Cesarean Delivery Affecting Fetus or Newborn Clinical Trial
Official title:
Routine Maternal Leg Movements During the Second Stage and the Rate of Operative Deliveries
| Verified date | May 2018 |
| Source | Rambam Health Care Campus |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 300 |
| Est. completion date | March 2019 |
| Est. primary completion date | January 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 15 Years to 50 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Rambam Health Care Campus |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |