Clinical trial NCT02080429: Passive Descent in Obese Nulliparous Gravidae
Official title: Can Passive Descent Increase the Spontaneous Vaginal Delivery Rate in Obese Women?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 540
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Rate of spontaneous vaginal delivery
timeFrame: At delivery
Secondary outcomes:
measure: Rate of infections (defined as fever and / or antibiotic initiation)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: Rate of Third and Fourth Degree Lacerations
timeFrame: At delivery
measure: Rate of Postpartum Hemorrhage
timeFrame: At delivery
measure: Neonatal Outcomes
timeFrame: At delivery
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital
state: Rhode Island
Study officials:
affiliation: Women & Infant's Hospital
name: Alisse Hauspurg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women & Infant's Hospital
name: Erika Werner, MD
role: STUDY_DIRECTOR
References: