Labor PainNCT03045705
Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
A study testing Routine pain management and No inquiry regarding analgesia in people with Labor Pain, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
In the current study the investigators wish to evaluate the effect the doctors and midwives in the delivery room have on the timing and modality of analgesia chosen by the participants. The participants will be randomly divided into 2 groups. 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?
- Routine pain management and No inquiry regarding analgesia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to 1 Sep 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women planned for vaginal delivery.
Who cannot join
- Women planned for cesarean section.
- Women with comorbidities related to pain that may exacerbate during labor.
Trial locations and contacts
1 site in 1 country.
About this study
In the current study the investigators wish to evaluate the effect the doctors and midwives in the delivery room have on the timing and modality of analgesia chosen by the participants. The participants will be randomly divided into 2 groups. Both groups will be advised of the different modalities of analgesia available during labor. One group will be managed in the delivery room the same as if not part of the study, meaning the doctors and midwives will treat the participants the way they usually do regarding analgesia. The second group of participants will not be asked by the doctors and midwives about analgesia at all but will be able to receive analgesia by a modality of choice at the timing of choice.
Read the detailed description
After explaining to the participants the study and having signed a confirmed consent, participants will receive an extensive explanation regarding the different modalities of analgesia available during labor. After the explanations the participants will be randomly divided into 2 groups:
- Routine management-doctors and midwives will treat the participants the way they usually do regarding analgesia including frequent inquiries about wishes for analgesia.
- Interventional management-participants will not be asked by the doctors and midwives about analgesia at all during labor but will be able to receive analgesia by a modality of choice at the timing of choice after being advised by the medical team.
After delivery, participants will fill a questionnaire regarding the experience of labor in general and the relevance of analgesia during labor including the effect the medical team may have had on decision making during labor.
Medical information regarding visual analogue scale (VAS), analgesia modality, cervical conditions, parity etc. will be extracted from patients' electronic files.
- Conditions
- Labor Pain
- Being tested
- Routine pain management, No inquiry regarding analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine pain managementBehavioural
Women that will be asked according to the routine management regarding pain management during labor, meaning frequent inquiries regarding the woman's wishes to receive analgesia by the medical team.
No inquiry regarding analgesiaBehavioural
women will not be asked about analgesia during labor by the medical team, but will be able to receive the modality of choice at the time of choice.
| Study group | Role | What they receive |
|---|---|---|
| Labor+routine pain management | Active comparator | Women that will be treated by the medical team in the delivery room as if not part of a study regarding pain management. Receives: Behavioral: Routine pain management |
| Labor+experimental pain management | Active comparator | Women that will not be asked at all by the medical team in the delivery room regarding analgesia during labor but will be able to receive analgesia at wish at the time of choice. Receives: Behavioral: No inquiry regarding analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale at the time of epidural anesthesia
Visual analogue scale as reflected by the participant at the time of choice to receive epidural anesthesia.
Measured: Up to 3 days from admission.
Secondary outcomes (3)
Visual analogue scale at the time of first medical analgesia
Visual analogue scale as reflected by the participant at the time of choice to receive the first modality of analgesia.
Measured: Up to 3 days from admission.
Analgesia during labor
Which modalities of analgesia the participant took during labor
Measured: Up to 3 days from admission.
Cervical dilatation at the time of epidural anesthesia
Cervical dilatation at the time of choice to receive epidural anesthesia.
Measured: Up to 3 days from admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Mar 2019
- Primary completion31 Jul 2020
- Study completion1 Sep 2020
Why it stopped: Problem with patient recruitment
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROY LAUTERBACH MD, Rambam Health Care Campus
- Investigators
- Roy Lauterbach, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045705
- Sponsor's protocol ID
- 0071-17-RMB
- Status last verified
- Sep 2020
- First submitted
- 5 Feb 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- 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 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
- ClinicalTrials.gov ID
- NCT03045705
- Acronym / sponsor ID
- 0071-17-RMB
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problem with patient recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 7 Feb 2017 (estimated)
- 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.
In the current study the investigators wish to evaluate the effect the doctors and midwives in the delivery room have on the timing and modality of analgesia chosen by the participants. The participants will be randomly divided into 2 groups. Both groups will be advised of the different modalities of analgesia available during labor. One group will be managed in the delivery room the same as if not part of the study, meaning the doctors and midwives will treat the participants the way they usually do regarding analgesia. The second group of participants will not be asked by the doctors and midwives about analgesia at all but will be able to receive analgesia by a modality of choice at the timing of choice.
Detailed description
After explaining to the participants the study and having signed a confirmed consent, participants will receive an extensive explanation regarding the different modalities of analgesia available during labor. After the explanations the participants will be randomly divided into 2 groups:
- Routine management-doctors and midwives will treat the participants the way they usually do regarding analgesia including frequent inquiries about wishes for analgesia.
- Interventional management-participants will not be asked by the doctors and midwives about analgesia at all during labor but will be able to receive analgesia by a modality of choice at the timing of choice after being advised by the medical team.
After delivery, participants will fill a questionnaire regarding the experience of labor in general and the relevance of analgesia during labor including the effect the medical team may have had on decision making during labor.
Medical information regarding visual analogue scale (VAS), analgesia modality, cervical conditions, parity etc. will be extracted from patients' electronic files.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Labor+routine pain management | Active comparator | Behavioral: Routine pain managementWomen that will be treated by the medical team in the delivery room as if not part of a study regarding pain management. |
| Labor+experimental pain management | Active comparator | Behavioral: No inquiry regarding analgesiaWomen that will not be asked at all by the medical team in the delivery room regarding analgesia during labor but will be able to receive analgesia at wish at the time of choice. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women planned for vaginal delivery.
Key exclusion criteria (2 listed)
- Women planned for cesarean section.
- Women with comorbidities related to pain that may exacerbate during labor.
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 |
|---|---|---|
| Routine pain managementWomen that will be asked according to the routine management regarding pain management during labor, meaning frequent inquiries regarding the woman's wishes to receive analgesia by the medical team. | Behavioural | Labor+routine pain management |
| No inquiry regarding analgesiawomen will not be asked about analgesia during labor by the medical team, but will be able to receive the modality of choice at the time of choice. | Behavioural | Labor+experimental pain management |
Primary outcome
Visual analogue scale at the time of epidural anesthesia
Time frame: Up to 3 days from admission.
Visual analogue scale as reflected by the participant at the time of choice to receive epidural anesthesia.
3 secondary outcomes
Visual analogue scale at the time of first medical analgesia
Time frame: Up to 3 days from admission.
Analgesia during labor
Time frame: Up to 3 days from admission.
Cervical dilatation at the time of epidural anesthesia
Time frame: Up to 3 days from admission.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- 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.
Roy Lauterbach, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine pain management and No inquiry regarding analgesia in people with Labor Pain, run by Rambam Health Care Campus 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 2 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: withdrawn, as of the sponsor's last update on 16 Sep 2020. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Visual analogue scale at the time of epidural anesthesia (time frame: Up to 3 days from admission.). 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 16 Sep 2020.