Labor PainNCT05097950
Labor Induction and Pain Relief With Paracetamol Versus Placebo
A study testing Administration of 1 gr paracetamol I.V in people with Labor Pain, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Administration of 1 gr paracetamol I.V
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Sep 2021to 16 Jan 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter Nulliparity
Who cannot join
- Sensitivity to paracetamol.
- Past Cesarean section
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter
Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. An assessment of pain management will be conducted using various assessment tools. additionally, mode of delivery and time from catheter insertion to delivery will be assessed.
Read the detailed description
Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter.
assessment of pain during catheter balloon insertion will be assessed using visual analogue scale (VAS) instrument with scores 1 to 10.
An assessment of pain management will also be conducted using various assessment tools:
- Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals.
- Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter.
- Patient Experience Questionnaire - upon transfer to delivery room.
- Socio-demographic Questionnaire
Additionally, obstetrics outcomes will be recorded including time from catheter to delivery, mode of delivery. these parameters will be compared between the two groups (those who recieved paracetamol versus normal saline 0.9%).
- Conditions
- Labor Pain
- Being tested
- Administration of 1 gr paracetamol I.V
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of 1 gr paracetamol I.VDrug
Administration of 1 gr paracetamol I.V
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Administration of 1 gr paracetamol I.V Receives: Drug: Administration of 1 gr paracetamol I.V |
| Control Group | Placebo comparator | Administration of 100 ml. sodium chloride 0.9% IV Receives: Drug: Administration of 1 gr paracetamol I.V |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN assessment during catheter balloon insertion
pain assessment during catheter balloon insertion will be conducted using Visual Analogue Scale (VAS) instruments with scores from 10 to 10
Measured: through study completion, an average of 1 year
maternal satisfaction
maternal satisfaction will be evaluated using a questionnaire
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
need for additional analgesic agent
need for additional analgesic agent than paracetamol after catheter balloon insertion
Measured: through study completion, an average of 1 year
maternal mobility
women were asked through a questionnaire about whether they were immoblile after the catheter insetion using a score from 0 to 10
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start2 Sep 2021
- Primary completion9 Jan 2023
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Inshirah Sgayer, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097950
- Sponsor's protocol ID
- 0065-21-NHR
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2021
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Labor Induction and Pain Relief Prior to Insertion of a Balloon Catheter
- ClinicalTrials.gov ID
- NCT05097950
- Acronym / sponsor ID
- 0065-21-NHR
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 28 Oct 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.
Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter. An assessment of pain management will be conducted using various assessment tools. additionally, mode of delivery and time from catheter insertion to delivery will be assessed.
Detailed description
Single-blind study conducted on 2 randomly selected groups of pregnant women carrying a single fetus (from week 37 onward). One group will receive paracetamol 1 gr I.V. prior to insertion of balloon catheter and the control group will receive 100 ml sodium chloride 0.9% I.V prior to insertion of balloon catheter.
assessment of pain during catheter balloon insertion will be assessed using visual analogue scale (VAS) instrument with scores 1 to 10.
An assessment of pain management will also be conducted using various assessment tools:
- Brief Pain Inventory short form (BPIsf) - before balloon insertion and at various time intervals.
- Hospital Anxiety and Depression Scale (HADS) - 1 hr. before balloon insertion and immediately upon removal of catheter.
- Patient Experience Questionnaire - upon transfer to delivery room.
- Socio-demographic Questionnaire
Additionally, obstetrics outcomes will be recorded including time from catheter to delivery, mode of delivery. these parameters will be compared between the two groups (those who recieved paracetamol versus normal saline 0.9%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Drug: Administration of 1 gr paracetamol I.VAdministration of 1 gr paracetamol I.V |
| Control Group | Placebo comparator | Drug: Administration of 1 gr paracetamol I.VAdministration of 100 ml. sodium chloride 0.9% IV |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women from 18-44 yrs of age 37 weeks pregnant and onward singleton pregnancy induction of labor using a balloon catheter Nulliparity
Key exclusion criteria (3 listed)
- Sensitivity to paracetamol.
- Past Cesarean section
- Multiple pregnancy
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 |
|---|---|---|
| Administration of 1 gr paracetamol I.VAdministration of 1 gr paracetamol I.V | Drug | Control Group, Intervention Group |
Primary outcome
PAIN assessment during catheter balloon insertion
Time frame: through study completion, an average of 1 year
pain assessment during catheter balloon insertion will be conducted using Visual Analogue Scale (VAS) instruments with scores from 10 to 10
maternal satisfaction
Time frame: through study completion, an average of 1 year
maternal satisfaction will be evaluated using a questionnaire
2 secondary outcomes
need for additional analgesic agent
Time frame: through study completion, an average of 1 year
maternal mobility
Time frame: through study completion, an average of 1 year
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 Jan 2025.
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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 Administration of 1 gr paracetamol I.V in people with Labor Pain, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 3 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 Jan 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 Israel. 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. Some participants in this study may receive a placebo. 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?
PAIN assessment during catheter balloon insertion (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 9 Jan 2025.