Passive Descent in Obese Nulliparous Gravidae

Can Passive Descent Increase the Spontaneous Vaginal Delivery Rate in Obese Women?

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.

Study Overview

• Status: Unknown
• Conditions: Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.
• Intervention / Treatment: Procedure: Pushing; Procedure: Passive Descent

• Study Type: Interventional
• Enrollment (Anticipated): 540
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women and Infants Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate Pushing; Patient's will begin to push when they are determined to be completely dilated.	Procedure: Pushing
Experimental: Passive Descent; Patient's will wait 90 minutes prior to begin pushing	Procedure: Passive Descent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of spontaneous vaginal delivery	At delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of infections (defined as fever and / or antibiotic initiation)		participants will be followed for the duration of hospital stay, an expected average of 3 days
Rate of Third and Fourth Degree Lacerations		At delivery
Rate of Postpartum Hemorrhage		At delivery
Neonatal Outcomes	admission to NICU; umbilical cord pH <7.1	At delivery

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island
• Investigators: Principal Investigator: Alisse Hauspurg, MD, Women & Infant's Hospital; Study Director: Erika Werner, MD, Women & Infant's Hospital

Study record dates

Study Major Dates

• Primary Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: March 3, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Estimate): March 6, 2014
• Last Update Submitted That Met QC Criteria: March 5, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: WIHRI-PD