- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045705
Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel
- Rambam Health Care Campus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women planned for vaginal delivery.
Exclusion Criteria:
- Women planned for cesarean section.
- Women with comorbidities related to pain that may exacerbate during labor.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Labor+routine pain management
Women that will be treated by the medical team in the delivery room as if not part of a study regarding pain management.
|
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.
|
Active Comparator: Labor+experimental pain management
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 3 days from admission.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale at the time of first medical analgesia
Time Frame: Up to 3 days from admission.
|
Visual analogue scale as reflected by the participant at the time of choice to receive the first modality of analgesia.
|
Up to 3 days from admission.
|
Analgesia during labor
Time Frame: Up to 3 days from admission.
|
Which modalities of analgesia the participant took during labor
|
Up to 3 days from admission.
|
Cervical dilatation at the time of epidural anesthesia
Time Frame: Up to 3 days from admission.
|
Cervical dilatation at the time of choice to receive epidural anesthesia.
|
Up to 3 days from admission.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0071-17-RMB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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