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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03045705
Enrollment
0
Registered
2017-02-07
Start date
2019-03-01
Completion date
2020-09-01
Last updated
2020-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

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.

Interventions

BEHAVIORALRoutine 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.

BEHAVIORALNo 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.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual analogue scale at the time of epidural anesthesiaUp to 3 days from admission.Visual analogue scale as reflected by the participant at the time of choice to receive epidural anesthesia.

Secondary

MeasureTime frameDescription
Visual analogue scale at the time of first medical analgesiaUp 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 laborUp to 3 days from admission.Which modalities of analgesia the participant took during labor
Cervical dilatation at the time of epidural anesthesiaUp to 3 days from admission.Cervical dilatation at the time of choice to receive epidural anesthesia.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026