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17-alpha Hydroxyprogesterone caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study.
Am J Obstet Gynecol. 2017 06; 216(6):600.e1-600.e9.AJ

Abstract

BACKGROUND

17-alpha Hydroxyprogesterone caproate for prevention of recurrent preterm birth is recommended for use in the United States.

OBJECTIVE

We sought to assess the clinical effectiveness of 17-alpha hydroxyprogesterone caproate to prevent recurrent preterm birth ≤35 weeks compared to similar births in our obstetric population prior to the implementation of 17-alpha hydroxyprogesterone caproate.

STUDY DESIGN

This was a prospective cohort study of 17-alpha hydroxyprogesterone caproate in our obstetric population. The primary outcome was the recurrence of birth ≤35 weeks for the entire study cohort compared to a historical referent rate of 16.8% of recurrent preterm birth in our population. There were 3 secondary outcomes. First, did 17-alpha hydroxyprogesterone caproate modify a woman's history of preterm birth when taking into account her prior number and sequence of preterm and term births? Second, was recurrence of preterm birth related to 17-alpha hydroxyprogesterone caproate plasma concentration? Third, was duration of pregnancy modified by 17-alpha hydroxyprogesterone caproate treatment compared to a prior preterm birth?

RESULTS

From January 2012 through March 2016, 430 consecutive women with prior births ≤35 weeks were treated with 17-alpha hydroxyprogesterone caproate. Nearly two thirds of the women (N = 267) began injections ≤18 weeks and 394 (92%) received a scheduled weekly injection within 10 days of reaching 35 weeks or delivery. The overall rate of recurrent preterm birth was 25% (N = 106) for the entire cohort compared to the 16.8% expected rate (P = 1.0). The 3 secondary outcomes were also negative. First, 17-alpha hydroxyprogesterone caproate did not significantly reduce the rates of recurrence regardless of prior preterm birth number or sequence. Second, plasma concentrations of 17-alpha hydroxyprogesterone caproate were not different (P = .17 at 24 weeks; P = .38 at 32 weeks) between women delivered ≤35 weeks and those delivered later in pregnancy. Third, the mean (±SD) interval in weeks of recurrent preterm birth before 17-alpha hydroxyprogesterone caproate use was 0.4 ± 5.3 weeks and the interval of recurrent preterm birth after 17-alpha hydroxyprogesterone caproate treatment was 0.1 ± 4.7 weeks (P = .63). A side effect of weekly 17-alpha hydroxyprogesterone caproate injections was an increase in gestational diabetes. Specifically, the rate of gestational diabetes was 13.4% in 17-alpha hydroxyprogesterone caproate-treated women compared to 8% in case-matched controls (P = .001).

CONCLUSION

17-alpha Hydroxyprogesterone caproate was ineffective for prevention of recurrent preterm birth and was associated with an increased rate of gestational diabetes.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX. Electronic address: DavidB.Nelson@utsouthwestern.edu.Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.Department of Molecular Genetics, University of Texas Southwestern Medical Center, Dallas, TX.Women and Infant Services, Parkland Health and Hospital System, Dallas, TX.Women and Infant Services, Parkland Health and Hospital System, Dallas, TX.Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas, TX.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28223163

Citation

Nelson, David B., et al. "17-alpha Hydroxyprogesterone Caproate Did Not Reduce the Rate of Recurrent Preterm Birth in a Prospective Cohort Study." American Journal of Obstetrics and Gynecology, vol. 216, no. 6, 2017, pp. 600.e1-600.e9.
Nelson DB, McIntire DD, McDonald J, et al. 17-alpha Hydroxyprogesterone caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study. Am J Obstet Gynecol. 2017;216(6):600.e1-600.e9.
Nelson, D. B., McIntire, D. D., McDonald, J., Gard, J., Turrichi, P., & Leveno, K. J. (2017). 17-alpha Hydroxyprogesterone caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study. American Journal of Obstetrics and Gynecology, 216(6), e1-e9. https://doi.org/10.1016/j.ajog.2017.02.025
Nelson DB, et al. 17-alpha Hydroxyprogesterone Caproate Did Not Reduce the Rate of Recurrent Preterm Birth in a Prospective Cohort Study. Am J Obstet Gynecol. 2017;216(6):600.e1-600.e9. PubMed PMID: 28223163.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 17-alpha Hydroxyprogesterone caproate did not reduce the rate of recurrent preterm birth in a prospective cohort study. AU - Nelson,David B, AU - McIntire,Donald D, AU - McDonald,Jeffrey, AU - Gard,John, AU - Turrichi,Paula, AU - Leveno,Kenneth J, Y1 - 2017/02/20/ PY - 2017/01/10/received PY - 2017/02/10/revised PY - 2017/02/13/accepted PY - 2017/2/23/pubmed PY - 2017/8/5/medline PY - 2017/2/23/entrez KW - efficacy KW - external validity KW - gestational diabetes KW - neonatal morbidity KW - prematurity KW - preterm birth KW - progesterone KW - progestogen KW - randomized trial SP - 600.e1 EP - 600.e9 JF - American journal of obstetrics and gynecology JO - Am J Obstet Gynecol VL - 216 IS - 6 N2 - BACKGROUND: 17-alpha Hydroxyprogesterone caproate for prevention of recurrent preterm birth is recommended for use in the United States. OBJECTIVE: We sought to assess the clinical effectiveness of 17-alpha hydroxyprogesterone caproate to prevent recurrent preterm birth ≤35 weeks compared to similar births in our obstetric population prior to the implementation of 17-alpha hydroxyprogesterone caproate. STUDY DESIGN: This was a prospective cohort study of 17-alpha hydroxyprogesterone caproate in our obstetric population. The primary outcome was the recurrence of birth ≤35 weeks for the entire study cohort compared to a historical referent rate of 16.8% of recurrent preterm birth in our population. There were 3 secondary outcomes. First, did 17-alpha hydroxyprogesterone caproate modify a woman's history of preterm birth when taking into account her prior number and sequence of preterm and term births? Second, was recurrence of preterm birth related to 17-alpha hydroxyprogesterone caproate plasma concentration? Third, was duration of pregnancy modified by 17-alpha hydroxyprogesterone caproate treatment compared to a prior preterm birth? RESULTS: From January 2012 through March 2016, 430 consecutive women with prior births ≤35 weeks were treated with 17-alpha hydroxyprogesterone caproate. Nearly two thirds of the women (N = 267) began injections ≤18 weeks and 394 (92%) received a scheduled weekly injection within 10 days of reaching 35 weeks or delivery. The overall rate of recurrent preterm birth was 25% (N = 106) for the entire cohort compared to the 16.8% expected rate (P = 1.0). The 3 secondary outcomes were also negative. First, 17-alpha hydroxyprogesterone caproate did not significantly reduce the rates of recurrence regardless of prior preterm birth number or sequence. Second, plasma concentrations of 17-alpha hydroxyprogesterone caproate were not different (P = .17 at 24 weeks; P = .38 at 32 weeks) between women delivered ≤35 weeks and those delivered later in pregnancy. Third, the mean (±SD) interval in weeks of recurrent preterm birth before 17-alpha hydroxyprogesterone caproate use was 0.4 ± 5.3 weeks and the interval of recurrent preterm birth after 17-alpha hydroxyprogesterone caproate treatment was 0.1 ± 4.7 weeks (P = .63). A side effect of weekly 17-alpha hydroxyprogesterone caproate injections was an increase in gestational diabetes. Specifically, the rate of gestational diabetes was 13.4% in 17-alpha hydroxyprogesterone caproate-treated women compared to 8% in case-matched controls (P = .001). CONCLUSION: 17-alpha Hydroxyprogesterone caproate was ineffective for prevention of recurrent preterm birth and was associated with an increased rate of gestational diabetes. SN - 1097-6868 UR - https://www.unboundmedicine.com/medline/citation/28223163/17_alpha_Hydroxyprogesterone_caproate_did_not_reduce_the_rate_of_recurrent_preterm_birth_in_a_prospective_cohort_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9378(17)30294-6 DB - PRIME DP - Unbound Medicine ER -