Labour AnalgesiaNCT07203651
Comparison Between Diclofenac and Sterile Water Injection for Relief of Labour Associated Bachache
A study testing Sterile Water Injection and Diclofenac in people with Labour Analgesia, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Comparison of Intradermal sterile water injection with diclofenac for relief of labour associated bachache Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Labour Analgesia
- What is being tested?
- Sterile Water Injection and Diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant females in active stage of labour
Who cannot join
- females asking for epidural
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Institute of Medical Sciences
Islamabad, Punjab Province, 46604
About this study
Comparison of Intradermal sterile water injection with diclofenac for relief of labour associated bachache
- Conditions
- Labour Analgesia
- Being tested
- Sterile Water Injection, Diclofenac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile Water InjectionDrug
WE will compare effectiveness of intradermal sterile water injection with intramuscular diclofenal
DiclofenacDrug
comparing effectiveness of diclofenac with intradermal sterile water injection
| Study group | Role | What they receive |
|---|---|---|
| group receiving intradermal sterile water injection | Experimental | Not described Receives: Drug: Sterile Water Injection |
| Group receiving diclofenac injection | Experimental | Not described Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start1 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sidra Rauf, Pakistan Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203651
- Sponsor's protocol ID
- Pakistan Institute of Medical
- Status last verified
- Sep 2025
- First submitted
- 22 Jun 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Diclofenac and Sterile Water Injection for Relief of Labour Associated Bachache
- ClinicalTrials.gov ID
- NCT07203651
- Acronym / sponsor ID
- Pakistan Institute of Medical
- Conditions
- Labour Analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 2 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Intradermal sterile water injection with diclofenac for relief of labour associated bachache
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group receiving intradermal sterile water injection | Experimental | Drug: Sterile Water Injection |
| Group receiving diclofenac injection | Experimental | Drug: Diclofenac |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant females in active stage of labour
Key exclusion criteria (1 listed)
- females asking for epidural
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sterile Water InjectionWE will compare effectiveness of intradermal sterile water injection with intramuscular diclofenal | Drug | group receiving intradermal sterile water injection |
| Diclofenaccomparing effectiveness of diclofenac with intradermal sterile water injection | Drug | Group receiving diclofenac injection |
Primary outcome
Pain relief
Time frame: 6 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sterile Water Injection and Diclofenac in people with Labour Analgesia, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.