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NCT Number: NCT06488781

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

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.

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Key information

Conditions

Obesity in Pregnancy Body Weight Female Urogenital Diseases and Pregnancy Complications Labor Complication Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obstetric Labor Complications Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy in Obesity Signs and Symptoms Urogenital Diseases

Age range

15 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location status: Recruiting

About this study

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 (n=787). The participants will be randomized 1:1 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 six study sites. Trained research nurses/assistants 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ≥30
  • No prior deliveries at or beyond 20 weeks gestation
  • Undergoing induction of labor
  • Gestational age 37 weeks or more
  • Age 15-45
  • Not receiving IAP for GBS prophylaxis

Exclusion criteria

  • Fetal death prior to labor induction
  • Known fetal anomaly
  • Multiple gestation
  • Ruptured membranes for more than 12 hours
  • Chorioamnionitis or other infection requiring antibiotics at the start of the labor induction
  • Previous myometrial surgery
  • Allergy to azithromycin or beta-lactam antibiotics

Treatment and study plan

Azithromycin

Drug

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

Other names: Cefazolin

Placebo

Drug

Placebo given in place of other two active drugs

Primary outcomes

  1. Rate of cesarean delivery

    Time frame: 30 days postpartum

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

Secondary outcomes

  1. Rate of chorioamnionitis development

    Time frame: 30 days postpartum

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

  2. Rate of endometritis

    Time frame: 30 days postpartum

    Maternal development of endometritis

  3. Rate of cesarean wound infection

    Time frame: 30 days postpartum

    Rate of maternal would infection from cesarean section

  4. Rate of postpartum hemorrhage

    Time frame: 30 days postpartum

    Rate of maternal postpartum hemorrhage

  5. Rate of blood transfusion

    Time frame: 30 days postpartum

    Rate of maternal blood transfusions

  6. Rate of intensive care unit admission

    Time frame: 30 days postpartum

    Maternal admission into intensive care unit

  7. Rate of hospital readmission

    Time frame: 30 days postpartum

    Maternal hospital readmission after delivery

  8. Rate of indications for cesarean delivery

    Time frame: 30 days postpartum

    Rate of indications for a cesarean delivery

  9. Maternal hospital stay

    Time frame: 30 days postpartum

    Length of maternal hospital stay

  10. Neonate hospital stay

    Time frame: 30 days postpartum

    Length of neonatal hospital stay

  11. Rate of NICU admission

    Time frame: 30 days postpartum

    Neonatal intensive care unit (NICU) admission

  12. APGAR score

    Time frame: 30 days postpartum

    5-minute APGAR score <4 (neonate)

  13. Rate of respiratory distress syndrome

    Time frame: 30 days postpartum

    Development of infant respiratory distress syndrome

  14. Rate of sepsis

    Time frame: 30 days postpartum

    Infant sepsis (either suspected or confirmed)

  15. Rate of necrotizing enterocolitis

    Time frame: 30 days postpartum

    Infant necrotizing enterocolitis

  16. Periventricular leukomalacia

    Time frame: 30 days postpartum

    Development of periventricular leukomalacia in infant as seen by ultrasound

  17. Rate of intraventricular hemorrhage

    Time frame: 30 days postpartum

    Intraventricular hemorrhage grade III or higher

  18. Neonatal death

    Time frame: 30 days postpartum

    Death of neonate

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Case Western Reserve University
  • Duke University
  • University of Alabama at Birmingham
  • University of Florida
  • University of Utah

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 5, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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