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

September 12, 2020 updated by: ROY LAUTERBACH MD, Rambam Health Care Campus
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.

Study Overview

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Haifa, Israel
        • Rambam Health Care Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 5, 2017

First Posted (Estimate)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 12, 2020

Last Verified

September 1, 2020

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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