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

Not Applicable

• Conditions: Cesarean Delivery Affecting Fetus or Newborn
• Interventions: Other: Routine leg movement

• Registration Number: NCT03510130
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

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 )

Study Timeline

• Study First Submitted: 2018-03-11
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-27
• Status Verified: 2018-05
• Study Start: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-04
• Primary Completion: 2019-01
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine leg movement	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.

Primary Outcome Measures

Name	Time	Method
Routine legs movement during the second stage of labor and the rates of cesarean deliveries (In percentage of the total deliveries) and instrumental deliveries (In percentage of total deliveries)	up to 12 months	The study objective is to determine whether routine maternal leg movement during the second stage of labor decreases the rate of operative deliveries (instrumental and cesarean deliveries)