Obesity in PregnancyPhase 2NCT06488781
Antibiotic Prophylaxis to Prevent Obesity-Related Induction Complications in Nulliparae at Term 2.0
A Phase 2 study testing Azithromycin in people with Obesity in Pregnancy and Labor Complication, run by University of Oklahoma at 1 site in United States.
Trial 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 (i.e. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women only
- Conditions the study is for
- Obesity in Pregnancy, Labor Complication
- What is being tested?
- Azithromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 787 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Christy Zornes, MHR, 405-271-8001 ext. 48137, christy-zornes@ouhsc.edu
Kyra Woods, BA, 405-271-8001 ext. 45750, kyra-woods@ouhsc.edu
About this study
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
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.
Read the 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 (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.
- Conditions
- Obesity in Pregnancy, Labor Complication
- Being tested
- Azithromycin, Placebo
- Medical subject headings
- Pregnancy in Obesity, Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Cefazolin
Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses
PlaceboDrug
Placebo given in place of other two active drugs
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic antibiotics | Active comparator | Azithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Placebos, similar in appearance, in place of azithromycin and cefazolin Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days postpartum
Secondary outcomes (18)
Rate of chorioamnionitis development
Defined clinically by fever and maternal and fetal signs such as tachycardia and uterine tenderness
Measured: 30 days postpartum
Rate of endometritis
Maternal development of endometritis
Measured: 30 days postpartum
Rate of cesarean wound infection
Rate of maternal would infection from cesarean section
Measured: 30 days postpartum
Rate of postpartum hemorrhage
Rate of maternal postpartum hemorrhage
Measured: 30 days postpartum
Rate of blood transfusion
Rate of maternal blood transfusions
Measured: 30 days postpartum
Rate of intensive care unit admission
Maternal admission into intensive care unit
Measured: 30 days postpartum
Rate of hospital readmission
Maternal hospital readmission after delivery
Measured: 30 days postpartum
Rate of indications for cesarean delivery
Rate of indications for a cesarean delivery
Measured: 30 days postpartum
Maternal hospital stay
Length of maternal hospital stay
Measured: 30 days postpartum
Neonate hospital stay
Length of neonatal hospital stay
Measured: 30 days postpartum
Rate of NICU admission
Neonatal intensive care unit (NICU) admission
Measured: 30 days postpartum
APGAR score
5-minute APGAR score <4 (neonate)
Measured: 30 days postpartum
Rate of respiratory distress syndrome
Development of infant respiratory distress syndrome
Measured: 30 days postpartum
Rate of sepsis
Infant sepsis (either suspected or confirmed)
Measured: 30 days postpartum
Rate of necrotizing enterocolitis
Infant necrotizing enterocolitis
Measured: 30 days postpartum
Periventricular leukomalacia
Development of periventricular leukomalacia in infant as seen by ultrasound
Measured: 30 days postpartum
Rate of intraventricular hemorrhage
Intraventricular hemorrhage grade III or higher
Measured: 30 days postpartum
Neonatal death
Death of neonate
Measured: 30 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start29 Apr 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity in PregnancyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned 1:1 to receive either the prophylactic antibiotic regimen or placebos during labor induction.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 787 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of Florida, Duke University, Case Western Reserve University, University of Utah
- Responsible party
- Sponsor
- Investigators
- Stephanie Pierce, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488781
- Sponsor's protocol ID
- APPOINT 2.0
- Status last verified
- Mar 2026
- First submitted
- 28 May 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06488781
- Acronym / sponsor ID
- APPOINT 2.0
- Conditions
- Obesity in Pregnancy, Labor Complication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 787 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham, University of Florida, Duke University, Case Western Reserve University, University of Utah
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned 1:1 to receive either the prophylactic antibiotic regimen or placebos during labor induction.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic antibiotics | Active comparator | Drug: AzithromycinAzithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses |
| Placebo | Placebo comparator | Drug: PlaceboPlacebos, similar in appearance, in place of azithromycin and cefazolin |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- BMI ≥30
- No prior deliveries at or beyond 20 weeks gestation
- Undergoing induction of labor
- Gestational age 37 weeks or more
- Age 15-45
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAlso: CefazolinAzithromycin 500 milligrams intravenously once and cefazolin 2 grams intravenously every 8 hours for up to three doses | Drug | Prophylactic antibiotics |
| PlaceboPlacebo given in place of other two active drugs | Drug | Placebo |
Primary outcome
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
18 secondary outcomes
Rate of chorioamnionitis development
Time frame: 30 days postpartum
Rate of endometritis
Time frame: 30 days postpartum
Rate of cesarean wound infection
Time frame: 30 days postpartum
Rate of postpartum hemorrhage
Time frame: 30 days postpartum
Rate of blood transfusion
Time frame: 30 days postpartum
Rate of intensive care unit admission
Time frame: 30 days postpartum
Rate of hospital readmission
Time frame: 30 days postpartum
Rate of indications for cesarean delivery
Time frame: 30 days postpartum
Maternal hospital stay
Time frame: 30 days postpartum
Neonate hospital stay
Time frame: 30 days postpartum
Rate of NICU admission
Time frame: 30 days postpartum
APGAR score
Time frame: 30 days postpartum
Rate of respiratory distress syndrome
Time frame: 30 days postpartum
Rate of sepsis
Time frame: 30 days postpartum
Rate of necrotizing enterocolitis
Time frame: 30 days postpartum
Periventricular leukomalacia
Time frame: 30 days postpartum
Rate of intraventricular hemorrhage
Time frame: 30 days postpartum
Neonatal death
Time frame: 30 days postpartum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Pierce, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin in people with Obesity in Pregnancy and Labor Complication, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Pierce, MD (405-271-8787, stephanie-pierce@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of cesarean delivery (time frame: 30 days postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.