Purpose of this Study
This study places pregnant women into one of two groups by chance. One group receives antibiotics when labor is started, including cefazolin through a vein and a one time dose of azithromycin. The other group receives placebo treatments that look the same but do not contain medicine.
After delivery, researchers will follow up with participants during their postpartum visit or by phone or email to collect information about their health and recovery. The goal is to learn whether giving these antibiotics during labor can improve outcomes for mothers and babies.
Who Can Participate?
Eligibility
People can join this study if they are pregnant, between 15 and 45 years old, and are having their first full term baby. They must have obesity, with a body mass index greater than 30, and be planning to have labor started with medicine. They cannot have a medical reason to receive antibiotics for Group B Streptococcus, also called GBS. Researchers are studying whether giving antibiotics during labor can help lower the chance of Cesarean delivery or infection after childbirth.
Age Range
15-45
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
Description
This study is testing whether giving antibiotics during labor can help lower the chance of needing a Cesarean section or getting an infection after childbirth. The study includes women who are having their first baby, have obesity, and need medicine to start labor.
Participants will be placed into one of two groups by chance. One group will receive antibiotics when labor is started, and the other group will receive a placebo, which has no active medicine. Researchers will compare the two groups to see if antibiotics improve outcomes for mothers and reduce problems after delivery.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
Principal Investigator
Brenna
Hughes
Protocol Number
PRO00116883
Phase
II
Enrollment Status
Open to Enrollment