Ignite Creation Date:
2024-07-17 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488781
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-28
Brief Title:
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 20
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 20 APPOINT 20 A Multi-center Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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
Detailed Description:
This is a multi-center randomized placebo-controlled trial in which nulliparous women with obesity who are undergoing induction of labor at term and not receiving IAP for GBS will be recruited n787 The participants will be randomized 11 to receive either prophylactic antibiotics during their labor induction azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses or like-appearing placebos The participants and their obstetrical providers will be blinded to the study intervention The study will be conducted with an identical protocol at five study sites Trained research nursesassistants at each study site will consent and enroll participants collect biospecimens and collect demographic information and data on pregnancy and neonatal outcomes and will convey this data to the primary site for analysis
Researchers hypothesize that the group that receives the study drug regimen of prophylactic antibiotics during induction of labor will have a lower rate of cesarean delivery than the group that receives the placebo They also hypothesize that the group that receives the study drug regimen will have a lower rate of puerperal infection than the placebo group
Nulliparous women with obesity who are undergoing induction of labor at term will be eligible for participation in the study Across all sites 787 total subjects will be recruited
Researchers hypothesize that the group that receives the study drug regimen of prophylactic antibiotics during induction of labor will have a lower rate of cesarean delivery than the group that receives the placebo They also hypothesize that the group that receives the study drug regimen will have a lower rate of puerperal infection than the placebo group
Nulliparous women with obesity who are undergoing induction of labor at term will be eligible for participation in the study Across all sites 787 total subjects will be recruited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None