| CTRI Number |
CTRI/2024/07/071623 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of WHO labour care guide and modified partograph in labour outcomes in pregnant mothers. |
|
Scientific Title of Study
|
Comparison of WHO labour care guide with modified partograph on labour outcomes at a tertiary centre in North East India- A Randomized control 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 |
Parakh Mittal |
| Designation |
Post graduate trainee |
| Affiliation |
Agartala Government medical college and GB hospital |
| Address |
Department of Obstetrics and Gynecology AGMC and GBPH Kunjaban Agartala
West Tripura
TRIPURA
799006
India |
| Phone |
7619344285 |
| Fax |
|
| Email |
parakhm03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SB Chakrabarti |
| Designation |
Associate Professor |
| Affiliation |
Agartala Government medical college and GB hospital |
| Address |
Department of Obstetrics and Gynecology AGMC and GBPH Kunjaban
West Tripura
TRIPURA
799006
India |
| Phone |
9436131634 |
| Fax |
|
| Email |
salilbindu64@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Debasis Ray |
| Designation |
Professor |
| Affiliation |
Agartala Government medical college and GB hospital |
| Address |
Department of Pharmacology AGMC and GBPH Kunjaban Agartala
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
|
Source of Monetary or Material Support
|
| Agartala Government medical college AGMC and GBP Hospital kunjaban Agartala pin code-799006 India |
|
|
Primary Sponsor
|
| Name |
Parakh Mittal |
| Address |
Department of Obstetrics and Gynecology AGMC and GBPH Kunjaban Agartala |
| 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 Parakh Mittal |
Agartala Government medical college and GBP Hospital |
Department of Obstetrics and Gynecology
West Tripura
TRIPURA |
7619344285
parakhm03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Clinical Studies Ref. No.F.4(6-13)/AGMC/Medical Education/IEC Approval/2022/6995 |
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, (2) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, (3) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, (4) ICD-10 Condition: O30-O48||Maternal care related to the fetus and amniotic cavity and possible delivery problems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Labour monitoring to be done by WHO Labour care guide |
Labour monitoring will be done every half hourly and PV examination will be done 4 hourly from active stage of labour till the delivery |
| Comparator Agent |
Labour monitoring will be done by WHO Modified partograph |
Labour monitoring will be done every half hourly and PV examination will be done 4 hourly from active stage of labour till delivery |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Antenatal women with term gestation between 37 and 40 weeks gestation
2) In spontaneous labour
3) Singleton pregnancy
|
|
| ExclusionCriteria |
| Details |
1) Women with any medical comorbidities such as hypertension , diabetes mellitus, renal or pulmonary diseases
2) Women with any obstetrical complication like preterm, multiple gestation, breech , post dated pregnancy or bad obstetrical history
3) Those who were given intrapartum epidural analgesia
4) Any other contraindications of normal vaginal delivery
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Normal vaginal delivery |
Mode of delivery will be assessed after 6-7 hours and APGAR score at 5 minutes after birth |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Duration of active phase of labour
2) Duration of hospital stay
3) APGAR score at 5 minutes
4) Proportion of NICU admission |
2-3 Days |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
Final Enrollment numbers achieved (Total)= "240"
Final Enrollment numbers achieved (India)="240" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
14/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
This study is regarding comparison of WHO Labour care guide with Modified partograph on labour outcomes. This will be conducted by making two study groups . A sample size of 240 participants will be selected randomly after considering inclusion and exclusion criteria for labour monitoring by either of the two labour monitoring tools. The following outcomes will be analyzed in each group Primary outcome- normal vaginal delivery Secondary outcome- duration of active phase of labour, duration of hospital stay, fetal profile- APGAR score at 5
Dated- 30/01/2025 Till now 51 participants have been recruited . 26 in study group A and 25 in study group B and no issues have been encountered yet. Hence this interventional study will be continued as it is and will be updated after every 6 months.
Dated- 28/07/2025 Till now 196 participants have been recruited. 96 in study group A and 100 in study group B and no issues have been encountered yet. Hence this interventional study will be continued as it is and will be updated again soon.
Dated- 12/10/2025 All 240 participants are recruited successfully including both the study groups. Now we shall proceed with analysis and result.
Dated- 14/01/2026 study has been analyzed and result is obtained. |