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Passive Descent in Obese Nulliparous Gravidae

NCT02080429 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2014-03-06

No results posted yet for this study

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.

Conditions

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

Interventions

PROCEDURE

Passive Descent

PROCEDURE

Pushing

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Alisse Hauspurg, MD · Women & Infant's Hospital

  • Erika Werner, MD · Women & Infant's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02080429 on ClinicalTrials.gov