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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03045705
• Other study ID #: 0071-17-RMB
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2020
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 3 days from admission.
Secondary	Analgesia during labor	Which modalities of analgesia the participant took during labor	Up to 3 days from admission.
Secondary	Cervical dilatation at the time of epidural anesthesia	Cervical dilatation at the time of choice to receive epidural anesthesia.	Up to 3 days from admission.