Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04616170 |
| Other study ID # |
2020P003603 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 5, 2021 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
March 2022 |
| Source |
Massachusetts General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It is common practice for practitioners to instruct patients to forcibly flex the hips at the
time of delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume
that this forced stretching of the perineum at the time of fetal vertex emergence could
potentially lead to higher rates of severe lacerations and their sequelae. This study will
examine whether extending the hips, as compared to usual care, at the time of crowning of the
fetal vertex during vaginal delivery decreases maternal perineal trauma among nulliparous
women.
Description:
Perineal trauma at the time of vaginal delivery is a significant cause of maternal morbidity
including vaginal pain, dyspareunia, urinary incontinence, infection, and social isolation in
severe cases. There are well known risk factors in the literature for OASIS (obstetric anal
sphincter injuries), however, this literature is by no means comprehensive. A prior RCT in
2012 looked at the role of patient positioning at the time of pushing and delivery to
determine whether stirrup positioning and forced hip flexion leads to higher rates of any
perineal tears. The study concluded that stirrup positioning did not lead to higher rates of
perineal tearing but was not powered to evaluate the role of positioning on OASIS tears or on
postpartum perineal morbidity.
In addition to lacking data with respect to patient positioning, data is limited regarding
perineal morbidity beyond the traditional grading system of 1st, 2nd, 3rd, and 4th degree
tears. 3rd and 4th degree lacerations are labeled as OASIS, however, perineal morbidity can
result from "lower" orders of perineal tearing at the time of delivery. Prior studies have
tried to illustrate various subsets of second degree lacerations in an attempt to subdivide
2nd degree lacerations into categories of severity, however, little has been done in practice
with this form of division and little is written on the topic of perineal morbidity beyond
OASIS tears.
It is common practice for practitioners to instruct patients to flex the hips at the time of
delivery of the fetal vertex. Though this is commonplace, it is reasonable to assume that
this stretching of the perineum at the time of fetal vertex emergence could potentially lead
to higher rates of severe lacerations and their sequelae. The closest studies to examine this
have been in comparing women who deliver in the squatting position compared to in lithotomy.
Those who deliver in squatting positions have been found to have deeper perineal lacerations,
which demonstrate the possibility that forced flexion at the hips could lead to the same
outcome in the lithotomy position. Should research show an increased risk of morbidity with
this near universal positioning practice as compared to hip extension, this study could
change practice patterns for the betterment of patients worldwide.
