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Passive Descent in Obese Nulliparous Gravidae

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02080429
Enrollment
540
Registered
2014-03-06
Start date
Unknown
Completion date
Unknown
Last updated
2014-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of the Second Stage of Labor in Obese Nulliparous Women by Either Passive Descent or Immediate Pushing.

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.

Interventions

PROCEDUREPassive Descent
PROCEDUREPushing

Sponsors

Women and Infants Hospital of Rhode Island
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE

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)

Design outcomes

Primary

MeasureTime frame
Rate of spontaneous vaginal deliveryAt delivery

Secondary

MeasureTime frameDescription
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 LacerationsAt delivery
Rate of Postpartum HemorrhageAt delivery
Neonatal OutcomesAt delivery* admission to NICU * umbilical cord pH \<7.1

Countries

United States

Contacts

Primary ContactAlisse Hauspurg, MD
ahauspurg@wihri.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026