PregnancyNCT07207876
Study of Ceftriaxone and Benzathine Penicillin G During Pregnancy
An observational study of Pregnancy, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 9 sites in 2 countries.
Trial summary
IMPAACT 2044 is a study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy. Up to 78 pregnant women receiving (1) ceftriaxone for indications other than syphilis or (2) benzathine penicillin G for treatment of syphilis from non-study clinical care providers… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Ceftriaxon and Benzathine penicillin G
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 16 Feb 2026to 30 Sep 2027
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women receiving or expecting to receive ceftriaxone for indications other than syphilis or benzathine penicillin G for treatment of syphilis during pregnancy in the United States (US). The infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
Who may be able to join
- Is of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with Institutional Review Board (IRB) policies and procedures and is willing and able to provide written informed consent for her own and, if applicable (Arm 2), her infant's study participation
- At screening, has a viable singleton intrauterine pregnancy of any gestational age confirmed by fetal ultrasound, as determined by the site investigator based on medical records, with trimester documented based on the best available obstetric estimate
- At screening, is receiving or expected to receive one of the following drugs under study as prescribed by a clinical care provider and documented in medical records:
- Ceftriaxone: IV or IM administration for an indication other than syphilis
- Benzathine penicillin G: IM administration for treatment of syphilis
- At entry, expects to remain in the geographic area of the study site during pregnancy and at least 30 days postpartum
Who cannot join
- Previously enrolled in this study
- Requires desensitization to ceftriaxone or benzathine penicillin G as determined by the site investigator based on pregnant participant report and available medical records
- Has any of the following as determined by the site investigator based on pregnant participant report and available medical records:
- Current indication for hemodialysis
- Current indication for intensive care unit hospitalization
- Creatinine (Cr) ≥ 3.5 x upper limit of normal (ULN) at any time during the current pregnancy and/or chronic kidney disease Stage 5
Show all 28Show fewer
- Receipt of any of the following prohibited medications within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records:
- Probenecid
- Penicillin
- Arm 1A: any penicillin
- Arm 1B: any penicillin
- Arm 2: penicillin other than benzathine penicillin G
- Benzapril
- Chlorpropamide
- Diflunisal
- Irbesartan
- Ketoprofen
- Ketorolac tromethamine
- Meclofenamic acid
- Mefenamic acid
- Oxaprozin
- Parecoxib
- Penciclovir
- Pioglitazone
- Telmisartan
- Valsartan
- Receipt of any investigational agent within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records
- Has any documented or suspected clinically significant condition that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 sites, 8 recruiting
- Not yet recruiting
Site 5083, Rush Univ. Cook County Hosp. Chicago NICHD CRS
Chicago, Illinois, 60612
Miriam Aziz, 312-572-4265, mariam_aziz@rush.edu
- Recruiting
Site 4001, Lurie Children's Hospital of Chicago (LCH) CRS
Chicago, Illinois, 60614
Jennifer Jao, 312-227-4080, JJao@luriechildrens.org
- Recruiting
Site 5128, Baylor College of Medicine/Texas Children's Hospital NICHD CRS
Houston, Texas, 77030
Mary Paul, 832-822-1038, mpaul@bcm.edu
- Recruiting
Site 5048, USC - Maternal Child Adolescent/Adult Center
Los Angeles, California, 90033
Alice Stek, 323-865-1585, stek@usc.edu
- Recruiting
Site 5112, David Geffen School of Medicine at UCLA NICHD CRS
Los Angeles, California, 90095
Jaime Deville, 310-825-9660, jdeville@mednet.ucla.edu
- Recruiting
Site 5040, SUNY Stony Brook NICHD CRS
Stony Brook, New York, 11794
Sharon Nachman, 631-444-7692, sharon.nachman@stonybrookmedicine.edu
- Recruiting
Site 5114, Bronx-Lebanon Hospital Center NICHD CRS
The Bronx, New York, 10457
Murli Purswani, 718-960-1010, mpurswan@bronxcare.org
- Recruiting
Site 5013, Jacobi Med. Ctr. Bronx NICHD CRS
The Bronx, New York, 10461
Andrew Wiznia, 718-918-4664, andrew.wiznia@einsteinmed.edu
Puerto Rico1 site, 1 recruiting
- Recruiting
Site 5129, IMPAACT/Gamma Project/UPR Pediatric HIV/AIDS Research CRS
San Juan, 00935
Irma Febo, 787-759-9595, irma.febo2@upr.edu
About this study
Official title: Phase IV Study of the Pharmacokinetics and Safety of Ceftriaxone and Benzathine Penicillin G During Pregnancy
IMPAACT 2044 is a study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy. Up to 78 pregnant women receiving (1) ceftriaxone for indications other than syphilis or (2) benzathine penicillin G for treatment of syphilis from non-study clinical care providers will be enrolled at study sites located in the United States. Approximately 22 infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
Read the detailed description
IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy.
The study includes two arms, with Arm 1 subdivided by route of administration:
Arm 1A: Intravenous (IV) ceftriaxone Arm 1B: Intramuscular (IM) ceftriaxone Arm 2: IM benzathine penicillin G
- Conditions
- Pregnancy
- Being tested
- Ceftriaxon, Benzathine penicillin G
- Keywords
- Cefriaxone, Syphilis, Pregnancy, Benzathine Penicillin G
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxonDrug
Ceftriaxone will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider
Benzathine penicillin GDrug
Benzathine penicillin G will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider
| Study group | Role | What they receive |
|---|---|---|
| Active comparator: Arm 1A: IV ceftriaxone | Intravenous ceftriaxone Receives: Drug: Ceftriaxon | |
| Active Comparator: Arm 1B: IM ceftriaxone | Intramuscular ceftriaxone Receives: Drug: Ceftriaxon | |
| Active Comparator: Arm 2: IM benzathine penicillin G | Intramuscular benzathine penicillin G Receives: Drug: Benzathine penicillin G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester
Arm 1A
Measured: First on-study dose through 24 hours
Geometric mean terminal elimination half-life (t1/2) in the first trimester
Arm 1A
Measured: First on-study dose through 24 hours
Geometric mean trough concentration (Ctrough) in the first trimester
Arm 1A
Measured: First on-study dose through 24 hours
Geometric mean AUC0-tau in the second trimester
Arm 1A
Measured: First on-study dose through 24 hours
Geometric mean t1/2 in the second trimester
Arm 1A
Measured: First on-study dose through 24 hours
Geometric mean Ctrough in the second trimester
Arm 1A
Measured: First on-study dose through 24 hours
Geometric mean AUC0-tau in the third trimester
Arm 1A
Measured: First on-study dose through 24 hours
Geometric mean t1/2 in the third trimester
Arm 1A
Measured: First on-study dose through 24 hours
Geometric mean Ctrough in the third trimester
Arm 1A
Measured: First on-study dose through 24 hours
Median maximum plasma concentration during the dose interval (Cmax) in the first trimester
Arm 1B
Measured: First on-study dose through up to 24 hours
Median time to Cmax (Tmax) in the first trimester
Arm 1B
Measured: First on-study dose through up to 24 hours
Median Cmax in the second trimester
Arm 1B
Measured: First on-study dose through up to 24 hours
Median Tmax in the second trimester
Arm 1B
Measured: First on-study dose through up to 24 hours
Median Cmax in the third trimester
Arm 1B
Measured: First on-study dose through up to 24 hours
Median Tmax in the third trimester
Arm 1B
Measured: First on-study dose through up to 24 hours
Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester
Arm 2
Measured: First on-study dose through 7 days
Geometric mean AUC at 14 days (AUC0-14d) in the first trimester
Arm 2
Measured: First on-study dose through 14 days
Geometric mean plasma concentration at 2 hours (C2h) in the first trimester
Arm 2
Measured: 2 hours post-first on-study dose
Geometric mean plasma concentration at 24 hours (C24h) in the first trimester
Arm 2
Measured: 24 hours post-first on-study dose
Geometric mean plasma concentration at 4 days (C4d) in the first trimester
Arm 2
Measured: 4 days post-first on-study dose
Geometric mean plasma concentration at 7 days (C7d) in the first trimester
Arm 2
Measured: 7 days post-first on-study dose
Geometric mean plasma concentration at 14 days (C14d) in the first trimester
Arm 2
Measured: 14 days post-first on-study dose
Geometric mean AUC0-7d in the second trimester
Arm 2
Measured: First on-study dose through 7 days
Geometric mean AUC0-14d in the second trimester
Arm 2
Measured: First on-study dose through 14 days
Geometric mean C2h in the second trimester
Arm 2 (as defined above)
Measured: 2 hours post-first on-study dose
Geometric mean C24h in the second trimester
Arm 2 (as defined above)
Measured: 24 hours post-first on-study dose
Geometric mean C4d in the second trimester
Arm 2 (as defined above)
Measured: 4 days post-first on-study dose
Geometric mean C7d in the second trimester
Arm 2 (as defined above)
Measured: 7 days post-first on-study dose
Geometric mean C14d in the second trimester
Arm 2 (as defined above)
Measured: 14 days post-first on-study dose
Geometric mean AUC0-7d in the third trimester
Arm 2
Measured: First on-study dose through 7 days
Geometric mean AUC0-14d in the third trimester
Arm 2
Measured: First on-study dose through 14 days
Geometric mean C2h in the third trimester
Arm 2 (as defined above)
Measured: 2 hours post-first on-study dose
Geometric mean C24h in the third trimester
Arm 2 (as defined above)
Measured: 24 hours post-first on-study dose
Geometric mean C4d in the third trimester
Arm 2 (as defined above)
Measured: 4 days post-first on-study dose
Geometric mean C7d in the third trimester
Arm 2 (as defined above)
Measured: 7 days post-first on-study dose
Geometric mean C14d in the third trimester
Arm 2 (as defined above)
Measured: 14 days post-first on-study dose
Secondary outcomes (9)
Proportion of participants with a maternal serious adverse event (SAE)
Arm 1A and Arm 1B
Measured: First on-study dose through 7 days
Proportion of participants with a maternal SAE assessed as related to drug under study
Arm 1A and Arm 1B
Measured: First on-study dose through 7 days
Proportion of participants with a maternal SAE
Arm 2
Measured: First on-study dose through up to 28 days
Proportion of participants with a maternal SAE assessed as related to drug under study
Arm 2
Measured: First on-study dose through up to 28 days
Proportion of participants with a spontaneous abortion or miscarriage (<20 weeks gestation)
Arm 1A, Arm1B, and Arm 2
Measured: At pregnancy outcome/delivery/birth
Proportion of participants with a stillbirth (≥20 weeks gestation)
Arm 1A, Arm1B, and Arm 2
Measured: At pregnancy outcome/delivery/birth
Proportion of participants with an infant small for gestational age (SGA; weight <10th percentile for gestational age, adjusted for sex)
Arm 1A, Arm1B, and Arm 2
Measured: At pregnancy outcome/delivery/birth
Proportion of participants with a preterm birth (<37 weeks gestation)
Arm 1A, Arm1B, and Arm 2
Measured: At pregnancy outcome/delivery/birth
Proportion of participants with an infant congenital anomaly consistent with the definition of defect provided by Metropolitan Atlanta Congenital Defects Program (MACDP)
Arm 1A, Arm1B, and Arm 2
Measured: At pregnancy outcome/delivery/birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start16 Feb 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials Group
- Sponsor type
- Research network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jason Zucker, Study chair, Columbia Physicians & Surgeons (P&S) CRS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07207876
- Sponsor's protocol ID
- IMPAACT 2044
- Other IDs
- UM1AI068632, UM1AI068616, UM1AI106716, HHSN275201800001I
- Status last verified
- Aug 2026
- First submitted
- 19 Sep 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results in the publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Pharmacokinetics and Safety of Ceftriaxone and Benzathine Penicillin G During Pregnancy
- ClinicalTrials.gov ID
- NCT07207876
- Acronym / sponsor ID
- IMPAACT 2044
- Conditions
- Pregnancy
- Keywords
- Cefriaxone, Syphilis, Pregnancy, Benzathine Penicillin G
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- International Maternal Pediatric Adolescent AIDS Clinical Trials GroupResearch network
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH)
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 6 Oct 2025 (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.
IMPAACT 2044 is a study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy. Up to 78 pregnant women receiving (1) ceftriaxone for indications other than syphilis or (2) benzathine penicillin G for treatment of syphilis from non-study clinical care providers will be enrolled at study sites located in the United States. Approximately 22 infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
Detailed description
IMPAACT 2044 is a Phase IV, multi-site, open-label, non-randomized, opportunistic study to characterize the pharmacokinetics (PK) and safety of ceftriaxone and benzathine penicillin G during pregnancy.
The study includes two arms, with Arm 1 subdivided by route of administration:
Arm 1A: Intravenous (IV) ceftriaxone Arm 1B: Intramuscular (IM) ceftriaxone Arm 2: IM benzathine penicillin G
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active comparator: Arm 1A: IV ceftriaxone | – | Drug: CeftriaxonIntravenous ceftriaxone |
| Active Comparator: Arm 1B: IM ceftriaxone | – | Drug: CeftriaxonIntramuscular ceftriaxone |
| Active Comparator: Arm 2: IM benzathine penicillin G | – | Drug: Benzathine penicillin GIntramuscular benzathine penicillin G |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women receiving or expecting to receive ceftriaxone for indications other than syphilis or benzathine penicillin G for treatment of syphilis during pregnancy in the United States (US). The infants of pregnant participants receiving benzathine penicillin G will also be enrolled.
Key inclusion criteria (6 listed)
- Is of legal age or circumstance to provide independent informed consent as determined by site standard operating procedures (SOPs) and consistent with Institutional Review Board (IRB) policies and procedures and is willing and able to provide written informed consent for her own and, if applicable (Arm 2), her infant's study participation
- At screening, has a viable singleton intrauterine pregnancy of any gestational age confirmed by fetal ultrasound, as determined by the site investigator based on medical records, with trimester documented based on the best available obstetric estimate
- At screening, is receiving or expected to receive one of the following drugs under study as prescribed by a clinical care provider and documented in medical records:
- At entry, expects to remain in the geographic area of the study site during pregnancy and at least 30 days postpartum
Key exclusion criteria (28 listed)
- Previously enrolled in this study
- Requires desensitization to ceftriaxone or benzathine penicillin G as determined by the site investigator based on pregnant participant report and available medical records
- Has any of the following as determined by the site investigator based on pregnant participant report and available medical records:
- Receipt of any of the following prohibited medications within seven days prior to entry as determined by the site investigator based on pregnant participant report and available medical records:
- Arm 1A: any penicillin
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 |
|---|---|---|
| CeftriaxonCeftriaxone will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider | Drug | Active Comparator: Arm 1B: IM ceftriaxone, Active comparator: Arm 1A: IV ceftriaxone |
| Benzathine penicillin GBenzathine penicillin G will not be provided as part of the study. Pregnant participants will receive these drugs as prescribed outside the study by their non-study clinical care provider | Drug | Active Comparator: Arm 2: IM benzathine penicillin G |
Primary outcome
Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean terminal elimination half-life (t1/2) in the first trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean trough concentration (Ctrough) in the first trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean AUC0-tau in the second trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean t1/2 in the second trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean Ctrough in the second trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean AUC0-tau in the third trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean t1/2 in the third trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Geometric mean Ctrough in the third trimester
Time frame: First on-study dose through 24 hours
Arm 1A
Median maximum plasma concentration during the dose interval (Cmax) in the first trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median time to Cmax (Tmax) in the first trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median Cmax in the second trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median Tmax in the second trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median Cmax in the third trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Median Tmax in the third trimester
Time frame: First on-study dose through up to 24 hours
Arm 1B
Geometric mean AUC at 7 days (AUC 0-7d) in the first trimester
Time frame: First on-study dose through 7 days
Arm 2
Geometric mean AUC at 14 days (AUC0-14d) in the first trimester
Time frame: First on-study dose through 14 days
Arm 2
Geometric mean plasma concentration at 2 hours (C2h) in the first trimester
Time frame: 2 hours post-first on-study dose
Arm 2
Geometric mean plasma concentration at 24 hours (C24h) in the first trimester
Time frame: 24 hours post-first on-study dose
Arm 2
Geometric mean plasma concentration at 4 days (C4d) in the first trimester
Time frame: 4 days post-first on-study dose
Arm 2
Geometric mean plasma concentration at 7 days (C7d) in the first trimester
Time frame: 7 days post-first on-study dose
Arm 2
Geometric mean plasma concentration at 14 days (C14d) in the first trimester
Time frame: 14 days post-first on-study dose
Arm 2
Geometric mean AUC0-7d in the second trimester
Time frame: First on-study dose through 7 days
Arm 2
Geometric mean AUC0-14d in the second trimester
Time frame: First on-study dose through 14 days
Arm 2
Geometric mean C2h in the second trimester
Time frame: 2 hours post-first on-study dose
Arm 2 (as defined above)
Geometric mean C24h in the second trimester
Time frame: 24 hours post-first on-study dose
Arm 2 (as defined above)
Geometric mean C4d in the second trimester
Time frame: 4 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean C7d in the second trimester
Time frame: 7 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean C14d in the second trimester
Time frame: 14 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean AUC0-7d in the third trimester
Time frame: First on-study dose through 7 days
Arm 2
Geometric mean AUC0-14d in the third trimester
Time frame: First on-study dose through 14 days
Arm 2
Geometric mean C2h in the third trimester
Time frame: 2 hours post-first on-study dose
Arm 2 (as defined above)
Geometric mean C24h in the third trimester
Time frame: 24 hours post-first on-study dose
Arm 2 (as defined above)
Geometric mean C4d in the third trimester
Time frame: 4 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean C7d in the third trimester
Time frame: 7 days post-first on-study dose
Arm 2 (as defined above)
Geometric mean C14d in the third trimester
Time frame: 14 days post-first on-study dose
Arm 2 (as defined above)
9 secondary outcomes
Proportion of participants with a maternal serious adverse event (SAE)
Time frame: First on-study dose through 7 days
Proportion of participants with a maternal SAE assessed as related to drug under study
Time frame: First on-study dose through 7 days
Proportion of participants with a maternal SAE
Time frame: First on-study dose through up to 28 days
Proportion of participants with a maternal SAE assessed as related to drug under study
Time frame: First on-study dose through up to 28 days
Proportion of participants with a spontaneous abortion or miscarriage (<20 weeks gestation)
Time frame: At pregnancy outcome/delivery/birth
Proportion of participants with a stillbirth (≥20 weeks gestation)
Time frame: At pregnancy outcome/delivery/birth
Proportion of participants with an infant small for gestational age (SGA; weight <10th percentile for gestational age, adjusted for sex)
Time frame: At pregnancy outcome/delivery/birth
Proportion of participants with a preterm birth (<37 weeks gestation)
Time frame: At pregnancy outcome/delivery/birth
Proportion of participants with an infant congenital anomaly consistent with the definition of defect provided by Metropolitan Atlanta Congenital Defects Program (MACDP)
Time frame: At pregnancy outcome/delivery/birth
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 6 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results in the publication, after deidentification.
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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.
Jason Zucker study chair
Columbia Physicians & Surgeons (P&S) CRS
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by International Maternal Pediatric Adolescent AIDS Clinical Trials Group at 9 sites in 2 countries.
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 28 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Puerto Rico. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Lisa Levy (2028848480, impaact.ctgov@fstrf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean area under the curve (AUC) during the dosing interval (AUC0-tau) in the first trimester trimester (time frame: First on-study dose through 24 hours). The study lists 36 primary outcomes in all. 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 6 Aug 2026.