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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03045705
Other study ID # 0071-17-RMB
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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.
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