Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
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|ClinicalTrials.gov Identifier: NCT03045705|
Recruitment Status : Withdrawn (Problem with patient recruitment)
First Posted : February 7, 2017
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Labor Pain||Behavioral: Routine pain management Behavioral: No inquiry regarding analgesia||Not Applicable|
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:
- Routine management-doctors and midwives will treat the participants the way they usually do regarding analgesia including frequent inquiries about wishes for analgesia.
- 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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||July 31, 2020|
|Actual Study Completion Date :||September 1, 2020|
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.
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.
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.
Behavioral: 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.
- 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.
- 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.
- Analgesia during labor [ Time Frame: Up to 3 days from admission. ]Which modalities of analgesia the participant took during labor
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045705
|Rambam health care campus|
|Principal Investigator:||Roy Lauterbach, MD||Rambam Health Care Campus|