Labor PainNCT04744727
Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain
A study testing paracetamol-pethidine in people with Labor Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- paracetamol-pethidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 10 May 2020
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primiparous
- aged 18-35 years,
- Term live singleton pregnancy,
- Vertex presentation,
- Spontaneous onset of labor at term 37-42 weeks gestation,
- In active phase of of 1st stage of labour (cervix dilatation 3- 4 cm).
Who cannot join
- Clinical evidence of cephalopelvic disproportion
- Use of any kind of analgesia prior to study
- Any medical disorder during pregnancy (liver or kidney impairment)
- Induction of labor, Intrauterine fetal death
- Evidence of fetal distress
- Antenatal diagnosis of congenital malformation
Show all 10Show fewer
- Previous history of hypersensitivity to either drug
- Extremes of age (i.e. below 18 or above 35)
- Multiple pregnancies
- Cervical dilatation more than 6 cm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain in a Low Resource Setting
to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains
Read the detailed description
investigators conducted a randomized clinical study included including 96 primiparous women admitted to Obstetrics and Gynecology Department, Menoufia University Hospitals, starting the study from May 2019 to March 2020 to assess the use of paracetamol intravenously versus Pethidine HCL intravenously in management of intrapartum pain. After obtaining approval from the local ethics committee, women who agreed to participate gave their signed informed consent after explanation of the trial benefits and hazards
- Conditions
- Labor Pain
- Being tested
- paracetamol-pethidine
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paracetamol-pethidineDrug
100 ml containing 1000 mg paracetamol -50 mg pethidine HCL
| Study group | Role | What they receive |
|---|---|---|
| paracetamol group | Active comparator | Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. Receives: Drug: paracetamol-pethidine |
| pethidine group | Active comparator | Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. Receives: Drug: paracetamol-pethidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the intensity of perceived labor pain.
Labour pain was semi-objectively assessed using the visual analogue scale (VAS). In this technique, the patient is shown a ten cm line which represent at one end no pain and the other worst pain, and the patient is asked to point on the line where her pain lies. This scale has the added advantage that the pain can be given a numerical value.
Measured: immediately after the intervention and up to 3 hours after the intervension
Secondary outcomes (9)
duration of the active phase of the 1st stage of labor
Measured: immediately from start of active phase of the 1st stage of labor till the end of first stage
duration of the 2nd stage of labor
Measured: immediately from start of second stage till deliver of fetus
need for further analgesia
Measured: immediately after the intervention till the end of first stage of labour
maternal dizziness, nausea and/or vomiting
Measured: immediately after the intervention till the end of first stage
mode of delivery (vaginal or by caesarian
Measured: immediately after the intervention
1- and 5-minutes Apgar scores.
Measured: immediately after delivery of the fetus
need for neonatal resuscitation
Measured: immediately after delivery of the fetus
need for NICU admission
Measured: immediately after delivery of the fetus
Neonatal respiratory distress .
Measured: immediately after delivery of the fetus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2019
- Primary completion10 Mar 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Model description
- Cases were divided into 2 groups: Group I (paracetamol group): Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor \[roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%\]. Group 2 (pethidine group): Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor \[roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%\]. Randomization was done by a computer-generated randomization system. Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsibai Anter, Menoufia University
- Investigators
- Mohamed Anter, Study director, Faculty of medicine-Menoufia university-shebin elkom -egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744727
- Sponsor's protocol ID
- 11/2019OBSGN/27
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anter ME, Abdel Attey Saleh S, Shawkey Allam S, Mohamed Nofal A. Efficacy and safety of intravenous paracetamol in management of labour pains in a low resource setting: a randomized clinical trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6320-6328. doi: 10.1080/14767058.2021.1911995. Epub 2021 Apr 26.
PubMed 33902372
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intravenous Paracetamol in Manament of Labour Pain in a Low Resource Setting
- ClinicalTrials.gov ID
- NCT04744727
- Acronym / sponsor ID
- 11/2019OBSGN/27
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 9 Feb 2021 (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.
to compare between the use of single dose of paracetamol and pethidine hydrochloride intravenously in management of labour pains
Detailed description
investigators conducted a randomized clinical study included including 96 primiparous women admitted to Obstetrics and Gynecology Department, Menoufia University Hospitals, starting the study from May 2019 to March 2020 to assess the use of paracetamol intravenously versus Pethidine HCL intravenously in management of intrapartum pain. After obtaining approval from the local ethics committee, women who agreed to participate gave their signed informed consent after explanation of the trial benefits and hazards
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cases were divided into 2 groups: Group I (paracetamol group): Included 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. Group 2 (pethidine group): Included 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. Randomization was done by a computer-generated randomization system. Letters of the allocated were concealed in serially numbered opaque envelope that were only released after recruitment.
| Arm | Type | Receives |
|---|---|---|
| paracetamol group | Active comparator | Drug: paracetamol-pethidineIncluded 48 pregnant women who received 1000 mg of intravenous paracetamol. The treatment was administered at the begining of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. |
| pethidine group | Active comparator | Drug: paracetamol-pethidineIncluded 48 pregnant women who received 50 mg of intravenous pethidine HCL diluted in 10 ml normal saline. The treatment was administered at the beginning of the active phase of 1st stage of labor [roughly defined as a cervical dilatation of 3-4 cm and a cervical effacement ≥ 50%]. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Primiparous
- aged 18-35 years,
- Term live singleton pregnancy,
- Vertex presentation,
- Spontaneous onset of labor at term 37-42 weeks gestation,
Key exclusion criteria (10 listed)
- Clinical evidence of cephalopelvic disproportion
- Use of any kind of analgesia prior to study
- Any medical disorder during pregnancy (liver or kidney impairment)
- Induction of labor, Intrauterine fetal death
- Evidence of fetal distress
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 |
|---|---|---|
| paracetamol-pethidine100 ml containing 1000 mg paracetamol -50 mg pethidine HCL | Drug | paracetamol group, pethidine group |
Primary outcome
change of the intensity of perceived labor pain.
Time frame: immediately after the intervention and up to 3 hours after the intervension
Labour pain was semi-objectively assessed using the visual analogue scale (VAS). In this technique, the patient is shown a ten cm line which represent at one end no pain and the other worst pain, and the patient is asked to point on the line where her pain lies. This scale has the added advantage that the pain can be given a numerical value.
9 secondary outcomes
duration of the active phase of the 1st stage of labor
Time frame: immediately from start of active phase of the 1st stage of labor till the end of first stage
duration of the 2nd stage of labor
Time frame: immediately from start of second stage till deliver of fetus
need for further analgesia
Time frame: immediately after the intervention till the end of first stage of labour
maternal dizziness, nausea and/or vomiting
Time frame: immediately after the intervention till the end of first stage
mode of delivery (vaginal or by caesarian
Time frame: immediately after the intervention
1- and 5-minutes Apgar scores.
Time frame: immediately after delivery of the fetus
need for neonatal resuscitation
Time frame: immediately after delivery of the fetus
need for NICU admission
Time frame: immediately after delivery of the fetus
Neonatal respiratory distress .
Time frame: immediately after delivery of the fetus
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 9 Feb 2021.
- Derived from this study: PubMed 33902372Anter ME, Abdel Attey Saleh S, Shawkey Allam S, Mohamed Nofal A. Efficacy and safety of intravenous paracetamol in management of labour pains in a low resource setting: a randomized clinical trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6320-6328. doi: 10.1080/14767058.2021.1911995. Epub 2021 Apr 26.
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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.
Mohamed Anter study director
Faculty of medicine-Menoufia university-shebin elkom -egypt
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-pethidine in people with Labor Pain, run by Menoufia University at 1 site in Egypt.
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 6 inclusion and 10 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 9 Feb 2021. 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 Egypt. 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?
change of the intensity of perceived labor pain. (time frame: immediately after the intervention and up to 3 hours after the intervension). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04744727, which also lists 1 linked publication.
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 9 Feb 2021.