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

NCT03510130 | Unknown

• 1 other identifier: 0553-17-RMB
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Delivery Affecting Fetus or Newborn

Outcome Measures

Primary Outcomes (1)

• 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)

  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)

  up to 12 months

Study Arms (2)

Routine leg movement

EXPERIMENTAL

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

Other: Routine leg movement

Control group

NO INTERVENTION

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

Interventions

Routine leg movement 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.

Routine leg movement

Eligibility Criteria

• Age: 15 Years - 50 Years
• Gender Eligibility Details: Obstetrical study
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: April 27, 2018
• Study Start: May 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share