Clinical trial NCT03045705: Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
Official title: Evaluation of the Effect the Medical Team in the Delivery Room Has on Pain Management During Labor.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Labor Pain
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual analogue scale at the time of epidural anesthesia
timeFrame: Up to 3 days from admission.
Secondary outcomes:
measure: Visual analogue scale at the time of first medical analgesia
timeFrame: Up to 3 days from admission.
measure: Analgesia during labor
timeFrame: Up to 3 days from admission.
measure: Cervical dilatation at the time of epidural anesthesia
timeFrame: Up to 3 days from admission.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References: