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

Rambam Health Care Campus

Status: Unknown

Conditions: Cesarean Delivery Affecting Fetus or Newborn

Treatments: Other: Routine leg movement

Study type: Interventional

Funder types: Other

Identifiers

NCT03510130

0553-17-RMB

Details and patient eligibility

About

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.

Full description

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 )

Enrollment: 300 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Routine leg movement

Experimental group

Description:

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

Treatment:

Other: Routine leg movement

Control group

No Intervention group

Description:

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