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

Primary Purpose

Labor Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Routine pain management
No inquiry regarding analgesia
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Labor Pain

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Rambam health care campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Labor+routine pain management

Labor+experimental pain management

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Analgesia during labor
Which modalities of analgesia the participant took during labor
Cervical dilatation at the time of epidural anesthesia
Cervical dilatation at the time of choice to receive epidural anesthesia.

Full Information

First Posted
February 5, 2017
Last Updated
September 12, 2020
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT03045705
Brief Title
Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
Official Title
Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Problem with patient recruitment
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Labor+routine pain management
Arm Type
Active Comparator
Arm Description
Women that will be treated by the medical team in the delivery room as if not part of a study regarding pain management.
Arm Title
Labor+experimental pain management
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Routine pain management
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No inquiry regarding analgesia
Intervention Description
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 Measure Information:
Title
Visual analogue scale at the time of epidural anesthesia
Description
Visual analogue scale as reflected by the participant at the time of choice to receive epidural anesthesia.
Time Frame
Up to 3 days from admission.
Secondary Outcome Measure Information:
Title
Visual analogue scale at the time of first medical analgesia
Description
Visual analogue scale as reflected by the participant at the time of choice to receive the first modality of analgesia.
Time Frame
Up to 3 days from admission.
Title
Analgesia during labor
Description
Which modalities of analgesia the participant took during labor
Time Frame
Up to 3 days from admission.
Title
Cervical dilatation at the time of epidural anesthesia
Description
Cervical dilatation at the time of choice to receive epidural anesthesia.
Time Frame
Up to 3 days from admission.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Lauterbach, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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