Dataset Information

Practical considerations with 17-Hydroxyprogesterone caproate for preterm birth prevention: does timing of initiation and compliance matter?

ABSTRACT:

Objective

Determine whether gestational age of 17-hydroxyprogesterone caproate (17-OHPC) initiation is associated with preterm birth (PTB) risk.

Study design

We performed a retrospective cohort study using MarketScan® data. The primary outcome was PTB < 37 weeks. Rates of PTB were compared between medication initiation at 16-21 weeks versus 21-29 weeks. The association between compliance with weekly 17-OHPC injections and preterm birth rate was tested after adjusting for potential confounding variables.

Result

In all 3374 pregnancies met inclusion criteria. Women with an early 17-OHPC start were less likely to deliver preterm than those with a late start (aRR 0.88; 95%CI 0.79-0.97; p = 0.02). Less compliant patients receiving <25% of recommended doses had a higher PTB rate than those receiving >85% of recommended doses (aRR 1.5; 95%CI 1.2-1.7; p < 0.01).

Conclusion

There is an association between both early 17-OHPC initiation and compliance with reduced rates of PTB.

SUBMITTER: Carter EB

PROVIDER: S-EPMC6890226 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Publications

Practical considerations with 17-Hydroxyprogesterone caproate for preterm birth prevention: does timing of initiation and compliance matter?

Carter Ebony B EB Cahill Alison G AG Olsen Margaret A MA Macones George A GA Tuuli Methodius G MG Stout Molly J MJ

Journal of perinatology : official journal of the California Perinatal Association 20190619 9

<h4>Objective</h4>Determine whether gestational age of 17-hydroxyprogesterone caproate (17-OHPC) initiation is associated with preterm birth (PTB) risk.<h4>Study design</h4>We performed a retrospective cohort study using MarketScan® data. The primary outcome was PTB < 37 weeks. Rates of PTB were compared between medication initiation at 16-21 weeks versus 21-29 weeks. The association between compliance with weekly 17-OHPC injections and preterm birth rate was tested after adjusting for potential ...[more]

PMID: 31217529

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Project description:BackgroundA history of spontaneous preterm birth (sPTB) is a significant risk factor for recurrence. Intra-muscular-7α-hydroxyprogesterone caproate (17P) has been the preventive treatment of choice until the recent "Prolong study" that reported no benefit.ObjectiveTo determine the benefit of (17P) treatment in preventing reoccurrence of sPTB, by evaluating two presenting symptoms of the first sPTB: premature contractions (PMC) and preterm premature rupture of membranes (pPROM).Study designThis retrospective study included 342 women with a previous singleton sPTB followed by a subsequent pregnancy. sPTB were either due to PMC (n = 145) or pPROM (n = 197). During the subsequent pregnancy, 90 (26.3%) patients received 250 mg 17P IM. Each presenting symptom-PMC or pPROM-was evaluated within itself comparing treated vs. untreated groups. Data were analyzed using t-test, Chi-square and Fisher's exact test. Logistic regression analysis was also performed.ResultsPatients treated with 17P in the subsequent pregnancy had delivered earlier in the previous pregnancy (33.4w vs. 35.3w in the PMC group, and 34.1w vs. 35.7w in the pPROM group, p<0.001). In the following pregnancy, they had higher admission rates due to suspected preterm labor (31.7% vs. 10.9% in the treated vs. untreated PMC group (p = 0.003) and 26.1% vs. 5.4% in the treated vs. untreated pPROM group (p<0.001). In both groups, but more prominently in the previous PMC group, treatment compared to non-treatment in the subsequent pregnancy significantly prolonged it (4.3w vs. 2.6w in the PMC group (p = 0.007), and 3.7w vs. 2.7w in the pPROM group (p = 0.018)). The presenting symptom of sPTB in the following pregnancy tended to recur in cases of another sPTB, with a significantly greater likelihood of repeating the sPTB mechanism in cases with PMC, regardless of receiving 17P (69% in the PMC cohort and 60% in the pPROM cohort, p<0.001).Conclusions17P might delay preterm delivery in patients with a previous sPTB on an individual level (prolongation of the pregnancy for each patient compared to her previous delivery). Therefore, our results imply that 17P can decrease potential premature delivery complications for patients with a previous sPTB due to PMC or pPROM.

Project description:Background17-alpha Hydroxyprogesterone caproate for prevention of recurrent preterm birth is recommended for use in the United States.ObjectiveWe 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 designThis 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?ResultsFrom 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).Conclusion17-alpha Hydroxyprogesterone caproate was ineffective for prevention of recurrent preterm birth and was associated with an increased rate of gestational diabetes.

Dataset Information

Practical considerations with 17-Hydroxyprogesterone caproate for preterm birth prevention: does timing of initiation and compliance matter?

Objective

Study design

Result

Conclusion

Publications

Practical considerations with 17-Hydroxyprogesterone caproate for preterm birth prevention: does timing of initiation and compliance matter?

Similar Datasets

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