RECRUITING

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Obesity increases the risk of pregnancy complications, including puerperal infections and cesarean delivery, and risk rises with increasing body mass index (BMI). Since obese women are more likely to have comorbidities that would necessitate delivery prior to their due date (i.e. prior to 40 weeks gestation), and class III obesity specifically is an indication for delivery by 39 weeks, these patients have a high rate of labor induction. In nulliparous women from the general population (obese and non-obese), labor induction at 39 weeks (compared to expectant management) is associated with less maternal morbidity and a lower cesarean rate. Researchers previously conducted a pilot randomized placebo-controlled trial in obese, nulliparous women undergoing labor induction at term and found that the cesarean delivery rate was lower in women who received a prophylactic antibiotic regimen during labor compared with those who received the placebo. Researchers proposed multi-center trial aims to test this hypothesis in a large sample with adequate power to determine whether prophylactic antibiotics during labor are associated with a decrease in the rate of cesarean delivery in term, nulliparous, obese women. If the findings from the pilot trial are confirmed, this would represent a novel intervention to decrease the cesarean delivery rate in a subset of women at highest risk for cesarean-related complications.

Official Title

Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0 (APPOINT 2.0): A Multi-center Randomized Controlled Trial

Quick Facts

Study Start:2024-07-26
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06488781

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * BMI ≥30
  2. * No prior deliveries at or beyond 20 weeks gestation
  3. * Undergoing induction of labor
  4. * Gestational age 37 weeks or more
  5. * Age 15-45
  6. * Not receiving IAP for GBS prophylaxis
  1. * Fetal death prior to labor induction
  2. * Known fetal anomaly
  3. * Multiple gestation
  4. * Ruptured membranes for more than 12 hours
  5. * Chorioamnionitis or other infection requiring antibiotics at the start of the labor induction
  6. * Previous myometrial surgery
  7. * Allergy to azithromycin or beta-lactam antibiotics

Contacts and Locations

Study Contact

Stephanie Pierce, MD
CONTACT
405-271-8787
stephanie-pierce@ouhsc.edu
Christy Zornes, MHR
CONTACT
405-271-8001
christy-zornes@ouhsc.edu

Principal Investigator

Stephanie Pierce, MD
PRINCIPAL_INVESTIGATOR
University of Oklahoma

Study Locations (Sites)

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Stephanie Pierce, MD, PRINCIPAL_INVESTIGATOR, University of Oklahoma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-07-26
Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity in Pregnancy
  • Labor Complication