Labour DurationNCT07394491
Intravenous Paracetamol Versus Intramuscular Tramadol in Shortening the Duration of Labour.
A study testing paracetamol and Tramadol hydrochloride in people with Labour Duration, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
Trial summary
It is a well established fact that the pain of labour can be excrutiating and ways to shorten the duration of labour has been sought after. this study compares the role of intramuscular tramadol and intravenous paracetamol in shortening the duration of labour Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Duration
- What is being tested?
- paracetamol and Tramadol hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteNigeria
- Study dates
- 1 Nov 2022to 25 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Spontaneous active phase labour
- No contraindication to vaginal delivery
Who cannot join
- Clinical evidence of cephalopelvic disproportion
- Malpresentation,
- Multiple pregnancy,
- Previously scarred uterus,
- Preterm labour,
- Induced labour
Show all 12Show fewer
- Antepartum hemorrhage.
- History of known allergy to tramadol and paracetamol or opioids or
- History of narcotics dependency.
- History of renal disease,
- Fetal distress
- Intrauterine fetal death.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Paracetamol Versus Intramuscular Tramadol in Shortening the Duration of Labour: a Randomized Controlled Trial
It is a well established fact that the pain of labour can be excrutiating and ways to shorten the duration of labour has been sought after. this study compares the role of intramuscular tramadol and intravenous paracetamol in shortening the duration of labour
Read the detailed description
Background: The excruciating pain associated with labour as led to different studies aimed at finding pharmacolologic and non pharmacologic ways of shortening the duration of labour. Most agents used are either expensive or associated with fetomaternal adverse effects. This has led to the study of paracetamol and tramadol that have analgesic properties and have shown to have effect on labour duration.
Aim: To compare intravenous paracetamol versus intramuscular tramadol in shortening the duration of labour at Alex Ekwueme Federal University Teaching Hospital and St Patrick's Mile 4 Hospital, Abakaliki, Ebonyi State.
Methodology: It is an open label, non inferiority randomized controlled trial that was conducted on one hundred and eighty-nine parturients in active labour. Group A received 1000mg of intravenous paracetamol while Group B received 100mg of intramuscular tramadol and allocation was in the ratio of 1:1. Labour duration in the active phase was noted. Data were analyzed using SPSS version 25.
- Conditions
- Labour Duration
- Being tested
- paracetamol, Tramadol hydrochloride
- Keywords
- Labour duration, intramuscular tramadol, intravenous paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamolDrug
Also called acetaminophen
1000 mg of paracetamol was administered intravenously to participants in active phase of labour
Tramadol hydrochlorideDrug
Also called tramadol
100mg of tramadol given in active phase of labour
| Study group | Role | What they receive |
|---|---|---|
| intramuscular tramadol | Active comparator | 100mg of tramadol was given intramuscularly in active phase of labour Receives: Drug: Tramadol hydrochloride |
| paracetamol | Experimental | 1000mg of paracetamol given intravenously in active phase of labour Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean duration of first, second and third stage of labour
the mean of the different stages of labour as well as the total duration of labour
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start1 Nov 2022
- Primary completion25 Feb 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour DurationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki
- Investigators
- Assumpta N Nweke, Principal investigator, ST Patrick Mission Hospital, Mile $ Abakaliki, Ebonyi State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394491
- Sponsor's protocol ID
- RE/M4H/86/22
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Paracetamol Versus Intramuscular Tramadol in Shortening the Duration of Labour: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07394491
- Acronym / sponsor ID
- RE/M4H/86/22
- Conditions
- Labour Duration
- Keywords
- Labour duration, intramuscular tramadol, intravenous paracetamol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 6 Feb 2026 (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.
It is a well established fact that the pain of labour can be excrutiating and ways to shorten the duration of labour has been sought after. this study compares the role of intramuscular tramadol and intravenous paracetamol in shortening the duration of labour
Detailed description
Background: The excruciating pain associated with labour as led to different studies aimed at finding pharmacolologic and non pharmacologic ways of shortening the duration of labour. Most agents used are either expensive or associated with fetomaternal adverse effects. This has led to the study of paracetamol and tramadol that have analgesic properties and have shown to have effect on labour duration.
Aim: To compare intravenous paracetamol versus intramuscular tramadol in shortening the duration of labour at Alex Ekwueme Federal University Teaching Hospital and St Patrick's Mile 4 Hospital, Abakaliki, Ebonyi State.
Methodology: It is an open label, non inferiority randomized controlled trial that was conducted on one hundred and eighty-nine parturients in active labour. Group A received 1000mg of intravenous paracetamol while Group B received 100mg of intramuscular tramadol and allocation was in the ratio of 1:1. Labour duration in the active phase was noted. Data were analyzed using SPSS version 25.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intramuscular tramadol | Active comparator | Drug: Tramadol hydrochloride100mg of tramadol was given intramuscularly in active phase of labour |
| paracetamol | Experimental | Drug: paracetamol1000mg of paracetamol given intravenously in active phase of labour |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Spontaneous active phase labour
- No contraindication to vaginal delivery
Key exclusion criteria (12 listed)
- Clinical evidence of cephalopelvic disproportion
- Malpresentation,
- Multiple pregnancy,
- Previously scarred uterus,
- Preterm labour,
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 |
|---|---|---|
| paracetamolAlso: acetaminophen1000 mg of paracetamol was administered intravenously to participants in active phase of labour | Drug | paracetamol |
| Tramadol hydrochlorideAlso: tramadol100mg of tramadol given in active phase of labour | Drug | intramuscular tramadol |
Primary outcome
Mean duration of first, second and third stage of labour
Time frame: 12 hours
the mean of the different stages of labour as well as the total duration of labour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Assumpta N Nweke principal investigator
ST Patrick Mission Hospital, Mile $ Abakaliki, Ebonyi State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paracetamol and Tramadol hydrochloride in people with Labour Duration, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 6 Feb 2026. 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 Nigeria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean duration of first, second and third stage of labour (time frame: 12 hours). 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 6 Feb 2026.