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Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045705
Recruitment Status : Withdrawn (Problem with patient recruitment)
First Posted : February 7, 2017
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Labor Pain Behavioral: Routine pain management Behavioral: No inquiry regarding analgesia Not Applicable

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:

  1. Routine management-doctors and midwives will treat the participants the way they usually do regarding analgesia including frequent inquiries about wishes for analgesia.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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.
Behavioral: Routine 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.
Behavioral: No inquiry regarding analgesia
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Analgesia during labor [ Time Frame: Up to 3 days from admission. ]
    Which modalities of analgesia the participant took during labor

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045705


Locations
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Israel
Rambam health care campus
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Roy Lauterbach, MD Rambam Health Care Campus
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Responsible Party: ROY LAUTERBACH MD, Primary investigator, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT03045705    
Other Study ID Numbers: 0071-17-RMB
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations