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

Rambam Health Care Campus

Status: Withdrawn

Conditions: Labor Pain

Treatments: Behavioral: Routine pain management; Behavioral: No inquiry regarding analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03045705

0071-17-RMB

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Labor+routine pain management

Active Comparator group

Description:

Women that will be treated by the medical team in the delivery room as if not part of a study regarding pain management.

Treatment:

Behavioral: Routine pain management

Labor+experimental pain management

Active Comparator group

Description:

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.

Treatment:

Behavioral: No inquiry regarding analgesia