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

Not Applicable
Withdrawn
Conditions
Labor Pain
Interventions
Behavioral: Routine pain management
Behavioral: No inquiry regarding analgesia
Registration Number
NCT03045705
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
Female
Target Recruitment
Not specified
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Labor+routine pain managementRoutine 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 managementNo 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.
Primary Outcome Measures
NameTimeMethod
Visual analogue scale at the time of epidural anesthesiaUp 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
NameTimeMethod
Analgesia during laborUp to 3 days from admission.

Which modalities of analgesia the participant took during labor

Cervical dilatation at the time of epidural anesthesiaUp to 3 days from admission.

Cervical dilatation at the time of choice to receive epidural anesthesia.

Visual analogue scale at the time of first medical analgesiaUp 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.

Trial Locations

Locations (1)

Rambam health care campus

🇮🇱

Haifa, Israel

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