(310) Antibiotics/Indocin for physical exam-indicated cerclages to improve latency – a protocol validation study outside Northwestern

Thursday, February 9, 2023

10:30 AM – 12:00 PM

Objective: A single center randomized trial showed improved latency with use of indomethacin/cefazolin (I/C) during and following exam-indicated cerclage (EIC), and the same center recently published a pre/post comparison demonstrating similar results. This study aims to validate the protocol outside that center.

Study Design: Retrospective cohort study of singleton pregnancies undergoing EIC at a single center between 2013 and 2022. EIC was performed for painless cervical dilation between 16-23 weeks gestation with dilation ≥1cm. The exposure was defined as receipt of I/C during and following EIC. The primary outcome was latency ≥ 28 days after cerclage placement. Secondary outcomes included latency; gestational age at delivery; delivery ≤ 28 weeks; preterm premature rupture of membranes (PPROM); intraamniotic infection (IAI); and median birth weight. Bivariate statistics were used to analyze data; multivariable regression analyses were used to control for confounders (progesterone use, cervical dilation at time of cerclage placement, history of PTB, and reduction of prolapsing membranes).

Results: EIC was placed in 81 pregnancies, and 48 (59%) received I/C. Baseline characteristics did not differ between groups (Table 1), except that prolapsing membranes were significantly less likely in patients receiving I/C (6.2 vs. 21.2%; p=0.04). Latency ≥ 28 days occurred in 90% of I/C recipients and 82% of the controls (p=0.32); this difference was not statistically significant after controlling for confounders (adjusted relative risk: 1.02 [95% CI: 0.85-1.21]). While other secondary outcomes did not differ (Table 1), I/C recipients had lower rates of IAI (4.2 vs. 24.2%, p=0.007). This difference remained after adjustment (adjusted relative risk: 0.18 [95% CI: 0.04-0.74]).

Conclusion: Use of indomethacin/cefazolin at the time of exam-indicated cerclage at our center was not associated with increased latency to delivery (albeit in a small cohort) but was associated with lower rates of intraamniotic infection. Larger-scale validation studies would be helpful to confirm the value of this intervention.

Primary Author(s)

Nicola Young, BA (she/her/hers)
Medical Student
Duke University Medical Center
Durham, North Carolina, United States

Coauthor(s)

Luke A. Gatta, MD
MFM Fellow
Duke University School of Medicine
Durham, NC, United States
Sarahn M. Wheeler, MD
Vice Chair for Equity, Diversity and Inclusion, Director Duke Prematurity Prevention Program
Duke University Medical Center
Durham, North Carolina, United States
Jerome J. Federspiel, MD, PhD
Duke University Hospital
Durham, North Carolina, United States

Presenting Author(s)

Sarah K. Dotters-Katz, MD
Assistant Professor
Duke University Medical Center
Durham, North Carolina, United States