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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age15-45
SponsorUniversity of Oklahoma

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

BMI ≥30

No prior deliveries at or beyond 20 weeks gestation

Undergoing induction of labor

Gestational age 37 weeks or more

Disqualifiers

Fetal death prior to labor induction

Known fetal anomaly

Multiple gestation

Ruptured membranes for more than 12 hours

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azithromycin

    Drug

    Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses

  • Placebo

    Drug

    Placebo given in place of other two active drugs

Treatment groups

787 Participants
are divided into 2 treatment groups
Group A: Prophylactic antibioticsActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of cesarean delivery

Determine whether a prophylactic antibiotic regimen during labor induction will decrease the rate of cesarean delivery in obese, nulliparous women undergoing induction of labor

Time frame
30 days postpartum

Secondary outcomes

1

Rate of chorioamnionitis development

Defined clinically by fever and maternal and fetal signs such as tachycardia and uterine tenderness

Time frame
30 days postpartum
2

Rate of endometritis

Maternal development of endometritis

Time frame
30 days postpartum
3

Rate of cesarean wound infection

Rate of maternal would infection from cesarean section

Time frame
30 days postpartum
4

Rate of postpartum hemorrhage

Rate of maternal postpartum hemorrhage

Time frame
30 days postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oklahoma

Lead sponsor

University of Alabama at Birmingham

Collaborator

University of Florida

Collaborator

Duke University

Collaborator

Case Western Reserve University

Collaborator

University of Utah

Collaborator