Passive Descent in Obese Nulliparous Gravidae
Primary Purpose
Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Passive Descent
Pushing
Sponsored by

About this trial
This is an interventional treatment trial for Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.
Eligibility Criteria
Inclusion Criteria:
- Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)] greater than or equal to 30 as determined at the time of admission to labor and delivery
- Regional anesthesia
- Nulliparous (defined as no deliveries after 20 weeks gestation)
- Gestational age of 37 0/7 weeks and greater
- Singleton Pregnancy
Exclusion Criteria:
- Body mass index (BMI) calculated as weight (kg)/ [height (m2)] less than 30 as determined at the time of admission to labor and delivery
- No regional anesthesia
- Multiparous
- Gestational age of less than 37 0/7 weeks
- Multiple gestations
- Maternal fever prior to second stage
- Severe fetal anomalies (incompatible with life)
Sites / Locations
- Women and Infants Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Immediate Pushing
Passive Descent
Arm Description
Patient's will begin to push when they are determined to be completely dilated.
Patient's will wait 90 minutes prior to begin pushing
Outcomes
Primary Outcome Measures
Rate of spontaneous vaginal delivery
Secondary Outcome Measures
Rate of infections (defined as fever and / or antibiotic initiation)
Rate of Third and Fourth Degree Lacerations
Rate of Postpartum Hemorrhage
Neonatal Outcomes
admission to NICU
umbilical cord pH <7.1
Full Information
NCT ID
NCT02080429
First Posted
March 3, 2014
Last Updated
March 5, 2014
Sponsor
Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT02080429
Brief Title
Passive Descent in Obese Nulliparous Gravidae
Official Title
Can Passive Descent Increase the Spontaneous Vaginal Delivery Rate in Obese Women?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Obesity rates in reproductive aged women in the United States are rising. It is now universally accepted that obesity is associated with many adverse pregnancy outcomes and post-operative complications following cesarean section. Recent studies have also shown an increased rate of cesarean section in obese women, adding to the already elevated rate of complications and adverse outcomes. Given the increased a priori risk for obese patients, it is vital that the investigators reexamine management practices routinely used for normal weight women in this specific high-risk population. Passive descent has been shown to increase the spontaneous vaginal delivery rate in non-obese women; however, high quality studies have never been performed in obese women. the investigators hypothesize that passive descent could improve the spontaneous vaginal delivery rate in nulliparous, obese women with regional anesthesia. This study will randomize women to passive descent for ninety minutes or active pushing upon entry into the second stage. Further, given that passive descent is widely accepted in the midwifery literature and clinical practice, the investigators anticipate that a high-quality study in the physician literature could increase the dialogue between practitioners and lead to development of best practices in this high-risk population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
540 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Pushing
Arm Type
Active Comparator
Arm Description
Patient's will begin to push when they are determined to be completely dilated.
Arm Title
Passive Descent
Arm Type
Experimental
Arm Description
Patient's will wait 90 minutes prior to begin pushing
Intervention Type
Procedure
Intervention Name(s)
Passive Descent
Intervention Type
Procedure
Intervention Name(s)
Pushing
Primary Outcome Measure Information:
Title
Rate of spontaneous vaginal delivery
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Rate of infections (defined as fever and / or antibiotic initiation)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 3 days
Title
Rate of Third and Fourth Degree Lacerations
Time Frame
At delivery
Title
Rate of Postpartum Hemorrhage
Time Frame
At delivery
Title
Neonatal Outcomes
Description
admission to NICU
umbilical cord pH <7.1
Time Frame
At delivery
10. Eligibility
Sex
Female
Eligibility Criteria
Inclusion Criteria:
Obese - body mass index (BMI) calculated as weight (kg)/ [height (m2)] greater than or equal to 30 as determined at the time of admission to labor and delivery
Regional anesthesia
Nulliparous (defined as no deliveries after 20 weeks gestation)
Gestational age of 37 0/7 weeks and greater
Singleton Pregnancy
Exclusion Criteria:
Body mass index (BMI) calculated as weight (kg)/ [height (m2)] less than 30 as determined at the time of admission to labor and delivery
No regional anesthesia
Multiparous
Gestational age of less than 37 0/7 weeks
Multiple gestations
Maternal fever prior to second stage
Severe fetal anomalies (incompatible with life)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alisse Hauspurg, MD
Email
ahauspurg@wihri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alisse Hauspurg, MD
Organizational Affiliation
Women & Infant's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erika Werner, MD
Organizational Affiliation
Women & Infant's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
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Passive Descent in Obese Nulliparous Gravidae
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