# Pharmacokinetics and modeling of betamethasone therapy in threatened preterm birth

> **NIH NIH R01** · INDIANA UNIVERSITY INDIANAPOLIS · 2020 · $265,300

## Abstract

PROJECT SUMMARY
The primary objective of this project is to characterize the pharmacokinetic distribution and safety of
gabapentin in lactating women after a cesarean delivery. Given that cesarean delivery is the most
common surgical procedure in the United States and that pain management after surgery is crucial to
recovery, finding ways to safely and effectively manage pain and reduce opioid use is important. As
many centers are now using Enhanced Recovery After Surgery protocols for women undergoing a
cesarean delivery which include gabapentin as part of their multimodal pain control strategy, this project
is timely and needed. Reports, including our preliminary data, indicate that gabapentin can reduce
opioid use in women after cesarean delivery. While LactMed considers gabapentin to be “compatible
with breastfeeding,” the data are sparse and based on few cases. A more comprehensive
pharmacokinetic modeling study is needed. In addition, this proposal will add to the current literature by
asking participants about side effects of the drug on their baby, notably somnolence, and will
characterize postpartum opioid use at the same time, adding more safety and efficacy data for women
who breastfeed. We will accomplish this proposal in the short time for the supplement because our
busy labor unit is already using gabapentin for all women undergoing a cesarean delivery. We will
recruit women undergoing a cesarean delivery who plan to breastfeed. Our team is experienced in
consenting lactating women for pharmacokinetic studies and able to collect linked maternal blood,
breast milk, and infant blood samples successfully. They also have a track record of successfully
retaining cohorts of recruited women after delivery. Our analytical core lab is experienced in drug
measurement for our pharmacokinetic studies in pregnant women. Our therapeutic modeling team have
been creating and reporting multiple pregnancy drug models over the last several years. The team is
perfectly positioned to be able to accomplish the work in this administrative supplement proposal within
the time specified. This proposal complements the work of the parent R01, which also studies
pharmacokinetics and individualized pharmacotherapy in pregnancy. As nearly thirty-percent of
institutions using Enhanced Recovery protocols after cesarean delivery are using gabapentin, this
proposal is greatly needed to ensure that as the drug is added to more pain control regimens it is safe
to do so. The proposed work will fill an important gap in the literature and can serve as a cohort to
follow for other childhood outcomes in the future.

## Key facts

- **NIH application ID:** 10174278
- **Project number:** 3R01HD088014-05S1
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** DAVID M. HAAS
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $265,300
- **Award type:** 3
- **Project period:** 2016-03-01 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10174278

## Citation

> US National Institutes of Health, RePORTER application 10174278, Pharmacokinetics and modeling of betamethasone therapy in threatened preterm birth (3R01HD088014-05S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10174278. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*