NCT07203651

Brief Summary

Comparison of Intradermal sterile water injection with diclofenac for relief of labour associated bachache

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jan 2025Jul 2026

Study Start

First participant enrolled

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

June 22, 2025

Last Update Submit

September 24, 2025

Conditions

Labour Analgesia

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    relief of labour associated bachache using visual analogue pain scale. Scale is from 0 to 10 score. Score 0 means no pain and Score 10 keans worst possible pain. 1-2 Score: Mild pain 3-4 score: moderate pain 5-6 score: severe pain 7-8 score: very severe 9-10: worst pain possible Having lower scores means better outcome in terms of pain relief

    6 months

Study Arms (2)

group receiving intradermal sterile water injection

EXPERIMENTAL
Drug: Sterile Water Injection

Group receiving diclofenac injection

EXPERIMENTAL
Drug: Diclofenac

Interventions

Sterile Water InjectionDRUG

WE will compare effectiveness of intradermal sterile water injection with intramuscular diclofenal

group receiving intradermal sterile water injection
DiclofenacDRUG

comparing effectiveness of diclofenac with intradermal sterile water injection

Group receiving diclofenac injection

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant females
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant females in active stage of labour

You may not qualify if:

  • females asking for epidural

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Punjab Province, 46604, Pakistan

Location

MeSH Terms

Interventions

Diclofenac

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate resident

Study Record Dates

First Submitted

June 22, 2025

First Posted

October 2, 2025

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations

PA(1)