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

NCT03045705 | Withdrawn

• 1 other identifier: 0071-17-RMB
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 3 days from admission.

Secondary Outcomes (3)

• Visual analogue scale at the time of first medical analgesia

  Up to 3 days from admission.

• Analgesia during labor

  Up to 3 days from admission.

• Cervical dilatation at the time of epidural anesthesia

  Up to 3 days from admission.

Study Arms (2)

Labor+routine pain management

ACTIVE COMPARATOR

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

Labor+experimental pain management

ACTIVE COMPARATOR

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

Interventions

Routine pain management BEHAVIORAL

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.

Labor+routine pain management

No inquiry regarding analgesia BEHAVIORAL

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.

Labor+experimental pain management

Eligibility Criteria

• Age: 18 Years - 44 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women planned for vaginal delivery.

You may not qualify if:

• Women planned for cesarean section.
• Women with comorbidities related to pain that may exacerbate during labor.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roy Lauterbach, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 7, 2017
• Study Start: March 1, 2019
• Primary Completion: July 31, 2020
• Study Completion: September 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)