Routine Maternal Leg Movements During the Second Stage and the Rate of Operative Deliveries

NCT ID: NCT03510130

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2019-03-31

Brief Summary

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Cesarean delivery rates have risen in the US in a dramatic fashion from less than 5% in the 1960 to 32.7% by 2013 with stable rate around 32-33% in the last five years , cesarean delivery is associated with increased maternal morbidity and mortality, Labor arrest is the most common indication for cesarean delivery, Maternal position during the second stage of labor has been suggested to affect the risk of instrumental vaginal delivery. A Cochrane review of position in the second stage of labor in women without epidural showed a reduction in instrumental vaginal delivery in the upright group, although the quality of the included trials was reported to be generally poor, A Cochrane review of position in the second stage of labour for women with epidural analgesia was published in 2017, This review included trials that compared upright with recumbent positions and suggested no effect.

No prior studies examined whether maternal legs movement during the second stage of labor has any effect on the rate of operative deliveries.

Detailed Description

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A randomized controlled trial to determine whether routine maternal leg movement during the second stage of labor decreases the rate of operative deliveries (instrumental delivery of cesarean section )

Conditions

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Cesarean Delivery Affecting Fetus or Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Routine leg movement

Intervention group- In the second stage of labor, attending physician or nurse will help the participant in routine leg movements every 20-30 minutes.

Group Type EXPERIMENTAL

Routine leg movement

Intervention Type OTHER

Routine leg movement to the right and left in the supine position during the second stage of labor, for 3 minutes every 20-30 minutes by the attending physician or nurse.

Control group

Control group which includes women during the second stage of labor with no intervention (routine leg movement).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Routine leg movement

Routine leg movement to the right and left in the supine position during the second stage of labor, for 3 minutes every 20-30 minutes by the attending physician or nurse.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

•Women who had a low risk pregnancy followed by an uncomplicated vaginal delivery, instrumental delivery or cesarean section.

Exclusion Criteria

•Women who had a high risk pregnancy ((IUGR, hypertension disorders of pregnancy, maternal cardiovascular or respiratory illness).
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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0553-17-RMB

Identifier Type: -

Identifier Source: org_study_id

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