|
during active stage of labor at 5cm and at 9cm using Visual Analog Scale (VAS)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the duration of the active stage of labor using labor care guide in both group of patient |
duration of active stage of labor (from 5cm to 10cm cervical dialatation ) |
| To compare subjective outcomes of childbirth experience using Childbirth Experience Questionaire 2( CEQ-2 ) between the two groups |
after delivery of baby |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
29/05/2025 |
| 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="1"
Months="0"
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
|
This study is a non randomised control trial to find out the effect of
exercises performed on birthing ball on labor pain and duration of labor in
active phase of labor among primiparous anternatal women at term, who will be
admit in AIIMS PATNA labor ward. Labour pain can be extremely intense and
prolonged, making them challenging for many women to endure without medical
intervention or support. Birthing ball can be a effective non
pharmacological method of pain relief during labor without side effect
and would have better outcomes for both mother and baby. Birthing ball
exercises by its impact on pelvic structure/dimension may help in fetal descent
and cervical dilatation, and will significantly reduce maternal pain in labor
and reduce labor duration. Informed consent will be obtained from antenatal
women before conduction of study. This study will be done in 74 primiparous
antenatal women at term (37-42week POG) with singelton pgegnancy with cephalic
presentation in active stage of labor. patient will be randomised between 2
group intervention and control group.Intervention group recieve birthing
ball exercise (4cycle of 15 min exercise at an interval of 45 min) as well
as routine care and control group will recieve only routine care. Exercises
include- 3 Simple exercises – bouncing on ball, rocking left to
right , hip circles. Outcome will be measured by visual analogue scale (VAS) for pain during
labor at 2 time points (at 5cm, and 9 cm cervical dilatation ) as primary
outcome, determining the length of labor by measuring cervical dilatation
using partograph (WHO labor care guide)and measure
subjective outcome of childbirth
satisfaction using childbirth experience questionnaire
(CEQ2) as secondary outcome.
|