4P: The Patient Positioning for Perineal Protection Study

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04616170

Collaborator

(none)

1,206

Enrollment

Location

Arms

35.9

Anticipated Duration (Months)

33.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Perineal Tear Delivery; Trauma Perineal Laceration	Other: Hip extension Other: Usual Care	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients will be assigned to usual care or hip extension at the time of delivery of the fetal vertexPatients will be assigned to usual care or hip extension at the time of delivery of the fetal vertex

Masking:

Single (Outcomes Assessor)

Masking Description:

The statistician performing the primary analysis will be blinded to the assignment of the patients

Primary Purpose:

Prevention

Official Title:

The Patient Positioning for Perineal Protection Study

Actual Study Start Date :

Apr 5, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Usual care Patients in this arm will be randomized to the routine positioning instructions given at the time of crowning of the fetal vertex during vaginal delivery.	Other: Usual Care Hips positioned in the "usual care" position per provider preference at the time of vaginal delivery
Experimental: Hip extension Patients in this arm will be randomized to hip extension at the time of crowning of the fetal vertex during vaginal delivery.	Other: Hip extension Hips extended at the time of vaginal delivery

Arm

Intervention/Treatment

Active Comparator: Usual care

Patients in this arm will be randomized to the routine positioning instructions given at the time of crowning of the fetal vertex during vaginal delivery.

Other: Usual Care

Hips positioned in the "usual care" position per provider preference at the time of vaginal delivery

Experimental: Hip extension

Patients in this arm will be randomized to hip extension at the time of crowning of the fetal vertex during vaginal delivery.

Other: Hip extension

Hips extended at the time of vaginal delivery

Outcome Measures

Primary Outcome Measures

Classification of perineal laceration [At the time of vaginal delivery]
The degree of perineal laceration as classified by the American College of Obstetricians and Gynecologists (ACOG) classification system

Secondary Outcome Measures

Rate of OASIS laceration [At the time of vaginal delivery]
Number of obstetric anal sphincter injury lacerations compared to all deliveries

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Nulliparous women
Non-anomalous fetuses
Term gestation
Vertex presentation
Eligible for trial of labor

Exclusion Criteria:

Multiparous women
Prior perineal malformations
History female genital mutilation
Prior perineal surgery
Anomalous fetuses
Multiple gestations
Fetal status incompatible with labor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Study Director: Marti D Soffer, MD MPH, Massachusetts General Hospital
Principal Investigator: William H Barth, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

William H. Barth, Jr., MD, Vice Chair, Obstetrics (Chief of Obstetrics), Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT04616170

Other Study ID Numbers:

2020P003603

First Posted:

Nov 4, 2020

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by William H. Barth, Jr., MD, Vice Chair, Obstetrics (Chief of Obstetrics), Massachusetts General Hospital

Additional relevant MeSH terms:

Lacerations

Study Results

No Results Posted as of Mar 31, 2022